Early Detection of Silent Myocardial Ischemia and Cardiac Dysfunction in Asymptomatic Individuals With Increased Coronary Artery Calcium Scores
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Rate of major adverse cardiac events
研究概览
简要总结
Early-Synergy investigates a diagnostic imaging approach in asymptomatic individuals from the general population for early detection of silent myocardial ischemia and cardiac dysfunction. The diagnostic imaging approach consists of cardiac computed tomography for coronary artery calcium scoring (CT-CAC) and cardiac magnetic resonance (CMR) stress perfusion imaging. Early-Synergy investigates the effect of early detection of silent myocardial ischemia and cardiac dysfunction by CMR in asymptomatic individuals with increased CAC. In addition, the diagnostic yield of CMR for early detection of silent myocardial ischemia and cardiac dysfunction is investigated. Asymptomatic individuals at increased risk (CAC ≥ 300) are therefore randomized 1:1 to either CMR stress perfusion imaging or a control group.
详细描述
Early-Synergy is a prospective multi-center study performed in the Netherlands. Potential candidates for participation in Early-Synergy have had CT-CAC scanning as part of participation in two ongoing population-based studies (ROBINSCA and ImaLife) and had CAC ≥300.
Participants are randomized in a 1:1 fashion to (1.) CMR stress perfusion imaging with feedback of clinically actionable findings or (2.) control group.
In the CMR group, feedback on CMR stress perfusion imaging is provided to the participant and general practitioner only in case of CMR findings that require further management based on current clinical guidelines. Participants in the control group will not receive stress CMR perfusion imaging but will be followed in time to evaluate the clinical presentation of the natural course of coronary atherosclerosis.
Follow-up will be performed up to 5 years in both groups by sending questionnaires and collecting medical information from health care providers and registries. Additionally, blood is drawn from participants in the CMR group during the hospital visit for CMR scanning and is stored to allow evaluation of cardiac blood markers as predictors of CMR findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participation in ROBINSCA or ImaLife study
- •CT-CAC ≥300
排除标准
- •History of ischemic heart disease or other cardiac disease (myocardial infarction, sudden cardiac arrest, heart failure, cardiomyopathy, congenital cardiac disease, percutaneous coronary intervention, coronary artery bypass grafting surgery, valvular surgery, other major cardiac surgery (e.g. cardiac transplantation) and/or previous invasive coronary angiography or catheter ablation)
- •Contra-indication for stress CMR perfusion imaging (claustrophobia, CMR incompatible device (e.g., Implantable Cardioverter Defibrillator/pacemaker), contrast agent or vasodilator intolerance, contra-indications for adenosine or regadenoson (e.g. 2nd/3rd degree atrioventricular block, severe hypotension) and/or weight > 125 kg)
- •Severe comorbidity and/or a life expectancy of less than 1 year
- •Unable to provide written informed consent
- •Pregnancy
研究组 & 干预措施
Cardiac magnetic resonance imaging
Cardiac magnetic resonance (CMR) stress perfusion imaging with feedback of clinically actionable findings
干预措施: CMR stress perfusion imaging (Diagnostic Test)
Control
No intervention, following the natural course of coronary atherosclerosis
结局指标
主要结局
Rate of major adverse cardiac events
时间窗: 5 years
Cardiovascular death, non-fatal myocardial infarction or hospitalization for unstable angina, heart failure or resuscitated cardiac arrest
Diagnostic yield of CMR stress perfusion imaging
时间窗: Baseline
Prevalence and extent of silent myocardial ischemia and cardiac dysfunction
Rate of major adverse cardiac events
时间窗: 1 year
Cardiovascular death, non-fatal myocardial infarction or hospitalization for unstable angina, heart failure or resuscitated cardiac arrest
Rate of major adverse cardiac events
时间窗: 2.5 years
Cardiovascular death, non-fatal myocardial infarction or hospitalization for unstable angina, heart failure or resuscitated cardiac arrest
次要结局
- Rate of individual components of primary outcome 1(5 years)
- All-cause mortality rate(5 years)
- Rate of medical therapy initiation(5 years)
- Quality of Life as reflected by EQ-5D-5S score(5 years)
- Quality of Life as reflected by HeartQoL score(5 years)
- Rate of invasive cardiovascular procedures(5 years)
- Rate of hospitalization for cardiovascular disease(2.5 years)
- Rate of non-invasive cardiac imaging procedures(5 years)
- Rate of individual components of primary outcome 1(1 year)
- Rate of individual components of primary outcome 1(2.5 years)
- All-cause mortality rate(1 year)
- All-cause mortality rate(2.5 years)
- Rate of invasive cardiovascular procedures(1 year)
- Rate of invasive cardiovascular procedures(2.5 years)
- Rate of hospitalization for cardiovascular disease(1, 2.5, 5 years)
- Rate of hospitalization for cardiovascular disease(1 year)
- Rate of medical therapy initiation(1 year)
- Rate of medical therapy initiation(2.5 years)
- Quality of Life as reflected by EQ-5D-5S score(1 year)
- Quality of Life as reflected by EQ-5D-5S score(2.5 years)
- Quality of Life as reflected by HeartQoL score(1 year)
- Quality of Life as reflected by HeartQoL score(2.5 years)
研究者
Pim van der Harst
Clinical professor, Principal Investigator
University Medical Center Groningen