Stockholm Myocardial Infarction With Normal Coronaries (SMINC)-2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of an early CMR with the latest technique
研究概览
简要总结
Myocardial infarction with angiographically normal coronary arteries (MINCA) is common (7-8 % of all myocardial infarctions). There are several different causes behind MINCA where "true infarction" due to thromboembolism, myocarditis or Takotsubo stress cardiomyopathy are the main findings. The underlying diagnosis is often made by clinical findings sometimes with the help of cardiac MRI (CMR). Investigators have previously shown that it was possible to give 50 % of the patients a diagnosis made by the combination of clinical findings and CMR made in median 12 days after the acute event. The present study aim at improve the diagnostic accuracy by an early CMR with latest technique.
详细描述
The present study aim at improve the diagnostic accuracy in MINCA with an CMR made 2-4 days after the acute event. The aim is to give 70 % of all patients with MINCA (35-70 years old) a definitive diagnosis made by CMR only. One-hundred and fifty patients will be included and compared with a similar historical sample where 50 % of the patients received a diagnosis made by a late CMR and clinical findings. The study has 80 % power to detect this 20 % absolute difference (p <0.05).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 35 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •35-70 years
- •Fullfill the diagnosic criteria of myocardial infarction
- •Normal coronary angiography or minor atheromatosis
- •Sinus rythm on ECG at admission
排除标准
- •Previous myocardial infarction
- •Known cardiomyopathy
- •Pacemaker or claustrophobia
- •Severe chronic obstructive lung or kidney disease
- •Pulmonary embolism
研究组 & 干预措施
Prospective MINCA patients
Patients with MINCA prospectively investigated with an early CMR with latest technique
干预措施: CMR (Procedure)
Historical MINCA patients
Patients with MINCA investigated earlier with a late CMR (median 12 days)
干预措施: CMR (Procedure)
结局指标
主要结局
Diagnostic accuracy of an early CMR with the latest technique
时间窗: 2-4 days after admission
Show that the more patients get a definite diagnosis (70%) when compared to a historical sample (50%)
次要结局
- Number of patients with correct diagnosis with echocardiography(12 months)
- Describe QoL over time(12 months)
- Number of patients with a postive CT angiography and infarction on CMR(1 month)
研究者
Per Tornvall
Associate professor
Karolinska Institutet