Lifestyle Modification Programme for Patients With Asymptomatic Carotid Artery Stenosis

Western Vascular Institute, Ireland

Status: Unknown

Conditions: Carotid Stenosis

Treatments: Behavioral: Risk Factors Modification Programme; Behavioral: Standard Care

Study type: Interventional

Funder types: Other

Identifiers

NCT03929354

WVI-CAS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 208 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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208 participants in 2 patient groups

Risk Factors Modification Programme

Experimental group

Description:

* 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.

Treatment:

Behavioral: Risk Factors Modification Programme

Standard Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard Care