Acas Carotid Trial
2021年4月9日Register here: http://gg.gg/ozgo2
*Acas Carotid Trial Procedure
*Acas Carotid Trial Definition
*Acas Trial Carotid StenosisPlain English Summary
*The NASCET and ECST trials have shown benefit for symptomatic patients from carotid endarterectomy. ACAS demonstrated that the incidence of cerebral infarction can be reduced by endarterectomy, and forms the foundation for current clinical guidelines for asymptomatic patients.
*With asymptomatic carotid stenosis come from the Asymptomatic Carotid Atherosclerosis Study (ACAS) and the Asymptomatic Carotid Surgery Trial (ACST; Current Controlled Trials number, ISRCTN26156392).1,2 Although stroke may be the most feared consequence of carotid disease, the most common adverse event in these studies was.
*Two landmark RCTs, the Asymptomatic Carotid Atherosclerosis Study (ACAS) and the Asymptomatic Carotid Surgery Trial (ACST), determined that CEA conferred a small but significant benefit over BMT in patients with an ipsilateral 60%–99% ICA stenosis.30 31 Unlike in NASCET and ECST, it was more difficult to identify subgroups of patients who.
The two randomized controlled studies mostly referenced on the subject of “asymptomatic” carotid stenosis are the Asymptomatic Carotid Atherosclerosis Study (ACAS) with 1662 and the Asymptomatic Carotid Surgery Trial (ACST) with 3120 patients 5, 6. Table 1 summarizes the most important results of the aforementioned studies 3–6, 33–38.
Background and study aimsCarotid stenosis is a condition where one or both of the carotid arteries (the main blood vessels that supply the head and neck) become narrowed due to a build-up of fatty deposits (plaque). This increases the risk of having a stroke, when the blood supply to part of the brain is cut off. The aim of this study is to compare carotid surgery (carotid endarterectomy or CEA) with the best medical treatment (BMT) in patients with carotid stenosis but no symptoms. The aim of this study is to find out whether CEA and BMT together improve stroke-free survival time when compared to BMT alone. The study also aims to identify high-risk groups for whom the benefits of surgery and of BMT are increased and the long-term follow-up is looking at whether carotid endarterectomy reduces the risk of dementia in the long-term.Who can participate? Patients whose carotid stenosis has not caused symptoms for at least 6 months, and who have no past history of stroke What does the study involve? Participants are randomly allocated to be treated with either CEA plus BMT or BMT alone, unless symptoms develop requiring a CEA. Fatal and non-fatal stroke and death rates are compared between the two groups. For long-term follow-up the UK and Swedish participants’ health records are also analysed for rates of stroke, death and dementia in the long-term. Relatives or friends of the UK participants are also asked to complete a postal questionnaire about the participant’s cognitive (mental) function.What are the possible benefits and risks of participating? There is no direct benefit to taking part but the information gained may help doctors to treat patients with asymptomatic carotid disease better in the future. There is no additional risk to taking part in this study. Long-term follow-up: there is no direct benefit to taking part but this follow-up may contribute to a wider benefit if carotid surgery is found to reduce the risk of developing later memory and thinking problems. The long-term follow-up does not involve any additional physical risk to the participants or does not provide any risk in relation to loss of anonymity.Where is the study run from? John Radcliffe Hospital (UK)When is the study starting and how long is it expected to run for? April 1993 to October 2019Who is funding the study? 1. Medical Research Council (MRC) (UK)2. Alzheimer’s Society (UK)Who is the main contact?Alison Hallidayacst@nds.ox.ac.ukTrial websiteContact informationType
Scientific Primary contact
Prof Alison Halliday ORCID IDContact details
ACST Trials Office Level 6 West Wing John Radcliffe Hospital Headley Way Oxford OX3 9DU United Kingdom +44 (0)1865 617975acst@nds.ox.ac.ukType
Public Additional contact
Ms Mary Sneade ORCID IDContact details
ACST trials office Richard Doll Building Old Road Campus Roosevelt Drive Oxford OX3 7LF United Kingdom +44 (0)1865 617978acst@nds.ox.ac.ukAdditional identifiersEudraCT numberClinicalTrials.gov numberProtocol/serial number
