Carotid StenosisNCT03929354
Lifestyle Modification Programme for Patients With Asymptomatic Carotid Artery Stenosis
A study testing Risk Factors Modification Programme in people with Carotid Stenosis, run by Western Vascular Institute, Ireland at 1 site in Ireland.
Trial summary
This study randomises patients with patients with asymptomatic carotid artery stenosis, to be managed either by providing an intensive 12-week lifestyle modification programme, or standard healthcare. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- Risk Factors Modification Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteIreland
- Study dates
- 1 Jun 2018to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or more.
- Provide written informed consent.
- History of asymptomatic carotid artery stenosis, defined as a stenosis of the internal carotid artery of 50% or higher, but without history of any cerebrovascular events within the previous 6 months.
- Patients should have at least one of the following risk factors:
- Blood pressure > 140/80 mmHg
- Fasting blood sugar > 53 mmol/mol (HbA1c > 7%)
Show all 15Show fewer
- Total cholesterol > 5 mmol/l
- Low-density lipoprotein (LDL) cholesterol > 2.6 mmol/l
- Triglycerides > 1.7 mmol/l
- High-density lipoprotein (HDL) cholesterol ˂ 1.2 mmol/l in females, and ˂ 1 mmol/l in males.
- Body mass index (BMI) > 25 kg/m^2.
- Waist circumference of > 80 cm in women, and > 94 cm in men.
- Mediterranean diet score < 12
- Physically inactive.
- Current smoker or exposure to tobacco in any form.
Who cannot join
- Patients with symptomatic carotid stenosis and with a documented symptomatic cerebrovascular event. A cerebrovascular event is considered if the patient experienced any of an amaurosis fugax, transient ischaemic attack (TIA), or stroke within the past 6 months.
- Significant cognitive impairment or mental illness.
- Currently pregnant women (confirmed by β-Human chorionic gonadotropin (HCG) analysis).
- Inadequate English language ability to understand the content of the intervention programme.
- Involvement in another clinical trial in the previous six months.
- Legal incapacity.
Show all 9Show fewer
- Patient is bed-ridden or immobile.
- Contraindication to antiplatelet or anticoagulation therapy, or any of risk factor medications.
- Presence of any illness that could limit long-term compliance.
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Department of Vascular Surgery, Western Vascular Institute, Galway University Hospital
Galway
Sherif Sultan, MD, +35391542534, sherif.sultan@hse.ie
Wael Tawfick, MD, +35391542535, wael.tawfick@hse.ie
About this study
Official title: Intensive Lifestyle Modification Programme Versus Standard Care for Risk Factor Reduction and Stroke Prevention in Patients With Asymptomatic Carotid Artery Stenosis. A Prospective Randomised Controlled Trial
This study randomises patients with patients with asymptomatic carotid artery stenosis, to be managed either by providing an intensive 12-week lifestyle modification programme, or standard healthcare.
Read the detailed description
Cardiovascular disease (CVD) is the leading cause of mortality and acquired disability globally. According to the World Health Organisation (WHO), 30% of total global deaths are due to CVD, and approximately 6 million deaths result from cerebrovascular disease.
A common cause of cerebrovascular disease is internal carotid artery stenosis. Despite recent advances in carotid artery revascularisation, risk factor modification remains the cornerstone of therapy for this devastating disease. According to the European Society of Cardiology (ESC), the lifestyle risk factors for vascular diseases include; cigarette smoking, physical inactivity, increased body mass index, and unhealthy diet, and stress, while the medical risk factors include; High blood pressure, elevated blood sugar, and hyperlipidaemia. All these factors have been identified in several studies as significant modifiable risk factors that should be targeted for preventing morbidity and mortality resulting from cerebrovascular disease.
