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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Achieve Lifestyle modification target
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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^
- •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.
排除标准
- •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.
结局指标
主要结局
Achieve Lifestyle modification target
时间窗: 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%.
次要结局
- Re-intervention rates(1 year)
- Change in quality of life(1 year)
- Cardiovascular events(1 year)
- Changes in the degree of carotid artery stenosis(1 year)
- Carotid artery revascularisation(1 year)
- Change in cognitive function(1 year)