Intima-Medial Thickness Guidance of Primary Prevention in Relatives of Patients With Early onSet Atherosclerosis: The IMPRESS Study- A Multi-centre, Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 1,310
- 试验地点
- 6
- 主要终点
- Change in CIMT from baseline to three years
研究概览
简要总结
The primary objective of this study is, to instigate a reduction in atherosclerotic burden within the carotid arteries in the intervention group compared to the control group and to demonstrate parallel improvements in cardiovascular and overall health status relative to usual care
详细描述
Individuals at intermediate risk account for a large proportion of patients presenting with atherosclerotic events. The barriers to reducing this problem relate to the expense of an unselective primary prevention strategy among a group where the majority will not have events, as well as the difficulty of getting apparently well subjects to adhere to lifestyle and pharmacologic management.
An outcome-based study would require large numbers and would be unlikely to be funded without proof of concept. CIMT will be used as a validated surrogate of atherosclerotic status and future cardiovascular events in this study.
As such, this study will use CIMT (as both a delineator of risk and in the primary endpoint), a marker of atherosclerotic burden (the disease process rather than a surrogate), to address the unresolved issue about how to most efficiently manage intermediate risk subjects with a family history of premature atherosclerosis by combining better selection of such individuals for active treatment and recommended lifestyle changes with a DMP strategy to optimise their successful application in the longer-term.
The Intima-Media thickness guidance of Primary prevention in Relatives of individuals with Early onSet atherosclerosiS (IMPRESS) Study will test the following null hypothesis:
In intermediate risk, first-degree relatives (i.e. mother, father, brother or sister) of individuals with premature atherosclerosis, a CIMT-targeted DMP for primary prevention (the IMPRESS intervention) incorporating more intensive non-pharmacological and pharmacological management, provides no better reduction of atherosclerotic burden (as determined by the change in CIMT from baseline to follow-up completion) than usual health care management during three years follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a first-degree relative (i.e. a mother, father, brother or sister) with premature (onset <65 years of age) atherosclerosis. This includes coronary artery disease/acute myocardial infarction, non-haemorrhagic stroke and peripheral vascular disease.
- •Are classified as "intermediate risk" of experiencing a cardiovascular event in the next 5 years as determined via the Framingham Risk Equation 7, 22
- •Live within a geographically accessible area for follow-up (i.e. within a 40km radius of the study centre)
- •Are living independently in the community or their own home
- •Are able and willing to provide written informed consent to participate in the study (this includes the ability to understand and speak English fluently and that the patient is mentally competent)
排除标准
- •Pre-existing atherosclerotic disease
- •Have been diagnosed with Type 1 or Type 2 Diabetes Mellitus
- •Have contraindications to the use of statin medications (includes pregnancy and breastfeeding)
- •Unable to provide written informed consent to participate in this study
- •Have a terminal malignancy requiring palliative care, or limited life expectancy or any other medical condition (including pregnancy) that results in the belief (deemed by the Chief Investigators) that it is not appropriate for the patient to participate in this trial
- •Participating in another clinical research trial
结局指标
主要结局
Change in CIMT from baseline to three years
时间窗: 3 years
CIMT will be used as a validated surrogate of atherosclerotic status and future cardiovascular events in this study. As such, this study will use CIMT (as both a delineator of risk and in the primary endpoint), a marker of atherosclerotic burden (the disease process rather than a surrogate), to address the unresolved issue about how to most efficiently manage intermediate risk subjects with a family history of premature atherosclerosis
次要结局
- i) Plaque length (carotid artery) ii) Internal CIMT iii) General health and well being iv) Mental health v) Health care costs vi) Modifiable risk factors(3 years)