G9408332 Study informationScientific title
Asymptomatic Carotid Surgery Trial (ACST-1) Acronym
ACST-1 Acas Carotid Trial ProcedureStudy hypothesis
The aim is to determine whether CEA and BMT improve stroke-free survival time when compared to BMT alone. The trial will also help identify high-risk groups in whom the benefits of surgery and of BMT would be increased.Added 21/02/2017:Primary objective: In participants with carotid stenosis, does carotid endarterectomy reduce the long-term risk of dementia, stroke or death related to carotid stenosis?Secondary objective: In patients with carotid stenosis, does the long-term risk of dementia, stroke or death in recorded electronic records vary by duration of follow up, or participant characteristic recorded at baseline?Updated 28/09/2018:Primary objective: In participants with asymptomatic carotid stenosis, does carotid endarterectomy reduce the long-term risk of stroke, dementia or death, related to carotid stenosis?Secondary objective: In patients with carotid stenosis, does the long-term risk of dementia or stroke in recorded electronic health records vary by duration of follow-up, or participant characteristic recorded at baseline? Ethics approval
London Research Ethics Committee, 11/11/1998, ref: 98/2/92 Study design
Randomised controlled trial Primary study design
Interventional Secondary study design
Randomised controlled trial Trial setting
Hospitals Trial type
Treatment Patient information sheet
Not available in web format, please use contact details to request a participant information sheet Condition
Carotid stenosis Intervention
CEA and best medical treatment (BMT) vs BMT aloneAdded 19/08/2008: follow-up is a minimum of 5 yearsAdded 21/02/2017:No further treatment interventions are planned as part of the long-term follow-up study. Phase 1: Analysis of long-term data from UK and Swedish ACST-1 participant’s health records through electronic data linkage (NHS digital, UK; Socialstyrelsen, Sweden) for specific outcomes of incident stroke, death and dementia (16/SC/0406). The trialists will also be applying to the equivalent regulatory authorities in Scotland and Northern Ireland.Phase 2: A relative or friend of the ACST-1 UK participants will be invited to complete a postal questionnaire (Informant Questionnaire on Cognitive decline in the Elderly-IQCODE) on the participant’s cognitive function. Updated 28/09/2018:No further treatment interventions are planned as part of the long-term follow-up study. Phase 1: Phase 1: Analysis of long-term data from UK and Swedish ACST-1 participant’s health records through electronic data linkage (NHS digital, UK; Socialstyrelsen, Sweden) for specific outcomes of incident stroke and dementia (ethics approved 16/SC/0406).Phase 2: A relative or friend of the ACST-1 UK participants will be invited to complete a postal questionnaire (short form of the validated ‘Informant Questionnaire on Cognitive decline in the Elderly’ - IQCODE) on the participant’s cognitive function. Intervention type
Procedure/Surgery PhaseDrug namesPrimary outcome measure
Fatal and non-fatal stroke and death ratesAdded 10/03/2017:Long-term follow-up to determine specific outcomes of stroke and cognitive decline:1. Long-term risk of dementia, stroke or death, measured using participant’s health records through electronic data linkage (NHS digital, UK; Socialstyrelsen, Sweden) at least 14 years post enrolment2. Cognitive function, measured using the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE), MoCA and TICS-N, at least 14 years post enrolmentUpdated 28/09/2018:Long-term follow-up to determine specific outcomes of stroke and cognitive decline:1. Long-term risk of dementia, stroke or death, measured using participant’s health records through electronic data linkage (NHS digital, UK; Socialstyrelsen, Sweden) at least 14 years post enrolment2. Cognitive function, measured using the short form of the validated Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE), at least 14 years post enrolment Secondary outcome measures
Subsidiary analyses in an effort to identify high and low risk groups will include the effect of risk factors such as presence or absence of silent cerebral infarction on clinical outcome Overall trial start date
01/04/1993 Overall trial end date
01/10/2019 Reason abandoned (if study stopped)EligibilityParticipant inclusion criteria