Previous studies indicated that modifiable risk factor programmes can help cardiac patients to achieve their risk factor modification targets. However, to date there do not seem to be any studies assessing the outcomes of a multidisciplinary risk factor modification programme in patients with carotid artery stenosis. Our study will evaluate the impact of an intensive 12-week, multidisciplinary risk factors modification programme on medical and lifestyle risk factors modification, as well as on risk reduction for stroke and cardiovascular events, among patients with asymptomatic carotid artery stenosis. We will compare these outcomes to that of standard care traditionally provided to this high-risk patient group.
- Conditions
- Carotid Stenosis
- Being tested
- Risk Factors Modification Programme, Standard Care
- Keywords
- Asymptomatic Carotid Artery Stenosis, Cardiovascular risk factors, Risk factor modification
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk Factors Modification ProgrammeBehavioural
12-week supervised risk factor modification programme derived from the EuroAction Study standards.
Standard CareBehavioural
Patients advised to adjust lifestyle without the support of the structured supervised programme.
| Study group | Role | What they receive |
|---|---|---|
| Risk Factors Modification Programme | Experimental | * Patients in the intervention arm will attend the 12-week intensive lifestyle programme which includes healthy lifestyle change such as smoking cessation, healthy food choices and increasing physical activity levels, as well as management of cholesterol, diabetes, and blood pressure.
* The 12-week programme will consist of 12 sessions of 2.5 hours each per week.
* Each of the weekly sessions will incorporate an individualised meeting between the multidisciplinary healthcare team and each patient to review the progress and health goals.
* The weekly sessions will also include a one-hour group exercise programme and an educational workshop. Receives: Behavioral: Risk Factors Modification Programme |
| Standard Care | Active comparator | Standard care is defined as giving information and advice to the patients to modify their lifestyles but without providing a structured intervention or an individualised plan. Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieve Lifestyle modification target
This is a composite primary endpoint. The patient will be considered to have achieved the composite primary endpoint if they achieve any one or more of the following targets:
- Smoking cessation.
- Body Mass Index (BMI) between 20 to 25 kg/m^2. BMI is calculated by dividing body weight in kilograms by the square of height in metres.
- Glycosylated Haemoglobin (HbA1C) less than 7%.
Measured: 12 weeks
Secondary outcomes (6)
Cardiovascular events
Any of cerebrovascular events (Transient ischaemic attack or stroke), myocardial infarction, or death.
Measured: 1 year
Changes in the degree of carotid artery stenosis
Any increase or decrease in the percentage of internal carotid artery stenosis, documented by duplex scan.
Measured: 1 year
Carotid artery revascularisation
Any need for carotid endarterectomy or carotid stenting, with any documented procedure complications.
Measured: 1 year
Re-intervention rates
Any re-intervention among patients who already underwent carotid revascularisation procedures.
Measured: 1 year
Change in cognitive function
Assessed using the Mini-Mental State Examination (MMSE) at enrolment and after one year.
The Mini-Mental State Examination (MMSE) is a validated 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment, patient's orientation, attention, memory, language, and visual-spatial skills.
The maximum score is 30 points (out of 30). Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. Moderate to low scores correlate closely with the presence of dementia. A version of the MMSE questionnaire can be found on the British Columbia Ministry of Health website.
Measured: 1 year
Change in quality of life
Assessed using the Dartmouth Cooperative Information Project (COOP) charts at enrolment and after one year.
The COOP charts measure six core aspects of functional status: physical fitness, feelings, daily activities, social activities, change in health, pain, and overall health. The instrument consists of six charts, referring to the above mentioned aspects of functioning. Each chart consists of a simple title, a question referring to the status of the patient and an ordinal five-point response scale illustrated with a simple drawing.
