Clinical Significance of Subclinical Myocardial Involvement in Recovered COVID-19 Patients Using Cardiovascular Magnetic Resonance (R-COVID-CMR)
Study Details
Study Description
Brief Summary
This is a prospective cohort study that aims to clinical significance of subclinical myocardial involvement in recovered COVID-19 patients using cardiovascular magnetic resonance.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This study aims to:
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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.
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Correlate these myocardial characteristics to biventricular structure, function, blood biomarkers of inflammation, clinical symptoms, and functional capacity at all time points.
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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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
• Recovered COVID-19 patients
Definition of recovered COVID-19 patient:
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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.
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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.
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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.
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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:
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Previous myocardial infarction or myocarditis unrelated to COVID-19 infection
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History of heart failure unrelated to COVID-19 infection
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Presence of pacemakers or implantable cardiac defibrillators
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Any contraindication for CMR testing
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Renal impairment with eGFR <45ml/min/1.73m2
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Limited life expectancy <1 year, for example due to pulmonary disease, cancer or significant hepatic failure
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Refusal or inability to sign an informed consent.
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Potential for non-compliance towards the requirements in the trial protocol (especially the medical treatment) or follow-up visits
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Hong Kong | Hong Kong | Hong Kong |
Sponsors and Collaborators
- The University of Hong Kong
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UW21-005