A Prospective, Observational Study to Assess the Efficacy of New Quantitative Imaging Methods to Assess the Risk of Acute and Subacute Thromboembolic Complications of Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Combined binary variable consisting of one of the following: ventricular thrombosis assessed by cardiac MRI, silent brain infarct detected by brain MRI, peripheral acute arterial embolism or ischemic stroke within the 6 months after a first STEMI
研究概览
简要总结
This project aims to assess the ability of cardiac imaging (cardiac MRI and Doppler-echocardiography) post-processing tools to predict a combined end-point of intraventricular thrombosis, silent brain infarcts, clinical stroke and peripheral arterial embolism in patients with first acute myocardial infarction and ventricular dysfunction.
详细描述
An acute myocardial infarction (AMI) is a clinical situation that entails an increased risk of both subclinical and clinically devastating cardioembolic events. This increased risk of embolic phenomena may be related to blood stasis caused by alterations in the blood flow inside the left ventricle (LV) after AMI. Using flow velocity measurements obtained by cardiac MRI and Doppler-echocardiography it is possible to quantify the stasis in the LV and assess its relation to the risk of embolic events. The ability of cardiac imaging (cardiac MRI and Doppler-echocardiography) post-processing tools to predict embolic events in a cohort of 92 patients with a first AMI and left ventricular dysfunction shall be addressed. The potential confusion generated by the possible existence of paroxysmal AF will be controlled by implanting cardiac monitoring devices in random order in a subset of patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •First ST elevation AMI undergoing (or not) revascularization.
- •Sinus rhythm in the first 24 hours of the AMI.
- •Written informed consent. ( 4) Left ventricular ejection fraction < 45% measured by echocardiography in the first 24-72 hours after AMI symptoms onset.
排除标准
- •Implantable defibrillation or stimulation devices not compatible with MRI.
- •Killip-IV class or other shock situations or marked peripheral hypoperfusion.
- •Aborted sudden death or other causes of possible acute brain damage attributed to cerebral hypoperfusion.
- •Hemodynamically significant valvular disease or prosthetic heart valves.
- •Claustrophobia that impedes MRI scanning.
- •Atrial fibrillation (AF) in the first 24 hours after AMI.
- •Carotid Artery Disease diagnosed with stenosis greater than 50%.
- •Full oral anticoagulation prior to admission or indication of anticoagulation.
- •Defined pro-thrombotic conditions.
- •History of previous stroke in the last 6 months.
结局指标
主要结局
Combined binary variable consisting of one of the following: ventricular thrombosis assessed by cardiac MRI, silent brain infarct detected by brain MRI, peripheral acute arterial embolism or ischemic stroke within the 6 months after a first STEMI
时间窗: 6 months
Individual outcome measurements as described in Secondary Outcome Measures Section
次要结局
- Silent brain infarcts (SBI) within the 6 months following a first STEMI(6 months)
- Ischemic stroke within the 6 months after STEMI(6 months)
- Left ventricle mural thrombosis assessed by cardiac MRI performed one week and 6 months after STEMI(6 months)
- Peripheral acute arterial embolism (limb or visceral) within the 6 months following a first STEMI(6 months)
- High Intensity Transient Signals (HITs) detected by transcranial Doppler monitoring of both middle cerebral arteries during 30 minutes within the 24-72 hours after STEMI(24-72 hours)
- Neuropsychiatric and cognitive impact of SBIs within the 6 months after STEMI assessed by Beck and Minimental questionnaire(6 months)
研究者
Javier Bermejo Thomas
Non-invasive Cardiology Section Chief, Department of Cardiology
Hospital General Universitario Gregorio Marañon