Each item is rated on this five-point ordinal scale ranging from 1 (no limitation at all) to 5 (severely limited); for 'change in health' score 1 means 'much better' and score 5 'much worse'. The designers do not advocate summing the responses to gain a single index figure of health status.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start1 Jun 2018
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomised, parallel group, active-control trial, with patients randomised in a 1:1 ratio to one of two treatment arms.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Vascular Institute, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wael Tawfick, MB BcH,MRCSI, Principal investigator, Western Vascular Institute, IrelandSherif Sultan, MD, FRCSI, Principal investigator, Western Vascular Institute, IrelandAbdelsalam BenSaaud, MB BcH, MSc, Study director, Western Vascular Institute, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929354
- Sponsor's protocol ID
- WVI-CAS
- Status last verified
- Jul 2021
- First submitted
- 19 Dec 2018
- Last updated
- 4 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) of primary and secondary outcomes, could be made available to other researchers by request, while maintaining participant confidentiality
Publications
Perk J, De Backer G, Gohlke H, Graham I, Reiner Z, Verschuren WM, Albus C, Benlian P, Boysen G, Cifkova R, Deaton C, Ebrahim S, Fisher M, Germano G, Hobbs R, Hoes A, Karadeniz S, Mezzani A, Prescott E, Ryden L, Scherer M, Syvanne M, Scholte Op Reimer WJ, Vrints C, Wood D, Zamorano JL, Zannad F; Comitato per Linee Guida Pratiche (CPG) dell'ESC. [European Guidelines on Cardiovascular Disease Prevention in Clinical Practice (version 2012). The Fifth Joint Task Force of the European Society of Cardiology and other societies on cardiovascular disease prevention in clinical practice (constituted by representatives of nine societies and by invited experts)]. G Ital Cardiol (Rome). 2013 May;14(5):328-92. doi: 10.1714/1264.13964. No abstract available. Italian.
PubMed 23612326Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corra U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Lochen ML, Lollgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WMM. [2016 European guidelines on cardiovascular disease prevention in clinical practice. The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts. Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation]. G Ital Cardiol (Rome). 2017 Jul-Aug;18(7):547-612. doi: 10.1714/2729.27821. No abstract available. Italian.
PubMed 28714997Kaikkonen JE, Mikkila V, Magnussen CG, Juonala M, Viikari JS, Raitakari OT. Does childhood nutrition influence adult cardiovascular disease risk?--insights from the Young Finns Study. Ann Med. 2013 Mar;45(2):120-8. doi: 10.3109/07853890.2012.671537. Epub 2012 Apr 12.
PubMed 22494087de Lorgeril M, Salen P, Martin JL, Monjaud I, Delaye J, Mamelle N. Mediterranean diet, traditional risk factors, and the rate of cardiovascular complications after myocardial infarction: final report of the Lyon Diet Heart Study. Circulation. 1999 Feb 16;99(6):779-85. doi: 10.1161/01.cir.99.6.779.
PubMed 9989963Iaccarino Idelson P, Scalfi L, Valerio G. Adherence to the Mediterranean Diet in children and adolescents: A systematic review. Nutr Metab Cardiovasc Dis. 2017 Apr;27(4):283-299. doi: 10.1016/j.numecd.2017.01.002. Epub 2017 Jan 12.
PubMed 28254269Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.
PubMed 15364185Wood DA, Kotseva K, Connolly S, Jennings C, Mead A, Jones J, Holden A, De Bacquer D, Collier T, De Backer G, Faergeman O; EUROACTION Study Group. Nurse-coordinated multidisciplinary, family-based cardiovascular disease prevention programme (EUROACTION) for patients with coronary heart disease and asymptomatic individuals at high risk of cardiovascular disease: a paired, cluster-randomised controlled trial. Lancet. 2008 Jun 14;371(9629):1999-2012. doi: 10.1016/S0140-6736(08)60868-5.
PubMed 18555911
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Lifestyle Modification Programme Versus Standard Care for Risk Factor Reduction and Stroke Prevention in Patients With Asymptomatic Carotid Artery Stenosis. A Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03929354
- Acronym / sponsor ID
- WVI-CAS
- Conditions
- Carotid Stenosis
- Keywords
- Asymptomatic Carotid Artery Stenosis, Cardiovascular risk factors, Risk factor modification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Western Vascular Institute, IrelandUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 26 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study randomises patients with patients with asymptomatic carotid artery stenosis, to be managed either by providing an intensive 12-week lifestyle modification programme, or standard healthcare.