1. Patients whose carotid stenosis has not caused symptoms for at least 6 months2. No past history of ipsilateral disabling or severe contralateral stroke3. No clear indications or contraindications to carotid endarterectomy (CEA) Participant type
Patient Age group
Adult Gender
Both Target number of participants
3120; 1601 for long-term follow-up Participant exclusion criteria
1. Patients with a small likelihood of worthwhile benefit e.g. those with major life-threatening disease. 2. Patients who have had recent myocardial infarct, intracerebral neoplasia or aneurysm, or restenosis of an artery following previous CEA Recruitment start date
19/04/1993 Recruitment end date
01/05/2003 LocationsCountries of recruitment
Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Cyprus, Czech Republic, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Russian Federation, Slovenia, Spain, Sweden, Switzerland, Tunisia, United Kingdom, United States of America Trial participating centre
John Radcliffe Hospital Oxford OX3 9DU United KingdomTrial participating centre
123 other centres - United KingdomSponsor informationOrganisation
Medical Research Council (MRC) (UK) Sponsor details
20 Park Crescent London W1B 1AL United Kingdom +44 (0)20 7636 5422clinical.trial@headoffice.mrc.ac.ukSponsor type
Research council WebsiteOrganisation
University of Oxford Sponsor details
Research Services Clinical Trials and Research Governance (CTRG) Joint Research Office 1st Floor Boundary Brook House Churchill Drive Headington Oxford OX3 7GB United Kingdom -ctrg@admin.ox.ac.ukSponsor type
University/education WebsiteOrganisation
University of Oxford Sponsor detailsSponsor type
Not defined WebsiteFundersFunder type
Research council Funder name
Medical Research Council (MRC) (UK) Alternative name(s)
MRC Funding Body Type
government organisation Funding Body Subtype
National government Acas Carotid Trial DefinitionLocation
United Kingdom Funder name
Alzheimer’s Society Alternative name(s)Funding Body Type
private sector organisation Funding Body Subtype
Associations and societies (private and public) Location
United Kingdom Results and PublicationsPublication and dissemination plan
The long-term follow-up results are anticipated to be presented at relevant scientific forums and conferences in the spring 2019 and published end of 2019 in peer-reviewed scientific journals.IPD sharing planThe datasets generated during and/or analysed during the current study are not expected to be made available. Intention to publish date
31/10/2019 Participant level data
Not expected to be available Basic results (scientific)Publication list
2004 results in: http://www.ncbi.nlm.nih.gov/pubmed/151355942010 results in: http://www.ncbi.nlm.nih.gov/pubmed/208700992013 results in: http://www.ncbi.nlm.nih.gov/pubmed/236329802016 results in: http://www.ncbi.nlm.nih.gov/pubmed/274352052016 results in: http://www.ncbi.nlm.nih.gov/pubmed/273223792016 results in: http://www.ncbi.nlm.nih.gov/pubmed/271118092016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26725253Publication citations
*
Results
Halliday A, Mansfield A, Marro J, Peto C, Peto R, Potter J, Thomas D, , Prevention of disabling and fatal strokes by successful carotid endarterectomy in patients without recent neurological symptoms: randomised controlled trial., Lancet, 2004, 363, 9420, 1491-1502, doi: 10.1016/S0140-6736(04)16146-1.
*
Results
Halliday A, Harrison M, Hayter E, Kong X, Mansfield A, Marro J, Pan H, Peto R, Potter J, Rahimi K, Rau A, Robertson S, Streifler J, Thomas D, , 10-year stroke prevention after successful carotid endarterectomy for asymptomatic stenosis (ACST-1): a multicentre randomised trial., Lancet, 2010, 376, 9746, 1074-1084, doi: 10.1016/S0140-6736(10)61197-X.Additional filesEditorial Notes 02/10/2018: The intention to publish date was changed from 01/10/2018 to 31/10/2019.28/09/2018: The following changes were made to the trial record:1. The study hypothesis, interventions and primary outcome measure fields were updated.2. The overall trial end date was changed from 31/12/2018 to 01/10/2019.3. Contact and sponsor details updated.18/09/2017: Contact details updated.21/02/2017: The following changes were made to the trial record:1. The overall trial end date was changed from 31/03/2004 to 31/12/2018.2. The target number of participants was changed from ’3120’ to ’3120; 1601 for long-term follow-up’.3. Alzheimer’s Society was added as a funder for the long-term follow up.4. The acronym was changed from ACST to ACST-1.5. Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Cyprus, Czech Republic, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, New Zealand, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Netherlands, Tunisia and USA were added to the countries of recruitment.6. University of Oxford was added as a sponsor.27/01/2017: Publication references added. Perspective:
