Opportunistic Screening for Asymptomatic Left Ventricular Dysfunction in COVID-19 Survivors
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- New-onset cardiac arrhythmia
研究概览
简要总结
Coronavirus Disease 2019 (COVID-19) emerged in December 2019, and in mere few months has resulted in a pandemic of viral pneumonia. Substantial proportion of patients with COVID-19 have biochemical evidence of myocardial injuries during the acute phase. Possible mechanisms including acute coronary events, cytokine storm, and COVID-19 related myocarditis, have been postulated for the cardiac involvement in COVID-19. It is uncertain whether COVID-19 survivors are at risk cardiac dysfunction including cardiac arrhythmia and heart failure.
The prospective screening study aims to evaluate the possible latent effects from COVID-19 in COVID-19 survivors. COVID-19 survivors 4-6 weeks after hospital discharge will be recruited from the Infectious Disease clinic, Queen Mary Hospital with standard 12-lead electrocardiogram, serum troponin, NT-proBNP, and standard transthoracic echocardiogram.
The outcome measures include (1) new onset cardiac arrhythmia, (2) N Terminal (NT)-proBNP elevation above the diagnostic range of heart failure, and (3) newly detected left ventricular dysfunction.
详细描述
Coronavirus Disease 2019 (COVID-19) emerged in December 2019, and in mere few months has resulted in a pandemic of viral pneumonia. As of April 2020, over 2 million populations were infected and more than 150,000 deaths globally. In the initial report from Wuhan, China, up to 27.8% COVID19 patients had an elevated troponin level indicating myocardial damage during the index hospitalization for COVID. This is nearly 10-folded higher than that of other common viral illnesses such as influenza (2.9%). Possible mechanisms including acute coronary events, cytokine storm, and COVID-19 related myocarditis, have been postulated for the cardiac involvement in COVID-19. Nonetheless, it is unknown whether COVID-19 survivors are at risk cardiac dysfunction including cardiac arrhythmia and heart failure.
The prospective screening study aims to evaluate the possible latent effects from COVID-19 in COVID-19 survivors. COVID-19 survivors 4-6 weeks after hospital discharge will be recruited from the Infectious Disease clinic, Queen Mary Hospital. Standard 12-lead electrocardiogram, serum troponin, NT-proBNP, and standard transthoracic echocardiogram will be performed for COVID-19 survivors.
The outcome measures include (1) new onset cardiac arrhythmia, (2) NT-proBNP elevation above the diagnostic range of heart failure, and (3) newly detected left ventricular dysfunction.
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
- •Survivors of PCR-confirmed COVID-19
- •2-6 weeks after hospital discharge with 2 consecutive negative polymerase chain reaction (PCR) for severe acute respiratory syndrome (SARS) coronavirus (CoV)-2.
排除标准
- •Pre-existing heart failure
- •Pre-existing left ventricular systolic dysfunction (left ventricular ejection fraction < 50%)
- •Pre-existing atrial fibrillation
- •Failure to provide informed consent
结局指标
主要结局
New-onset cardiac arrhythmia
时间窗: At the time of screening
Atrial fibrillation, conduction block
Left ventricular dysfunction
时间窗: At the time of screening
Left ventricular systolic function
Elevation of NT-proBNP
时间窗: At the time of screening
Elevated NT-proBNP level above the age-specific diagnostic threshold of heart failure
次要结局
未报告次要终点