Opportunistic Screening for Asymptomatic Left Ventricular Dysfunction in Coronavirus Disease 2019 (COVID19) Survivors

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Opportunistic Screening for Asymptomatic Left Ventricular Dysfunction in COVID-19 Survivors

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Diagnostic Test: Standard 12-lead ECG, NT-proBNP, echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: Pre-existing heart failure Pre-existing left ventricular systolic dysfunction (left ventricular ejection fraction < 50%) Pre-existing atrial fibrillation Failure to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Standard 12-lead ECG, NT-proBNP, echocardiography|Cardiac assessment|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New-onset cardiac arrhythmia | Atrial fibrillation, conduction block | At the time of screening | 
| Elevation of NT-proBNP | Elevated NT-proBNP level above the age-specific diagnostic threshold of heart failure | At the time of screening | 
| Left ventricular dysfunction | Left ventricular systolic function | At the time of screening |