Multimodal IMAgery (Echocardiography and Cardiac MRI) Characterization of Cardiac Damage and Severity After COVID-19 Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To Characterize cardiac involvement by cardiac MRI during 4 months after confirmed COVID-19 infection
研究概览
简要总结
Coronavirus Disease 2019 (COVID-19) is an infection caused by Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2), which affects multiple organ system particularly the lung and heart. Indeed, SARS CoV-2 has various cardiac manifestations which are associated with higher mortality and morbidity. Cardiac involvement, based on elevated levels of myocardial enzymes, have been described in 20 to 30% of COVID-19 infection. However, the physiopathological mechanisms of myocardial injury remains unclear. Main hypothesis include inflammation and cytokine storm, hypercoagulability and vascular thrombosis, inflammation or stress leading to coronary plaque rupture (type I myocardial infarction), supply-demand mismatch and hypoxemia resulting in myocardial damage (type II myocardial infarction) ...
Two patterns can be identified : ischemic or non-ischemic pattern including myocarditis, stress induced cardiomyopathy, thrombo-embolic disease. However, the consequences of myocardial damage after confirmed COVID-19 infection are unknown at medium to long term prognosis.
Data are needed to identify myocardial damage and to guide effective therapies and follow-up (use of ACE inhibitor, beta-blockers, steroids...? ) In this study, the investigators proposed to collect multimodal cardiac imaging including MRI (Magnetic Resonance Imaging) and TTE (Transthoracic echocardiogram) in order to identify and characterize cardiac injury as ischemic or non-ischemic pattern, to better assess risk stratification and to guide effective therapies if necessary.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 79 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiac involvement confirmed : increase troponin level > 50pg/ml or left ventricular dysfunction assessed by echocardiography during hospitalization for confirmed COVID-19 infection
- •Absence of severe renal failure (CKD EPI > 30ml/min/1.73m²)
- •Cardic imaging (MRI and TTE) performed during 4 months from COVID-19 infection
排除标准
- •Cardiovascular history (ischemic or valvular disease, dilated cardiomyopathy, cardiac surgery...)
- •Vulnerable patient (pregnancy, adult under legal protection)
结局指标
主要结局
To Characterize cardiac involvement by cardiac MRI during 4 months after confirmed COVID-19 infection
时间窗: 1 to 4 months after COVID 19 infection
Cardiac MRI is performed during 4 months after COVID-19 infection in patients with suspected cardiac involvement (increase troponin level\>50ng/ml or left ventricular dysfunction during hospitalisation for COVID-19 infection) in order to determine tissular characterization, in particular the presence of ischemic or non-ischemic pattern.
To Characterize cardiac involvement by cardiac TTE imaging during 4 months after confirmed COVID-19 infection
时间窗: 1 to 4 months after COVID 19 infection
Cardiac TTE imaging is performed during 4 months after COVID-19 infection in patients with suspected cardiac involvement (increase troponin level\>50ng/ml or left ventricular dysfunction during hospitalisation for COVID-19 infection) in order to determine tissular characterization, in particular the presence of ischemic or non-ischemic pattern.
次要结局
- To characterize cardiac evolution at 12 +/-2 months from COVID-19 infection(12 +/- 2 months)
- To evaluate Cardiac events at 12 +/-2 months from COVID-19 infection(12+/-2 months)
- To evaluate all cause deaths at 12 +/-2 months from COVID-19 infection(12+/-2 months)
研究者
Laura FILIPPETTI
Doctor
Central Hospital, Nancy, France