The following are 10 points to remember about asymptomatic carotid stenosis: 1. With modern intensive medical therapy, the risk of stroke in patients with asymptomatic carotid stenosis is now much lower than it was when the earlier trials, ACAS (Asymptomatic Carotid Atherosclerosis Study) and ACST (Asymptomatic Carotid Stenosis Trial), were conducted. 2. In contrast to symptomatic carotid stenosis, in asymptomatic carotid stenosis, the severity of stenosis does not predict risk. 3. It is disturbing that in the United States, the indication for approximately 90% of carotid endarterectomy and stenting is asymptomatic carotid stenosis based on extrapolation from CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial), a modern study of stenting versus endarterectomy without a medical arm of therapy, to historical results from the medical arms of early studies of carotid endarterectomy, which were performed during a time when medical therapy was much less effective. 4. This extrapolation is not valid, because with modern medical therapy, the risk of stroke in patients with asymptomatic carotid stenosis is much lower than it was in the two historical trials that are used to justify this practice. 5. The risks of stroke or death in CREST cannot legitimately be used to justify stenting or endarterectomy in unselected patients with asymptomatic carotid stenosis. 6. Transcranial Doppler embolus detection may identify the 10% of patients who would be at high enough risk to benefit from endarterectomy or stenting. 7. Additional indications of high-risk asymptomatic carotid stenosis include ulceration of carotid plaques on three-dimensional carotid ultrasound, intraplaque hemorrhage on magnetic resonance imaging, and echolucency of carotid plaques. 8. We need randomized controlled trials with a medical arm that compares stenting, endarterectomy, and modern intensive medical therapy in patients with asymptomatic carotid stenosis to assess true safety/efficacy of revascularization. 9. The proposed CREST-2 trial proposes exactly that comparison. 10. With asymptomatic carotid stenosis, patients clearly warrant intensive medical therapy to reduce their high risk of coronary events in addition to their risk of stroke.
Clinical Topics:Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Vascular Medicine, Interventions and Imaging, Interventions and Vascular Medicine, Magnetic Resonance Imaging
Keywords:Stroke, Endarterectomy, Carotid, Carotid Artery Diseases, Constriction, Pathologic, Embolism, Carotid Stenosis, Magnetic Resonance Imaging, United States, Stents< Back to ListingsAcas Trial Carotid Stenosis
Register here: http://gg.gg/ozgo2
https://diarynote-jp.indered.space
*Acas Carotid Trial Procedure
*Acas Carotid Trial Definition
*Acas Trial Carotid StenosisPlain English Summary
*The NASCET and ECST trials have shown benefit for symptomatic patients from carotid endarterectomy. ACAS demonstrated that the incidence of cerebral infarction can be reduced by endarterectomy, and forms the foundation for current clinical guidelines for asymptomatic patients.
*With asymptomatic carotid stenosis come from the Asymptomatic Carotid Atherosclerosis Study (ACAS) and the Asymptomatic Carotid Surgery Trial (ACST; Current Controlled Trials number, ISRCTN26156392).1,2 Although stroke may be the most feared consequence of carotid disease, the most common adverse event in these studies was.
*Two landmark RCTs, the Asymptomatic Carotid Atherosclerosis Study (ACAS) and the Asymptomatic Carotid Surgery Trial (ACST), determined that CEA conferred a small but significant benefit over BMT in patients with an ipsilateral 60%–99% ICA stenosis.30 31 Unlike in NASCET and ECST, it was more difficult to identify subgroups of patients who.
The two randomized controlled studies mostly referenced on the subject of “asymptomatic” carotid stenosis are the Asymptomatic Carotid Atherosclerosis Study (ACAS) with 1662 and the Asymptomatic Carotid Surgery Trial (ACST) with 3120 patients 5, 6. Table 1 summarizes the most important results of the aforementioned studies 3–6, 33–38.
