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

May 5, 2023 updated by: Laura FILIPPETTI, Central Hospital, Nancy, France

Multimodal IMAgery (Echocardiography and Cardiac MRI) 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandœuvre-lès-Nancy, France, 54500
        • Laura FILIPPETTI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 to 4 months after COVID 19 infection
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.
1 to 4 months after COVID 19 infection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 +/- 2 months
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).
12+/-2 months
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)
12+/-2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

February 11, 2021

First Posted (Actual)

February 15, 2021

Study Record Updates

Last Update Posted (Actual)

May 8, 2023

Last Update Submitted That Met QC Criteria

May 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020PI086

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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