NCT01197677已完成不适用
European Cardiovascular Magnetic Resonance Registry
Stiftung Institut fuer Herzinfarktforschung10 个研究点 分布在 4 个国家目标入组 30,000 人开始时间: 2009年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30,000
- 试验地点
- 10
- 主要终点
- collect data from a large number of patients regarding the general use of CMR in European clinical practice, its safety and its therapeutic implications
研究概览
简要总结
- The main aim of the first specific protocol initiated by the European CMR registry, suspected CAD, is to demonstrate that patients presenting for work up of suspected coronary artery disease, which have a completely normal CMR scan will have a low risk for cardiovascular events.
- The main aim of the second specific protocol initiated by the European CMR registry, HCM-SCD, will be to evaluate CMR for risk stratification in hypertrophic cardiomyopathy(HCM).
- This registry is sought to collect data on the general use of CMR in the European clinical practice, its safety and its therapeutic implications in a high number of cases to 1) substantiate the clinical yield of CMR and 2) to define additional clinical questions worth to be investigated in detail as additional specific protocols in the future.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •European clinical practice: Consecutive patients with accomplished CMR.
- •Suspected-CAD: Consecutive patients with suspected coronary artery disease undergoing a combined CMR protocol including evaluation of LV function, assessment of myocardial ische¬mia by adenosine stress perfusion or high-dose dobutamine CMR and detection of myocardial infarction using contrast-enhanced CMR.
- •HCM-SCD: Consecutive patients with hypertrophic cardiomyopathy undergoing a combined CMR protocol including LV function, rest perfusion, and detection of myocardial scarring by contrast-enhanced CMR. The diagnosis of hypertrophic cardiomyopathy is based on the demonstration of a hypertrophied, non-dilated left ventricle (wall thickness of at least 15 mm in adults or the equivalent relative to body-surface area in children) in the absence of another cardiac or systemic disease capable of producing a similar degree of hypertrophy. In adult relatives of the patients with hypertrophic cardiomyo¬pathy, a wall thickness of 13 mm or more will be considered a criterion for diagnosis.
排除标准
- •European clinical practice: None
- •Suspected-CAD: Missing informed consent. Patients with known CAD by invasive coronary angiography or previous MI.
- •HCM-SCD: Missing informed consent. Patients with known CAD by invasive coronary angiography or previous MI. Patients with left ventricular hypertrophy of other causes (e.g. hypertension, valvular heart disease)
结局指标
主要结局
collect data from a large number of patients regarding the general use of CMR in European clinical practice, its safety and its therapeutic implications
时间窗: 01/01/2009-
次要结局
- to show that a normal CMR protocol (incl. LV wall motion at rest, stress ischemia, and scar detection) predicts a low risk of future cardiovascular events.(01/01/2009)
- to evaluate if myocardial scarring assessed by contrast-enhanced CMR is a stronger predictor of adverse events during follow up than the general clinical markers of an adverse long term outcome in HCM.(01/01/2009-)
研究者
研究点 (10)
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