Asymptomatic Carotid Surgery Trial (ACST-1)
| ISRCTN | ISRCTN26156392 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26156392 |
| Secondary identifying numbers | G9408332 |
- Submission date
- 23/10/2000
- Registration date
- 23/10/2000
- Last edited
- 02/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Carotid 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 2019
Who is funding the study?
1. Medical Research Council (MRC) (UK)
2. Alzheimer’s Society (UK)
Who is the main contact?
Alison Halliday
acst@nds.ox.ac.uk
Contact information
Scientific
ACST Trials Office
Level 6, West Wing
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom
 ORCID ID |
0000-0001-9828-3579 |
|---|---|
| Phone | +44 (0)1865 617975 |
| acst@nds.ox.ac.uk |
Public
ACST trials office
Richard Doll Building, Old Road Campus
Roosevelt Drive
Oxford
OX3 7LF
United Kingdom
| ORCID ID |
0000-0002-8860-0363 |
|---|---|
| Phone | +44 (0)1865 617978 |
| acst@nds.ox.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Asymptomatic Carotid Surgery Trial (ACST-1) |
| Study acronym | ACST-1 |
| Study 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(s) | London Research Ethics Committee, 11/11/1998, ref: 98/2/92 |
| Condition | Carotid stenosis |
| Intervention | CEA and best medical treatment (BMT) vs BMT alone Added 19/08/2008: follow-up is a minimum of 5 years Added 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 |
| Primary outcome measure | Fatal and non-fatal stroke and death rates Added 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 enrolment 2. Cognitive function, measured using the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE), MoCA and TICS-N, at least 14 years post enrolment Updated 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 enrolment 2. 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 study start date | 01/04/1993 |
| Overall study end date | 01/10/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 3120; 1601 for long-term follow-up |
| Participant inclusion criteria | 1. Patients whose carotid stenosis has not caused symptoms for at least 6 months 2. No past history of ipsilateral disabling or severe contralateral stroke 3. No clear indications or contraindications to carotid endarterectomy (CEA) |
| 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 |
Locations
Countries of recruitment
- Austria
- Belgium
- Brazil
- Bulgaria
- Canada
- Croatia
- Cyprus
- Czech Republic
- England
- 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
Study participating centres
OX3 9DU
United Kingdom
United Kingdom
Sponsor information
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
University/education
Research Services
Clinical Trials and Research Governance (CTRG)
Joint Research Office
1st Floor, Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
England
United Kingdom
| ctrg@admin.ox.ac.uk | |
| Website | https://researchsupport.admin.ox.ac.uk/ctrg |
Not defined
| Website | http://www.ox.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- alzheimerssoc
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/10/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication 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 plan | The datasets generated during and/or analysed during the current study are not expected to be made available. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 08/05/2004 | Yes | No | |
| Results article | results | 25/09/2010 | Yes | No | |
| Results article | results | 01/06/2013 | Yes | No | |
| Results article | results | 01/05/2016 | Yes | No | |
| Results article | results | 01/12/2016 | Yes | No | |
| Results article | results | 01/12/2016 | Yes | No | |
| Results article | results | 01/12/2016 | Yes | No |
Editorial 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.