Background and study aimsCarotid stenosis is a condition where one or both of the carotid arteries (the main blood vessels that supply the head and neck) become narrowed due to a build-up of fatty deposits (plaque). This increases the risk of having a stroke, when the blood supply to part of the brain is cut off. The aim of this study is to compare carotid surgery (carotid endarterectomy or CEA) with the best medical treatment (BMT) in patients with carotid stenosis but no symptoms. The aim of this study is to find out whether CEA and BMT together improve stroke-free survival time when compared to BMT alone. The study also aims to identify high-risk groups for whom the benefits of surgery and of BMT are increased and the long-term follow-up is looking at whether carotid endarterectomy reduces the risk of dementia in the long-term.Who can participate? Patients whose carotid stenosis has not caused symptoms for at least 6 months, and who have no past history of stroke What does the study involve? Participants are randomly allocated to be treated with either CEA plus BMT or BMT alone, unless symptoms develop requiring a CEA. Fatal and non-fatal stroke and death rates are compared between the two groups. For long-term follow-up the UK and Swedish participants’ health records are also analysed for rates of stroke, death and dementia in the long-term. Relatives or friends of the UK participants are also asked to complete a postal questionnaire about the participant’s cognitive (mental) function.What are the possible benefits and risks of participating? There is no direct benefit to taking part but the information gained may help doctors to treat patients with asymptomatic carotid disease better in the future. There is no additional risk to taking part in this study. Long-term follow-up: there is no direct benefit to taking part but this follow-up may contribute to a wider benefit if carotid surgery is found to reduce the risk of developing later memory and thinking problems. The long-term follow-up does not involve any additional physical risk to the participants or does not provide any risk in relation to loss of anonymity.Where is the study run from? John Radcliffe Hospital (UK)When is the study starting and how long is it expected to run for? April 1993 to October 2019Who is funding the study? 1. Medical Research Council (MRC) (UK)2. Alzheimer’s Society (UK)Who is the main contact?Alison Hallidayacst@nds.ox.ac.ukTrial websiteContact informationType
Scientific Primary contact
Prof Alison Halliday ORCID IDContact details
ACST Trials Office Level 6 West Wing John Radcliffe Hospital Headley Way Oxford OX3 9DU United Kingdom +44 (0)1865 617975acst@nds.ox.ac.ukType
Public Additional contact
Ms Mary Sneade ORCID IDContact details
ACST trials office Richard Doll Building Old Road Campus Roosevelt Drive Oxford OX3 7LF United Kingdom +44 (0)1865 617978acst@nds.ox.ac.ukAdditional identifiersEudraCT numberClinicalTrials.gov numberProtocol/serial number
G9408332 Study informationScientific title
Asymptomatic Carotid Surgery Trial (ACST-1) Acronym
ACST-1 Acas Carotid Trial ProcedureStudy hypothesis
The aim is to determine whether CEA and BMT improve stroke-free survival time when compared to BMT alone. The trial will also help identify high-risk groups in whom the benefits of surgery and of BMT would be increased.Added 21/02/2017:Primary objective: In participants with carotid stenosis, does carotid endarterectomy reduce the long-term risk of dementia, stroke or death related to carotid stenosis?Secondary objective: In patients with carotid stenosis, does the long-term risk of dementia, stroke or death in recorded electronic records vary by duration of follow up, or participant characteristic recorded at baseline?Updated 28/09/2018:Primary objective: In participants with asymptomatic carotid stenosis, does carotid endarterectomy reduce the long-term risk of stroke, dementia or death, related to carotid stenosis?Secondary objective: In patients with carotid stenosis, does the long-term risk of dementia or stroke in recorded electronic health records vary by duration of follow-up, or participant characteristic recorded at baseline? Ethics approval
London Research Ethics Committee, 11/11/1998, ref: 98/2/92 Study design
Randomised controlled trial Primary study design
Interventional Secondary study design
Randomised controlled trial Trial setting
Hospitals Trial type
Treatment Patient information sheet
Not available in web format, please use contact details to request a participant information sheet Condition
Carotid stenosis Intervention
CEA and best medical treatment (BMT) vs BMT aloneAdded 19/08/2008: follow-up is a minimum of 5 yearsAdded 21/02/2017:No further treatment interventions are planned as part of the long-term follow-up study. Phase 1: Analysis of long-term data from UK and Swedish ACST-1 participant’s health records through electronic data linkage (NHS digital, UK; Socialstyrelsen, Sweden) for specific outcomes of incident stroke, death and dementia (16/SC/0406). The trialists will also be applying to the equivalent regulatory authorities in Scotland and Northern Ireland.Phase 2: A relative or friend of the ACST-1 UK participants will be invited to complete a postal questionnaire (Informant Questionnaire on Cognitive decline in the Elderly-IQCODE) on the participant’s cognitive function. Updated 28/09/2018:No further treatment interventions are planned as part of the long-term follow-up study. Phase 1: Phase 1: Analysis of long-term data from UK and Swedish ACST-1 participant’s health records through electronic data linkage (NHS digital, UK; Socialstyrelsen, Sweden) for specific outcomes of incident stroke and dementia (ethics approved 16/SC/0406).Phase 2: A relative or friend of the ACST-1 UK participants will be invited to complete a postal questionnaire (short form of the validated ‘Informant Questionnaire on Cognitive decline in the Elderly’ - IQCODE) on the participant’s cognitive function. Intervention type
