Status:
COMPLETED
Clinical Significance of Subclinical Myocardial Involvement in Recovered COVID-19 Patients Using Cardiovascular Magnetic Resonance
Lead Sponsor:
The University of Hong Kong
Conditions:
COVID-19
Myocarditis
Eligibility:
All Genders
Phase:
NA
Brief Summary
Introduction: Coronavirus disease 2019 (COVID-19) remains a major health issue resulting in \>800,000 deaths as of 30th August 2020. A concerning discovery of COVID-19 is the involvement of the myoca...
Detailed Description
COVID-19 Cardiovascular Complications: So far, COVID-19 has been linked to myocarditis, myocardial infarction, thrombosis/ hypercoaguable state and reduced cardiac function. At an early stage of the ...
Eligibility Criteria
Inclusion
- • 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.
- Vaccination controls who planning to receive a 2-dose COVID-19 vaccine, with no history of myocardial infarction, heart failure or myocarditis AND with a confirmed negative COVID-19 RT-PCR test.
Exclusion
- 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
Key Trial Info
Start Date :
October 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2024
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT05184114
Start Date
October 4 2021
End Date
August 8 2024
Last Update
May 11 2025
Active Locations (1)
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1
The University of Hong Kong
Hong Kong, Hong Kong