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Clinical Trials/NCT04753762
NCT04753762
Completed
Not Applicable

Multimodal IMAgery (Echocardiography and Cardiac MRI) Characterization of Cardiac Damage and Severity After COVID-19 Infection

Central Hospital, Nancy, France1 site in 1 country50 target enrollmentMarch 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19 Virus Disease
Sponsor
Central Hospital, Nancy, France
Enrollment
50
Locations
1
Primary Endpoint
To Characterize cardiac involvement by cardiac MRI during 4 months after confirmed COVID-19 infection
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Coronavirus Disease 2019 (COVID-19) is an infection caused by Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2), which affects multiple organ system particularly the lung and heart. Indeed, SARS CoV-2 has various cardiac manifestations which are associated with higher mortality and morbidity. Cardiac involvement, based on elevated levels of myocardial enzymes, have been described in 20 to 30% of COVID-19 infection. However, the physiopathological mechanisms of myocardial injury remains unclear. Main hypothesis include inflammation and cytokine storm, hypercoagulability and vascular thrombosis, inflammation or stress leading to coronary plaque rupture (type I myocardial infarction), supply-demand mismatch and hypoxemia resulting in myocardial damage (type II myocardial infarction) ...

Two patterns can be identified : ischemic or non-ischemic pattern including myocarditis, stress induced cardiomyopathy, thrombo-embolic disease. However, the consequences of myocardial damage after confirmed COVID-19 infection are unknown at medium to long term prognosis.

Data are needed to identify myocardial damage and to guide effective therapies and follow-up (use of ACE inhibitor, beta-blockers, steroids...? ) In this study, the investigators proposed to collect multimodal cardiac imaging including MRI (Magnetic Resonance Imaging) and TTE (Transthoracic echocardiogram) in order to identify and characterize cardiac injury as ischemic or non-ischemic pattern, to better assess risk stratification and to guide effective therapies if necessary.

Registry
clinicaltrials.gov
Start Date
March 1, 2020
End Date
February 1, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Principal Investigator
Principal Investigator

Laura FILIPPETTI

Doctor

Central Hospital, Nancy, France

Eligibility Criteria

Inclusion Criteria

  • Cardiac involvement confirmed : increase troponin level \> 50pg/ml or left ventricular dysfunction assessed by echocardiography during hospitalization for confirmed COVID-19 infection
  • Absence of severe renal failure (CKD EPI \> 30ml/min/1.73m²)
  • Cardic imaging (MRI and TTE) performed during 4 months from COVID-19 infection

Exclusion Criteria

  • Cardiovascular history (ischemic or valvular disease, dilated cardiomyopathy, cardiac surgery...)
  • Vulnerable patient (pregnancy, adult under legal protection)

Outcomes

Primary Outcomes

To Characterize cardiac involvement by cardiac MRI during 4 months after confirmed COVID-19 infection

Time Frame: 1 to 4 months after COVID 19 infection

Cardiac MRI is performed during 4 months after COVID-19 infection in patients with suspected cardiac involvement (increase troponin level\>50ng/ml or left ventricular dysfunction during hospitalisation for COVID-19 infection) in order to determine tissular characterization, in particular the presence of ischemic or non-ischemic pattern.

To Characterize cardiac involvement by cardiac TTE imaging during 4 months after confirmed COVID-19 infection

Time Frame: 1 to 4 months after COVID 19 infection

Cardiac TTE imaging is performed during 4 months after COVID-19 infection in patients with suspected cardiac involvement (increase troponin level\>50ng/ml or left ventricular dysfunction during hospitalisation for COVID-19 infection) in order to determine tissular characterization, in particular the presence of ischemic or non-ischemic pattern.

Secondary Outcomes

  • To characterize cardiac evolution at 12 +/-2 months from COVID-19 infection(12 +/- 2 months)
  • To evaluate Cardiac events at 12 +/-2 months from COVID-19 infection(12+/-2 months)
  • To evaluate all cause deaths at 12 +/-2 months from COVID-19 infection(12+/-2 months)

Study Sites (1)

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