Lifestyle Modification Programme for Patients With Asymptomatic Carotid Artery Stenosis

August 3, 2021 updated by: Western Vascular Institute, Ireland

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Galway, Ireland
        • Recruiting
        • Department of Vascular Surgery, Western Vascular Institute, Galway University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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:

    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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Risk Factors Modification Programme
12-week supervised risk factor modification programme derived from the EuroAction Study standards.
Active Comparator: 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.
Behavioral: Standard Care
Patients advised to adjust lifestyle without the support of the structured supervised programme.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular events
Time Frame: 1 year
Any of cerebrovascular events (Transient ischaemic attack or stroke), myocardial infarction, or death.
1 year
Changes in the degree of carotid artery stenosis
Time Frame: 1 year
Any increase or decrease in the percentage of internal carotid artery stenosis, documented by duplex scan.
1 year
Carotid artery revascularisation
Time Frame: 1 year
Any need for carotid endarterectomy or carotid stenting, with any documented procedure complications.
1 year
Re-intervention rates
Time Frame: 1 year
Any re-intervention among patients who already underwent carotid revascularisation procedures.
1 year
Change in cognitive function
Time Frame: 1 year

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.
1 year
Change in quality of life
Time Frame: 1 year

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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Vascular Institute, Ireland

Investigators

  • Principal Investigator: Sherif Sultan, MD, FRCSI, Western Vascular Institute, Ireland
  • Study Director: Abdelsalam BenSaaud, MB BcH, MSc, Western Vascular Institute, Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

December 19, 2018

First Submitted That Met QC Criteria

April 23, 2019

First Posted (Actual)

April 26, 2019

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WVI-CAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) of primary and secondary outcomes, could be made available to other researchers by request, while maintaining participant confidentiality

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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