Lifestyle Modification Programme for Patients With Asymptomatic Carotid Artery Stenosis
NCT ID: NCT03929354
Last Updated: 2021-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
208 participants
INTERVENTIONAL
2018-06-01
2022-09-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Risk Factors Modification Programme
12-week supervised risk factor modification programme derived from the EuroAction Study standards.
Standard Care
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.
Standard Care
Patients advised to adjust lifestyle without the support of the structured supervised programme.
Interventions
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Risk Factors Modification Programme
12-week supervised risk factor modification programme derived from the EuroAction Study standards.
Standard Care
Patients advised to adjust lifestyle without the support of the structured supervised programme.
Eligibility Criteria
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Inclusion Criteria
* 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:
1. Blood pressure \> 140/80 mmHg
2. Fasting blood sugar \> 53 mmol/mol (HbA1c \> 7%)
3. Total cholesterol \> 5 mmol/l
4. Low-density lipoprotein (LDL) cholesterol \> 2.6 mmol/l
5. Triglycerides \> 1.7 mmol/l
6. High-density lipoprotein (HDL) cholesterol ˂ 1.2 mmol/l in females, and ˂ 1 mmol/l in males.
7. Body mass index (BMI) \> 25 kg/m\^2.
8. Waist circumference of \> 80 cm in women, and \> 94 cm in men.
9. Mediterranean diet score \< 12
10. Physically inactive.
11. Current smoker or exposure to tobacco in any form.
Exclusion Criteria
* 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.
* 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.
18 Years
100 Years
ALL
No
Sponsors
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Western Vascular Institute, Ireland
OTHER
Responsible Party
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Principal Investigators
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Wael Tawfick, MB BcH,MRCSI
Role: PRINCIPAL_INVESTIGATOR
Western Vascular Institute, Ireland
Sherif Sultan, MD, FRCSI
Role: PRINCIPAL_INVESTIGATOR
Western Vascular Institute, Ireland
Abdelsalam BenSaaud, MB BcH, MSc
Role: STUDY_DIRECTOR
Western Vascular Institute, Ireland
Locations
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Department of Vascular Surgery, Western Vascular Institute, Galway University Hospital
Galway, , Ireland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Piepoli 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.
Kaikkonen 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.
de 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.
Iaccarino 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.
Yusuf 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.
Wood 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.
Other Identifiers
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WVI-CAS
Identifier Type: -
Identifier Source: org_study_id
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