Procedure/Surgery PhaseDrug namesPrimary outcome measure
Fatal and non-fatal stroke and death ratesAdded 10/03/2017:Long-term follow-up to determine specific outcomes of stroke and cognitive decline:1. Long-term risk of dementia, stroke or death, measured using participant’s health records through electronic data linkage (NHS digital, UK; Socialstyrelsen, Sweden) at least 14 years post enrolment2. Cognitive function, measured using the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE), MoCA and TICS-N, at least 14 years post enrolmentUpdated 28/09/2018:Long-term follow-up to determine specific outcomes of stroke and cognitive decline:1. Long-term risk of dementia, stroke or death, measured using participant’s health records through electronic data linkage (NHS digital, UK; Socialstyrelsen, Sweden) at least 14 years post enrolment2. Cognitive function, measured using the short form of the validated Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE), at least 14 years post enrolment Secondary outcome measures
Subsidiary analyses in an effort to identify high and low risk groups will include the effect of risk factors such as presence or absence of silent cerebral infarction on clinical outcome Overall trial start date
01/04/1993 Overall trial end date
01/10/2019 Reason abandoned (if study stopped)EligibilityParticipant inclusion criteria
1. Patients whose carotid stenosis has not caused symptoms for at least 6 months2. No past history of ipsilateral disabling or severe contralateral stroke3. No clear indications or contraindications to carotid endarterectomy (CEA) Participant type
Patient Age group
Adult Gender
Both Target number of participants
3120; 1601 for long-term follow-up Participant exclusion criteria
1. Patients with a small likelihood of worthwhile benefit e.g. those with major life-threatening disease. 2. Patients who have had recent myocardial infarct, intracerebral neoplasia or aneurysm, or restenosis of an artery following previous CEA Recruitment start date
19/04/1993 Recruitment end date
01/05/2003 LocationsCountries of recruitment
Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Cyprus, Czech Republic, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Russian Federation, Slovenia, Spain, Sweden, Switzerland, Tunisia, United Kingdom, United States of America Trial participating centre
John Radcliffe Hospital Oxford OX3 9DU United KingdomTrial participating centre
123 other centres - United KingdomSponsor informationOrganisation
Medical Research Council (MRC) (UK) Sponsor details
20 Park Crescent London W1B 1AL United Kingdom +44 (0)20 7636 5422clinical.trial@headoffice.mrc.ac.ukSponsor type
Research council WebsiteOrganisation
University of Oxford Sponsor details
Research Services Clinical Trials and Research Governance (CTRG) Joint Research Office 1st Floor Boundary Brook House Churchill Drive Headington Oxford OX3 7GB United Kingdom -ctrg@admin.ox.ac.ukSponsor type
University/education WebsiteOrganisation
University of Oxford Sponsor detailsSponsor type
Not defined WebsiteFundersFunder type
Research council Funder name
Medical Research Council (MRC) (UK) Alternative name(s)
MRC Funding Body Type
government organisation Funding Body Subtype
National government Acas Carotid Trial DefinitionLocation
United Kingdom Funder name
Alzheimer’s Society Alternative name(s)Funding Body Type
private sector organisation Funding Body Subtype
Associations and societies (private and public) Location
United Kingdom Results and PublicationsPublication and dissemination plan
The long-term follow-up results are anticipated to be presented at relevant scientific forums and conferences in the spring 2019 and published end of 2019 in peer-reviewed scientific journals.IPD sharing planThe datasets generated during and/or analysed during the current study are not expected to be made available. Intention to publish date
31/10/2019 Participant level data
Not expected to be available Basic results (scientific)Publication list
2004 results in: http://www.ncbi.nlm.nih.gov/pubmed/151355942010 results in: http://www.ncbi.nlm.nih.gov/pubmed/208700992013 results in: http://www.ncbi.nlm.nih.gov/pubmed/236329802016 results in: http://www.ncbi.nlm.nih.gov/pubmed/274352052016 results in: http://www.ncbi.nlm.nih.gov/pubmed/273223792016 results in: http://www.ncbi.nlm.nih.gov/pubmed/271118092016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26725253Publication citations
*
Results
Halliday A, Mansfield A, Marro J, Peto C, Peto R, Potter J, Thomas D, , Prevention of disabling and fatal strokes by successful carotid endarterectomy in patients without recent neurological symptoms: randomised controlled trial., Lancet, 2004, 363, 9420, 1491-1502, doi: 10.1016/S0140-6736(04)16146-1.
