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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05184114
Other study ID # UW 21-005
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 4, 2021
Est. completion date October 31, 2024

Study information

Verified date December 2023
Source The University of Hong Kong
Contact Ming Yen Ng, BMBS
Phone 22554524
Email myng2@hku.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 myocardium. Several case studies including one from our group (recent study publication in JACC Cardiovascular Imaging led by the principal investigator of this grant application) have demonstrated subclinical myocardial inflammation in patients using cardiac magnetic resonance imaging (CMR) who have recovered from COVID-19. Furthermore at a cellular level, a recent autopsy study indicated that the severe acute respiratory syndrome coronavirus-2 is present in the myocardial tissue. The study further described invasion and viral progeny occurring in the myocardial interstitial cells and as such is a concerning development with the longer-term implications being unknown. These concerns have been noticed by the cardiology and non-cardiology medical community, with some expressing concerns of a new cause for cardiomyopathy and heart failure secondary to COVID-195. Therefore, it is critical that further studies are conducted to determine the longer-term outcome for patients.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Cardiac Magnetic Resonance, Blood Tests
Imaging, blood investigations (white cell count, C-reactive protein, NT-proBNP, lactate dehydrogenase and high sensitivity troponin)

Locations

Country Name City State
Hong Kong The University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary The extent of myocardial involvement, as assessed by CMR tissue characterisation (T1/ T2/ ECV/ LGE), 2 weeks after patient recovery, at 3-months post discharge and at 1-year post discharge. 1 year
Primary The correlation of these myocardial characteristics to biventricular structure, function (CMR cine/strain), blood biomarkers of inflammation, clinical symptoms, and functional capacity (6 minute walk test) at all time-points 2 years
Secondary Number of Participants with followed-up beyond the end of this study to assess for hard outcomes such as death. 2 years
Secondary Number of Participants with followed-up beyond the end of this study to assess for hard outcomes such as heart failure hospitalisation. 2 years
Secondary Number of Participants with cardiac arrest. 2 years
Secondary Number of Participants with ventricular tachycardia. 2 years
Secondary Number of Participants with ventricular fibrillation. 2 years
Secondary Rate of subclinical myocardial inflammation post COVID-19 vaccination. 2 years
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