Detailed description
Cardiovascular disease (CVD) is the leading cause of mortality and acquired disability globally. According to the World Health Organisation (WHO), 30% of total global deaths are due to CVD, and approximately 6 million deaths result from cerebrovascular disease.
A common cause of cerebrovascular disease is internal carotid artery stenosis. Despite recent advances in carotid artery revascularisation, risk factor modification remains the cornerstone of therapy for this devastating disease. According to the European Society of Cardiology (ESC), the lifestyle risk factors for vascular diseases include; cigarette smoking, physical inactivity, increased body mass index, and unhealthy diet, and stress, while the medical risk factors include; High blood pressure, elevated blood sugar, and hyperlipidaemia. All these factors have been identified in several studies as significant modifiable risk factors that should be targeted for preventing morbidity and mortality resulting from cerebrovascular disease.
Previous studies indicated that modifiable risk factor programmes can help cardiac patients to achieve their risk factor modification targets. However, to date there do not seem to be any studies assessing the outcomes of a multidisciplinary risk factor modification programme in patients with carotid artery stenosis. Our study will evaluate the impact of an intensive 12-week, multidisciplinary risk factors modification programme on medical and lifestyle risk factors modification, as well as on risk reduction for stroke and cardiovascular events, among patients with asymptomatic carotid artery stenosis. We will compare these outcomes to that of standard care traditionally provided to this high-risk patient group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomised, parallel group, active-control trial, with patients randomised in a 1:1 ratio to one of two treatment arms.
| Arm | Type | Receives |
|---|---|---|
| Risk Factors Modification Programme | Experimental | Behavioral: Risk Factors Modification Programme* Patients in the intervention arm will attend the 12-week intensive lifestyle programme which includes healthy lifestyle change such as smoking cessation, healthy food choices and increasing physical activity levels, as well as management of cholesterol, diabetes, and blood pressure. * The 12-week programme will consist of 12 sessions of 2.5 hours each per week. * Each of the weekly sessions will incorporate an individualised meeting between the multidisciplinary healthcare team and each patient to review the progress and health goals. * The weekly sessions will also include a one-hour group exercise programme and an educational workshop. |
| Standard Care | Active comparator | Behavioral: Standard CareStandard care is defined as giving information and advice to the patients to modify their lifestyles but without providing a structured intervention or an individualised plan. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Adults aged 18 years or more.
- Provide written informed consent.
- History of asymptomatic carotid artery stenosis, defined as a stenosis of the internal carotid artery of 50% or higher, but without history of any cerebrovascular events within the previous 6 months.
- Patients should have at least one of the following risk factors:
Key exclusion criteria (9 listed)
- Patients with symptomatic carotid stenosis and with a documented symptomatic cerebrovascular event. A cerebrovascular event is considered if the patient experienced any of an amaurosis fugax, transient ischaemic attack (TIA), or stroke within the past 6 months.
- Significant cognitive impairment or mental illness.
- Currently pregnant women (confirmed by β-Human chorionic gonadotropin (HCG) analysis).
- Inadequate English language ability to understand the content of the intervention programme.
- Involvement in another clinical trial in the previous six months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk Factors Modification Programme12-week supervised risk factor modification programme derived from the EuroAction Study standards. | Behavioural | Risk Factors Modification Programme |
| Standard CarePatients advised to adjust lifestyle without the support of the structured supervised programme. | Behavioural | Standard Care |
Primary outcome
Achieve Lifestyle modification target
Time frame: 12 weeks
This is a composite primary endpoint. The patient will be considered to have achieved the composite primary endpoint if they achieve any one or more of the following targets: 1. Smoking cessation. 2. Body Mass Index (BMI) between 20 to 25 kg/m^2. BMI is calculated by dividing body weight in kilograms by the square of height in metres. 3. Glycosylated Haemoglobin (HbA1C) less than 7%.
