Lifestyle Modification Programme for Patients With Asymptomatic Carotid Artery Stenosis
Carotid Stenosis
About this trial
This is an interventional treatment trial for Carotid Stenosis focused on measuring Asymptomatic Carotid Artery Stenosis, Cardiovascular risk factors, Risk factor modification
Eligibility Criteria
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:
- 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.
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.
Sites / Locations
- Department of Vascular Surgery, Western Vascular Institute, Galway University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Risk Factors Modification Programme
Standard Care
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 is defined as giving information and advice to the patients to modify their lifestyles but without providing a structured intervention or an individualised plan.