Lifestyle Modification Programme for Patients With Asymptomatic Carotid Artery Stenosis

NCT03929354 | Unknown

• 1 other identifier: WVI-CAS
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carotid Stenosis

Keywords

Asymptomatic Carotid Artery Stenosis; Cardiovascular risk factors; Risk factor modification

Outcome Measures

Primary Outcomes (1)

• 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: 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%.

  12 weeks

Secondary Outcomes (6)

• Cardiovascular events

  1 year

• Changes in the degree of carotid artery stenosis

  1 year

• Carotid artery revascularisation

  1 year

• Re-intervention rates

  1 year

• Change in cognitive function

  1 year

Study Arms (2)

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.

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.

Behavioral: Standard Care

Interventions

Risk Factors Modification Programme BEHAVIORAL

12-week supervised risk factor modification programme derived from the EuroAction Study standards.

Risk Factors Modification Programme

Standard Care BEHAVIORAL

Patients advised to adjust lifestyle without the support of the structured supervised programme.

Standard Care

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Western Vascular Institute, Ireland: lead

Study Sites (1)

Department of Vascular Surgery, Western Vascular Institute, Galway University Hospital

Galway, Ireland

RECRUITING

Related Publications (7)

• 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.

  PMID: 23612326 BACKGROUND

• 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.

  PMID: 28714997 BACKGROUND

• 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.

  PMID: 22494087 BACKGROUND

• 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.

  PMID: 9989963 BACKGROUND

• 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.

  PMID: 28254269 BACKGROUND

• 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.

  PMID: 15364185 BACKGROUND

• 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.

  PMID: 18555911 BACKGROUND

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Wael Tawfick, MB BcH,MRCSI

  Western Vascular Institute, Ireland

  PRINCIPAL INVESTIGATOR

• Sherif Sultan, MD, FRCSI

  Western Vascular Institute, Ireland

  PRINCIPAL INVESTIGATOR

• Abdelsalam BenSaaud, MB BcH, MSc

  Western Vascular Institute, Ireland

  STUDY DIRECTOR

Central Study Contacts

Wael Tawfick, MB BcH,MRCSI

CONTACT

+ 35391542535; wael.tawfick@hse.ie

Sherif Sultan, MD, FRCSI

CONTACT

+35391542534; sherif.sultan@hse.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding of trial participants and care providers is not possible because of obvious differences between the interventions. However, the investigator, the outcomes assessor and statistician are blinded to treatment received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomised, parallel group, active-control trial, with patients randomised in a 1:1 ratio to one of two treatment arms.

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: April 26, 2019
• Study Start: June 1, 2018
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)