A Prospective Clinical Trial to Evaluate the Clinical Value and Cost-effectiveness of a Personalized Prevention Program in Patients With High Risk Stable Coronary Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12,000
- 试验地点
- 26
- 主要终点
- To demonstrate whether a PPP strategy in high-risk CHD subjects results in a decreased risk of CV events (CV death, nonfatal MI or HF events) compared to the UC
研究概览
简要总结
Prospective clinical study with two parts:
PART A: a prospective biomarker-based risk screening study in coronary heart disease (CHD) subjects PART B: a nested randomized clinical trial (RCT) in an enriched subpopulation of high-risk stable CHD subjects
PART A: 12 000 subjects with stable CHD
PART B: 2000 subjects with high risk of CV events will be randomized to usual care (UC) or personalised prevention program (PPP) i.e. 1000 subjects per arm.
Study purpose is to assess the clinical value and cost-effectiveness of a personalised prevention program (PPP) in high-risk, stable coronary heart disease (CHD) subjects and to prospectively validate risk screening biomarkers
详细描述
Primary Objectives:
PART A:
- To prospectively validate biomarkers in risk stratification among stable CHD subjects, i.e. evaluation of the biomarker performance in accurately predicting CV events including CV death, nonfatal MI, HF events
- To identify high-risk CHD subjects for the subsequent RCT, i.e. 15-20% of the screened patient population at the highest risk
PART B
• To demonstrate whether a personalised prevention (PPP) strategy in high-risk CHD subjects results in a decreased risk of cardiovascular (CV) events (CV death, nonfatal myocardial infarction (MI) or heart failure (HF) events) as compared to the local usual care (UC)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible study subjects must meet all of the following inclusion criteria:
- •Informed consent form signed by the study subjects.
- •Male or female aged 30 to 80 years on the day of enrolment.
- •> 50% stenosis in one or more major coronary arteries on angiography or computerised tomography (CT) performed within the preceding one year (from enrolment visit).
- •or Myocardial infarction (type I, II) during the preceding year.
- •Eligible study subjects must not meet any of the following
排除标准
- •Hospitalisation for acute coronary syndrome, myocardial infarction, stroke, coronary revascularisation or acute heart failure within the preceding one month (30 days). These subjects can be enrolled after a one-month stabilisation period, which begins from the time of the event.
- •Subjects with NYHA class III-IV heart failure i.e. marked limitation in activity due to symptoms, comfortable only at rest.
- •Uncontrolled arrhythmias such as ventricular tachycardias.
- •Subjects undergoing dialysis due to severe renal disease.
- •Diseases that severely disable exercising (per investigator's judgement), such as rheumatoid arthritis, neurological or orthopaedic diseases.
- •Known aplastic or haemolytic anaemia.
- •Concomitant non-coronary disease, such as malignancy that limits life expectancy to less than three years.
- •Concurrent participation in another interventional study.
- •Subjects not able and/or willing to attend all scheduled visits and comply with all study procedures and use a smartphone application.
研究组 & 干预措施
Personalised prevention program (PPP)
Participants will be invited to return to the study site six times over a three year period to receive lifestyle coaching and exercise prescriptions. Eupropean Society of Cardiology/European Association of Preventive Cardiology (ESC/EAPC) -designed lifestyle counselling will be partially delivered by novel smartphone applications. Participants will also receive pharmaceutical treatment according to the ESC guideline for chronic coronary syndromes.
干预措施: personalised prevention program (PPP) (Behavioral)
Usual care (UC)
Participants will be referred back to usual care provided by their treating physicians. It is anticipated that physicians will treat these participants according to local usual medical practices. Patients randomized to UC group will not receive any treatment recommendations nor restrictions by the study investigators or nurses.
Randomized UC patients are invited to site visits twice over a three year period.
结局指标
主要结局
To demonstrate whether a PPP strategy in high-risk CHD subjects results in a decreased risk of CV events (CV death, nonfatal MI or HF events) compared to the UC
时间窗: 3 years follow-up
• The time from randomisation to the occurrence of the first CV event included in the composite endpoint of the study (CV death, nonfatal MI, HF events) over 3 years follow-up.
次要结局
- To evaluate the difference between PPP arm to the UC arm in(3 years follow-up)
- To evaluate the health economic value of the PPP(3 years follow-up)
- • To prospectively study associations (in all enrolled subjects) between separate risk biomarkers (CERT2, hs-troponin , proBNP, Cystatin C) or their score (CoroPredict) and(3 years follow-up)
研究者
Reijo Laaksonen
Project Director
Tampere University