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

NCT04355884 | Unknown

• 1 other identifier: COVID_LVD_SCREEN
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

Standard 12-lead ECG, NT-proBNP, echocardiography DIAGNOSTIC_TEST

Cardiac assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Survivors of PCR-confirmed COVID-19 2-6 weeks after hospital discharge with 2 consecutive negative PCR for SARS-CoV-2 and without pre-existing heart failure, left ventricular dysfunction, and/or atrial fibrillation

You may qualify if:

• Survivors of PCR-confirmed COVID-19
• weeks after hospital discharge with 2 consecutive negative polymerase chain reaction (PCR) for severe acute respiratory syndrome (SARS) coronavirus (CoV)-2.

You may not qualify if:

• Pre-existing heart failure
• Pre-existing left ventricular systolic dysfunction (left ventricular ejection fraction \< 50%)
• Pre-existing atrial fibrillation
• Failure to provide informed consent

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong, Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

COVID-19

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Central Study Contacts

Chung Wah SIU, MD

CONTACT

852-2255-4694; cwdsiu@hku.hk

Venus HO, BSc

CONTACT

*52-22553597; vslho@hku.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: April 21, 2020
• Study Start: April 20, 2020
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

HK (1)