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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)

Primary Purpose

Covid19, Viral Respiratory Infection

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Cardiac Magnetic Resonance Imaging (CMR)
Blood test
6-minute walk test
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Covid19

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Recovered COVID-19 patients

Recovered non-COVID-19 viral respiratory infections patients

Age and gender matched controls

Arm Description

Outcomes

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.
The correlation of these myocardial characteristics to biventricular structure at all time-points.
The correlation of these myocardial characteristics to biventricular function (CMR cine/strain) at all time-points.
The correlation of these myocardial characteristics to blood biomarkers of inflammation at all time-points.
The correlation of these myocardial characteristics to clinical symptoms at all time-points.
The correlation of these myocardial characteristics to functional capacity (6 minute walk test) at all time-points.

Secondary Outcome Measures

Follow-up patients beyond the end of this study to assess for hard outcomes such as death.
Follow-up patients beyond the end of this study to assess for hard outcomes such as heart failure hospitalisation.
Follow-up patients beyond the end of this study to assess for hard outcomes such as cardiac arrest.
Follow-up patients beyond the end of this study to assess for hard outcomes such as ventricular tachycardia/ fibrillation.

Full Information

First Posted
March 19, 2021
Last Updated
September 29, 2021
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04864899
Brief Title
Clinical Significance of Subclinical Myocardial Involvement in Recovered COVID-19 Patients Using Cardiovascular Magnetic Resonance (R-COVID-CMR)
Acronym
R-COVID-CMR
Official Title
Clinical Significance of Subclinical Myocardial Involvement in Recovered COVID-19 Patients Using Cardiovascular Magnetic Resonance (R-COVID-CMR)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
Detailed Description
This study aims to: 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. Correlate these myocardial characteristics to biventricular structure, function, blood biomarkers of inflammation, clinical symptoms, and functional capacity at all time points. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Viral Respiratory Infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recovered COVID-19 patients
Arm Type
Experimental
Arm Title
Recovered non-COVID-19 viral respiratory infections patients
Arm Type
Experimental
Arm Title
Age and gender matched controls
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Cardiac Magnetic Resonance Imaging (CMR)
Intervention Description
Imaging
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood test
Intervention Description
Blood investigation
Intervention Type
Diagnostic Test
Intervention Name(s)
6-minute walk test
Intervention Description
Correlating the cardiac MRI parameters with functional capacity
Primary Outcome Measure Information:
Title
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
Title
The correlation of these myocardial characteristics to biventricular structure at all time-points.
Time Frame
2 years
Title
The correlation of these myocardial characteristics to biventricular function (CMR cine/strain) at all time-points.
Time Frame
2 years
Title
The correlation of these myocardial characteristics to blood biomarkers of inflammation at all time-points.
Time Frame
2 years
Title
The correlation of these myocardial characteristics to clinical symptoms at all time-points.
Time Frame
2 years
Title
The correlation of these myocardial characteristics to functional capacity (6 minute walk test) at all time-points.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Follow-up patients beyond the end of this study to assess for hard outcomes such as death.
Time Frame
2 years
Title
Follow-up patients beyond the end of this study to assess for hard outcomes such as heart failure hospitalisation.
Time Frame
2 years
Title
Follow-up patients beyond the end of this study to assess for hard outcomes such as cardiac arrest.
Time Frame
2 years
Title
Follow-up patients beyond the end of this study to assess for hard outcomes such as ventricular tachycardia/ fibrillation.
Time Frame
2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-Yen NG, BMBS
Phone
22554524
Email
myng2@hku.hk
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Yen Ng, BMBS
Phone
22554524
Email
myng2@hku.hk

12. IPD Sharing Statement

Learn more about this trial

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

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