Prevalence of Silent Myocardial Scars on Cardiac Magnetic Resonance Following COVID-19 Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 231
- 试验地点
- 2
- 主要终点
- Prevalence of myocardial scars
研究概览
简要总结
The aim of this study is to assess the prevalence and arrhythmogenic role of occult myocardial scars on Cardiac Magnetic Resonance (CMR) in a population of patients with history of laboratory-proven symptomatic COVID-19 infection managed without hospitalization, as compared to a population of age- and sex-matched healthy volunteers.
详细描述
Multiple large series conducted in hospitalized patients have reported high rates of myocardial injuries in the acute stage of COVID-19 infection. These findings have raised concerns regarding potential long term consequences of the pandemic on cardiovascular diseases (heart failure and sudden cardiac deaths due to scar-related arrhythmias). However, the prevalence of silent myocardial injuries in the general population who presented a COVID-19 infection managed without hospitalization are unknown. In addition, the propensity of these scars to generate arrhythmias have not been thoroughly studied. COVID CMR will include 120 patients with history of laboratory-proven symptomatic COVID-19 infection managed without hospitalization and 120 age- and sex-matched controls. At day 1, all subjects will undergo a 12-lead electrocardiogram, a contrast-enhanced CMR study including advanced methods to detect silent myocardial scars, and a blood sample to look for markers of inflammation and cardiac injury, and to assess the COVID-19 serological status at the time of the CMR study. The prevalence of myocardial scars on CMR will be compared between the 2 groups. In a second visit at 3 months, patients showing myocardial scar on CMR will be matched to healthy volunteers showing no such scars, and these 2 population subsets will undergo exercise electrocardiogram (ECG) and 24 hour Holter ECG to characterize the arrhythmogenic role of silent myocardial scars.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Man or woman ≥ 18 years old
- •Affiliated to a health insurance program
- •Providing free, informed, written and signed consent to participate (at the latest on the day of inclusion and before any research procedure is initiated)
- •Effective contraception if women in the age to procreate
- •In the patient group : history of COVID-19 infection with either a positive Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) test on nasopharyngeal swab or a positive COVID-19 serology in the acute stage. Presence of all following symptoms in the acute stage: fever>38°C, asthenia, arthromyalgia, associated with at least 2 of the following: coughing and/or spitting, dyspnea and/or chest discomfort, anosmia and/or ageusia.
排除标准
- •age < 18 years old
- •History of cardiac disease or acute coronary syndrome associated with troponin rise
- •History of allergic reaction to gadolinium-based contrast agents
- •History of severe renal failure
- •Presence of a pacemaker, implantable defibrillator, intra-orbital metallic material, intra-cranial surgical clip, valve prosthesis Star-Edwards pre 6000, neurostimulator or implantable insulin pump
- •Claustrophobia or inability to lay on the back for 50 min
- •Pregnant or breast feeding women
- •Inability to express informed consent
- •Person deprived of liberty by judicial or administrative decision
- •Person under legal protection
- •In the healthy volunteer group:
- •Symptoms suggestive of COVID-19 infection over the epidemic period (after February 1st 2020)
- •Person not willing to be informed of potential incidental CMR findings
- •In the patient group:
- •Hospitalization for infectious syndrome suggestive of COVID-19.
结局指标
主要结局
Prevalence of myocardial scars
时间窗: Day 0
Expressed in percentage of participant, as assessed on late gadolinium-enhanced magnetic resonance acquired at high resolution using a free breathing 3D method.
次要结局
- CMR feature : native T1 and T2 values(Day 0)
- CMR feature : extracellular volume fraction(Day 0)
- CMR feature : ventricular volumes(Day 0)
- CMR feature : myocardial strain(Day 0)
- CMR feature : Location and size of myocardial scars(Day 0)
- ECG features(Baseline and month 3)
- Biological feature : troponin level(Day 0)
- CMR feature : ejection fraction(Day 0)
- Biological feature : inflammatory markers level(Day 0)
- Genetic profile research(Day 0)
- Biological feature : positivity of COVID-19 serology(Baseline and month 3)