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Completed

NCT Number: NCT04753762

Multimodal IMAgery Characterization of Cardiac Damage and Severity After COVID-19 Infection

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.

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Laura FILIPPETTI

Vandœuvre-lès-Nancy, 54500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. To characterize cardiac evolution at 12 +/-2 months from COVID-19 infection

    Time frame: 12 +/- 2 months

    Cardiac imaging are performed 12 +/-2 months after COVID-19 infection

  2. To evaluate Cardiac events at 12 +/-2 months from COVID-19 infection

    Time frame: 12+/-2 months

    Follow-up at 12+/-2 months from COVID-19 infection :

    • medical consultation to collect cardiac events (heart failure, arrythmias, chest pain).
  3. To evaluate all cause deaths at 12 +/-2 months from COVID-19 infection

    Time frame: 12+/-2 months

    Follow-up at 12+/-2 months from COVID-19 infection :

    • status (dead or alive)

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: IMACovid

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 15, 2021
Registry last updated
May 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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