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

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ClinicalTrials.gov Identifier: NCT04753762
Recruitment Status : Recruiting
First Posted : February 15, 2021
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
Laura FILIPPETTI, Central Hospital, Nancy, France

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.


Condition or disease
COVID-19 Virus Disease Cardiac Complication

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Multimodal IMAgery (Echocardiography and Cardiac MRI) Characterization of Cardiac Damage and Severity After COVID-19 Infection
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : November 1, 2022



Primary Outcome Measures :
  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 Outcome Measures :
  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)




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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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)

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): NCT04753762


Contacts
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Contact: Laura FILIPPETTI, MD +33383153240 l.filippetti@chru-nancy.fr
Contact: Aboubaker CHERIFI, Ms a.cherifi@chru-nancy.fr

Locations
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France
Laura FILIPPETTI Recruiting
Vandœuvre-lès-Nancy, France, 54500
Contact: Laura FILIPPETTI, MD    +33383153240    l.filippetti@chru-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Laura FILIPPETTI, MD CHRU NANCY
Publications of Results:

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Responsible Party: Laura FILIPPETTI, Doctor, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04753762    
Other Study ID Numbers: 2020PI086
First Posted: February 15, 2021    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 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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Virus Diseases