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

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ClinicalTrials.gov Identifier: NCT04864899
Recruitment Status : Recruiting
First Posted : April 29, 2021
Last Update Posted : September 30, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Ng Ming-Yen, The University of Hong Kong

Study Description
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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
Covid19 Viral Respiratory Infection Diagnostic Test: Cardiac Magnetic Resonance Imaging (CMR) Diagnostic Test: Blood test Diagnostic Test: 6-minute walk test Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Significance of Subclinical Myocardial Involvement in Recovered COVID-19 Patients Using Cardiovascular Magnetic Resonance (R-COVID-CMR)
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : March 30, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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. [ Time Frame: 2 years ]
  2. The correlation of these myocardial characteristics to biventricular structure at all time-points. [ Time Frame: 2 years ]
  3. The correlation of these myocardial characteristics to biventricular function (CMR cine/strain) at all time-points. [ Time Frame: 2 years ]
  4. The correlation of these myocardial characteristics to blood biomarkers of inflammation at all time-points. [ Time Frame: 2 years ]
  5. The correlation of these myocardial characteristics to clinical symptoms at all time-points. [ Time Frame: 2 years ]
  6. The correlation of these myocardial characteristics to functional capacity (6 minute walk test) at all time-points. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Follow-up patients beyond the end of this study to assess for hard outcomes such as death. [ Time Frame: 2 years ]
  2. Follow-up patients beyond the end of this study to assess for hard outcomes such as heart failure hospitalisation. [ Time Frame: 2 years ]
  3. Follow-up patients beyond the end of this study to assess for hard outcomes such as cardiac arrest. [ Time Frame: 2 years ]
  4. Follow-up patients beyond the end of this study to assess for hard outcomes such as ventricular tachycardia/ fibrillation. [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04864899


Contacts
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Contact: Ming-Yen NG, BMBS 22554524 myng2@hku.hk

Locations
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Hong Kong
The University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Ming Yen Ng, BMBS    22554524    myng2@hku.hk   
Sponsors and Collaborators
The University of Hong Kong
More Information
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Responsible Party: Dr. Ng Ming-Yen, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04864899    
Other Study ID Numbers: UW21-005
First Posted: April 29, 2021    Key Record Dates
Last Update Posted: September 30, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases