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

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

Detailed Description
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This study aims to: 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. Correlate these myocardial characteristics to biventricular structure, function, blood biomarkers of inflammation, clinical symptoms, and functional capacity at all time points. 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.

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

Conditions
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Covid19, Viral Respiratory Infection

Intervention / Treatment
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* Diagnostic Test: Cardiac Magnetic Resonance Imaging (CMR)
* Diagnostic Test: Blood test
* Diagnostic Test: 6-minute walk test


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |