Myocardial Involvement of Severe Acute Respiratory Syndrome-Cov-2 (Covid19) Infected Patients (COCARDE)

May 28, 2021 updated by: University Hospital, Toulouse

Imaging Cardiac Phenotype of SARS-Cov-2 (Covid19) Infected Patients

The effects of severe acute respiratory syndrome SARS-Cov-2 (Covid-19) on the myocardium and their role in the clinical course of infected patients are still unknown. Epidemiological studies report biological myocardial involvement in 10 to 25% of cases. The objective of this study is to cardiac phenotype using comprehensive cardiac imaging tools of patients infected with Covid 19 in order to explore the functional impact of the infection on the myocardium.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A large population of Covid 19 infected patients of different ages and severity levels will be explored by transthoracic echocardiography with measurement of myocardial functional parameters such as ejection fraction, longitudinal strain and relaxation parameters and will be compared to an uninfected population paired for age and sex.

Patients with biological myocardial involvement will be followed to determine the evolution of their myocardial functional parameters during the course of the infection.

Study Type

Observational

Enrollment (Actual)

122

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
      • Toulouse, France, 31059
        • UHToulouse

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Major patients hospitalized for respiratory criteria for SARS-Cov-2 infection confirmed by RT-PCR

Description

Inclusion Criteria:

  • Major patients hospitalized for respiratory criteria for SARS-Cov-2 infection confirmed by RT-PCR

Exclusion Criteria:

  • Underage patients. Patients refusing to participate in research. Patients with a history of heart disease.

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID + patients
Major patients hospitalized for respiratory criteria for SARS-Cov-2 infection confirmed by RT-PCR
Diagnostic test: Global Longitudinal Strain
Electrocardiogram with measure of the Global Longitudinal Strain to evaluate myocardiac dysfunction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular function
Time Frame: Day 0
Left ventricular function evaluated by global longitudinal strain
Day 0
Left ventricular function
Time Frame: Day 3
Left ventricular function evaluated by global longitudinal strain
Day 3
Left ventricular function
Time Frame: Day 7
Left ventricular function evaluated by global longitudinal strain
Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
inflammatory biological parameters
Time Frame: Day 0
Cytokine rate
Day 0

Collaborators and Investigators

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

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Vincent MINVILLE, PU-PH, University Hospital, Toulouse

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)

April 4, 2020

Primary Completion (Actual)

April 2, 2021

Study Completion (Actual)

April 2, 2021

Study Registration Dates

First Submitted

April 9, 2020

First Submitted That Met QC Criteria

April 20, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

June 1, 2021

Last Update Submitted That Met QC Criteria

May 28, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/20/0117
  • 2020-A00852-37 (Other Identifier: ID RCB)

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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