Clinical trial NCT04753762: Multimodal IMAgery Characterization of Cardiac Damage and Severity After COVID-19 Infection
Official title: Multimodal IMAgery (Echocardiography and Cardiac MRI) Characterization of Cardiac Damage and Severity After COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Virus Disease
Cardiac Complication
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients increase troponin level \> 50ng/ml or left ventricular dysfunction assessed by echocardiography during hospitalization for confirmed COVID-19 infection

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.


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)

Primary outcomes:
measure: To Characterize cardiac involvement by cardiac TTE imaging during 4 months after confirmed COVID-19 infection
timeFrame: 1 to 4 months after COVID 19 infection
measure: To Characterize cardiac involvement by cardiac MRI during 4 months after confirmed COVID-19 infection
timeFrame: 1 to 4 months after COVID 19 infection
Secondary outcomes:
measure: To characterize cardiac evolution at 12 +/-2 months from COVID-19 infection
timeFrame: 12 +/- 2 months
measure: To evaluate Cardiac events at 12 +/-2 months from COVID-19 infection
timeFrame: 12+/-2 months
measure: To evaluate all cause deaths at 12 +/-2 months from COVID-19 infection
timeFrame: 12+/-2 months
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Laura FILIPPETTI
Study officials:
affiliation: CHRU NANCY
name: Laura FILIPPETTI, MD
role: PRINCIPAL_INVESTIGATOR
References:
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