NCT04358952

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2021

Completed
Last Updated

June 1, 2021

Status Verified

May 1, 2021

Enrollment Period

12 months

First QC Date

April 9, 2020

Last Update Submit

May 28, 2021

Conditions

Keywords

Left ventricular systolic functionleft ventricular diastolic functionglobal longitudinal strainSARS-Cov-2Covid-19

Outcome Measures

Primary Outcomes (3)

  • Left ventricular function

    Left ventricular function evaluated by global longitudinal strain

    Day 0

  • Left ventricular function

    Left ventricular function evaluated by global longitudinal strain

    Day 3

  • Left ventricular function

    Left ventricular function evaluated by global longitudinal strain

    Day 7

Secondary Outcomes (1)

  • inflammatory biological parameters

    Day 0

Study Arms (1)

COVID + patients

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

Diagnostic Test: Global Longitudinal Strain

Interventions

Electrocardiogram with measure of the Global Longitudinal Strain to evaluate myocardiac dysfunction

COVID + patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHToulouse

Toulouse, 31059, France

Location

Related Publications (1)

  • Lairez O, Blanchard V, Balardy L, Vardon-Bounes F, Cazalbou S, Ruiz S, Collot S, Houard V, Rolland Y, Conil JM, Minville V. COCARDE Study-Cardiac Imaging Phenotype in Patients With COVID-19: Protocol for a Prospective Observational Study. JMIR Res Protoc. 2022 Jan 6;11(1):e24931. doi: 10.2196/24931.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Inflammatory cytokines

MeSH Terms

Conditions

CardiomyopathiesCOVID-19

Interventions

Global Longitudinal Strain

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

HemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Vincent MINVILLE, PU-PH

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 24, 2020

Study Start

April 4, 2020

Primary Completion

April 2, 2021

Study Completion

April 2, 2021

Last Updated

June 1, 2021

Record last verified: 2021-05

Locations