NCT03929354

Lifestyle Modification Programme for Patients With Asymptomatic Carotid Artery Stenosis

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 208 (estimated)
• Sponsor: Western Vascular Institute, Ireland · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Carotid Stenosis

Interventions

Type	Name	Description
BEHAVIORAL	Risk Factors Modification Programme	12-week supervised risk factor modification programme derived from the EuroAction Study standards.
BEHAVIORAL	Standard Care	Patients advised to adjust lifestyle without the support of the structured supervised programme.

Timeline

• Start date: 2018-06-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2019-04-26
• Last updated: 2021-08-04

Locations

1 site across 1 country: Ireland