6 secondary outcomes
Cardiovascular events
Time frame: 1 year
Changes in the degree of carotid artery stenosis
Time frame: 1 year
Carotid artery revascularisation
Time frame: 1 year
Re-intervention rates
Time frame: 1 year
Change in cognitive function
Time frame: 1 year
Change in quality of life
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Background: PubMed 23612326Perk J, De Backer G, Gohlke H, Graham I, Reiner Z, Verschuren WM, Albus C, Benlian P, Boysen G, Cifkova R, Deaton C, Ebrahim S, Fisher M, Germano G, Hobbs R, Hoes A, Karadeniz S, Mezzani A, Prescott E, Ryden L, Scherer M, Syvanne M, Scholte Op Reimer WJ, Vrints C, Wood D, Zamorano JL, Zannad F; Comitato per Linee Guida Pratiche (CPG) dell'ESC. [European Guidelines on Cardiovascular Disease Prevention in Clinical Practice (version 2012). The Fifth Joint Task Force of the European Society of Cardiology and other societies on cardiovascular disease prevention in clinical practice (constituted by representatives of nine societies and by invited experts)]. G Ital Cardiol (Rome). 2013 May;14(5):328-92. doi: 10.1714/1264.13964. No abstract available. Italian.
- Background: PubMed 28714997Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corra U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Lochen ML, Lollgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WMM. [2016 European guidelines on cardiovascular disease prevention in clinical practice. The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts. Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation]. G Ital Cardiol (Rome). 2017 Jul-Aug;18(7):547-612. doi: 10.1714/2729.27821. No abstract available. Italian.
- Background: PubMed 22494087Kaikkonen JE, Mikkila V, Magnussen CG, Juonala M, Viikari JS, Raitakari OT. Does childhood nutrition influence adult cardiovascular disease risk?--insights from the Young Finns Study. Ann Med. 2013 Mar;45(2):120-8. doi: 10.3109/07853890.2012.671537. Epub 2012 Apr 12.
- Background: PubMed 9989963de Lorgeril M, Salen P, Martin JL, Monjaud I, Delaye J, Mamelle N. Mediterranean diet, traditional risk factors, and the rate of cardiovascular complications after myocardial infarction: final report of the Lyon Diet Heart Study. Circulation. 1999 Feb 16;99(6):779-85. doi: 10.1161/01.cir.99.6.779.
- Background: PubMed 28254269Iaccarino Idelson P, Scalfi L, Valerio G. Adherence to the Mediterranean Diet in children and adolescents: A systematic review. Nutr Metab Cardiovasc Dis. 2017 Apr;27(4):283-299. doi: 10.1016/j.numecd.2017.01.002. Epub 2017 Jan 12.
- Background: PubMed 15364185Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.
- Background: PubMed 18555911Wood DA, Kotseva K, Connolly S, Jennings C, Mead A, Jones J, Holden A, De Bacquer D, Collier T, De Backer G, Faergeman O; EUROACTION Study Group. Nurse-coordinated multidisciplinary, family-based cardiovascular disease prevention programme (EUROACTION) for patients with coronary heart disease and asymptomatic individuals at high risk of cardiovascular disease: a paired, cluster-randomised controlled trial. Lancet. 2008 Jun 14;371(9629):1999-2012. doi: 10.1016/S0140-6736(08)60868-5.
- Individual participant dataSharing planned: No. Individual participant data (IPD) of primary and secondary outcomes, could be made available to other researchers by request, while maintaining participant confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wael Tawfick, MB BcH,MRCSI principal investigator
Western Vascular Institute, Ireland
Sherif Sultan, MD, FRCSI principal investigator
Western Vascular Institute, Ireland
Abdelsalam BenSaaud, MB BcH, MSc study director
Western Vascular Institute, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk Factors Modification Programme in people with Carotid Stenosis, run by Western Vascular Institute, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wael Tawfick, MB BcH,MRCSI (+ 35391542535, wael.tawfick@hse.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achieve Lifestyle modification target (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03929354, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.