Covid19, Viral Respiratory Infection
Conditions
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.
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.
Interventions
DIAGNOSTIC_TESTCardiac Magnetic Resonance Imaging (CMR)
Imaging
DIAGNOSTIC_TESTBlood test
Blood investigation
DIAGNOSTIC_TEST6-minute walk test
Correlating the cardiac MRI parameters with functional capacity
Sponsors
The University of Hong Kong
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The correlation of these myocardial characteristics to functional capacity (6 minute walk test) at all time-points. | 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 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Follow-up patients beyond the end of this study to assess for hard outcomes such as death. | 2 years |
Countries
Hong Kong
Outcome results
None listed