*
Results
Halliday A, Harrison M, Hayter E, Kong X, Mansfield A, Marro J, Pan H, Peto R, Potter J, Rahimi K, Rau A, Robertson S, Streifler J, Thomas D, , 10-year stroke prevention after successful carotid endarterectomy for asymptomatic stenosis (ACST-1): a multicentre randomised trial., Lancet, 2010, 376, 9746, 1074-1084, doi: 10.1016/S0140-6736(10)61197-X.Additional filesEditorial Notes 02/10/2018: The intention to publish date was changed from 01/10/2018 to 31/10/2019.28/09/2018: The following changes were made to the trial record:1. The study hypothesis, interventions and primary outcome measure fields were updated.2. The overall trial end date was changed from 31/12/2018 to 01/10/2019.3. Contact and sponsor details updated.18/09/2017: Contact details updated.21/02/2017: The following changes were made to the trial record:1. The overall trial end date was changed from 31/03/2004 to 31/12/2018.2. The target number of participants was changed from ’3120’ to ’3120; 1601 for long-term follow-up’.3. Alzheimer’s Society was added as a funder for the long-term follow up.4. The acronym was changed from ACST to ACST-1.5. Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Cyprus, Czech Republic, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, New Zealand, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Netherlands, Tunisia and USA were added to the countries of recruitment.6. University of Oxford was added as a sponsor.27/01/2017: Publication references added. Perspective:
The following are 10 points to remember about asymptomatic carotid stenosis: 1. With modern intensive medical therapy, the risk of stroke in patients with asymptomatic carotid stenosis is now much lower than it was when the earlier trials, ACAS (Asymptomatic Carotid Atherosclerosis Study) and ACST (Asymptomatic Carotid Stenosis Trial), were conducted. 2. In contrast to symptomatic carotid stenosis, in asymptomatic carotid stenosis, the severity of stenosis does not predict risk. 3. It is disturbing that in the United States, the indication for approximately 90% of carotid endarterectomy and stenting is asymptomatic carotid stenosis based on extrapolation from CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial), a modern study of stenting versus endarterectomy without a medical arm of therapy, to historical results from the medical arms of early studies of carotid endarterectomy, which were performed during a time when medical therapy was much less effective. 4. This extrapolation is not valid, because with modern medical therapy, the risk of stroke in patients with asymptomatic carotid stenosis is much lower than it was in the two historical trials that are used to justify this practice. 5. The risks of stroke or death in CREST cannot legitimately be used to justify stenting or endarterectomy in unselected patients with asymptomatic carotid stenosis. 6. Transcranial Doppler embolus detection may identify the 10% of patients who would be at high enough risk to benefit from endarterectomy or stenting. 7. Additional indications of high-risk asymptomatic carotid stenosis include ulceration of carotid plaques on three-dimensional carotid ultrasound, intraplaque hemorrhage on magnetic resonance imaging, and echolucency of carotid plaques. 8. We need randomized controlled trials with a medical arm that compares stenting, endarterectomy, and modern intensive medical therapy in patients with asymptomatic carotid stenosis to assess true safety/efficacy of revascularization. 9. The proposed CREST-2 trial proposes exactly that comparison. 10. With asymptomatic carotid stenosis, patients clearly warrant intensive medical therapy to reduce their high risk of coronary events in addition to their risk of stroke.
Clinical Topics:Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Vascular Medicine, Interventions and Imaging, Interventions and Vascular Medicine, Magnetic Resonance Imaging
Keywords:Stroke, Endarterectomy, Carotid, Carotid Artery Diseases, Constriction, Pathologic, Embolism, Carotid Stenosis, Magnetic Resonance Imaging, United States, Stents< Back to ListingsAcas Trial Carotid Stenosis
Register here: http://gg.gg/ozgo2
https://diarynote-jp.indered.space
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