Clinical Significance of Subclinical Myocardial Involvement in Recovered COVID-19 Patients Using Cardiovascular Magnetic Resonance (R-COVID-CMR) (R-COVID-CMR)

This is a prospective cohort study that aims to clinical significance of subclinical myocardial involvement in recovered COVID-19 patients using cardiovascular magnetic resonance.

Study Overview

• Status: Recruiting
• Conditions: Covid19; Viral Respiratory Infection
• Intervention / Treatment: Diagnostic test: Cardiac Magnetic Resonance Imaging (CMR); Diagnostic test: Blood test; Diagnostic test: 6-minute walk test

Detailed Description

This study aims to:

1. Determine the extent of myocardial involvement of COVID-19, as assessed by Cardiovascular Magnetic Resonance (CMR), 2 weeks after patient recovery, at 3-month post discharge and at 1-year post discharge.
2. Correlate these myocardial characteristics to biventricular structure, function, blood biomarkers of inflammation, clinical symptoms, and functional capacity at all time points.
3. Follow up recovered COVID-19 patients beyond the end of this study to assess for hard outcomes such as death, heart failure hospitalization, cardiac arrest and ventricular tachycardia/ fibrillation.

Recovered COVID-19 patients and age and gender matched controls subjects will be recruited.

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ming-Yen NG, BMBS; Phone Number: 22554524; Email: myng2@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The University of Hong Kong
    • Contact: Ming Yen Ng, BMBS; Phone Number: 22554524; Email: myng2@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Recovered COVID-19 patients

Definition of recovered COVID-19 patient:

• COVID-19 diagnosis = established by a positive reverse transcription polymerase chain reaction (RT-PCR) for severe acute respiratory syndrome coronavirus-2 [SARS-CoV2] and recovered from COVID-19.

• Recovery = based on two criteria: (1) two negative nasopharyngeal swab RT-PCR results >24 hours apart and (2) absence of fever and improvement in respiratory symptoms.

  • Recovered non-COVID-19 patients with viral respiratory infections confirmed with viral polymerase chain reaction testing AND with a confirmed negative COVID-19 RT-PCR test.
  • Age and gender matched controls with no cardiac risk factors, not on cardiac medications, no history of myocardial infarction, heart failure or myocarditis, negative COVID-19 RT-PCR test and negative COVID-19 antibodies test.

Exclusion Criteria:

• Previous myocardial infarction or myocarditis unrelated to COVID-19 infection
• History of heart failure unrelated to COVID-19 infection
• Presence of pacemakers or implantable cardiac defibrillators
• Any contraindication for CMR testing
• Renal impairment with eGFR <45ml/min/1.73m2
• Limited life expectancy <1 year, for example due to pulmonary disease, cancer or significant hepatic failure
• Refusal or inability to sign an informed consent.
• Potential for non-compliance towards the requirements in the trial protocol (especially the medical treatment) or follow-up visits

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Recovered COVID-19 patients	Diagnostic test: Cardiac Magnetic Resonance Imaging (CMR); Imaging; Diagnostic test: Blood test; Blood investigation; Diagnostic test: 6-minute walk test; Correlating the cardiac MRI parameters with functional capacity
Experimental: Recovered non-COVID-19 viral respiratory infections patients	Diagnostic test: Cardiac Magnetic Resonance Imaging (CMR); Imaging; Diagnostic test: Blood test; Blood investigation; Diagnostic test: 6-minute walk test; Correlating the cardiac MRI parameters with functional capacity
Experimental: Age and gender matched controls	Diagnostic test: Cardiac Magnetic Resonance Imaging (CMR); Imaging; Diagnostic test: Blood test; Blood investigation; Diagnostic test: 6-minute walk test; Correlating the cardiac MRI parameters with functional capacity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The extent of myocardial involvement, as assessed by CMR tissue characterisation (T1/ T2/ ECV/ LGE), change from 2 weeks after patient recovery, at 3-months post discharge and at 1-year post discharge.	2 years
The correlation of these myocardial characteristics to biventricular structure at all time-points.	2 years
The correlation of these myocardial characteristics to biventricular function (CMR cine/strain) at all time-points.	2 years
The correlation of these myocardial characteristics to blood biomarkers of inflammation at all time-points.	2 years
The correlation of these myocardial characteristics to clinical symptoms at all time-points.	2 years
The correlation of these myocardial characteristics to functional capacity (6 minute walk test) at all time-points.	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Follow-up patients beyond the end of this study to assess for hard outcomes such as death.	2 years
Follow-up patients beyond the end of this study to assess for hard outcomes such as heart failure hospitalisation.	2 years
Follow-up patients beyond the end of this study to assess for hard outcomes such as cardiac arrest.	2 years
Follow-up patients beyond the end of this study to assess for hard outcomes such as ventricular tachycardia/ fibrillation.	2 years

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: April 27, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Actual): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiratory Tract Infections
• Other Study ID Numbers: UW21-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No