CardiomyopathiesCOCARDENCT04358952
Myocardial Involvement of Severe Acute Respiratory Syndrome-Cov-2 (Covid19) Infected Patients
An observational study of Cardiomyopathies, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathies
- What is being tested?
- Global Longitudinal Strain
- How many people
- 122 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2020to 2 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Major patients hospitalized for respiratory criteria for SARS-Cov-2 infection confirmed by RT-PCR
Who may be able to join
- Major patients hospitalized for respiratory criteria for SARS-Cov-2 infection confirmed by RT-PCR
Who cannot join
- Underage patients. Patients refusing to participate in research. Patients with a history of heart disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiomyopathies
- Being tested
- Global Longitudinal Strain
- Keywords
- Left ventricular systolic function, left ventricular diastolic function, global longitudinal strain, SARS-Cov-2, Covid-19
- Medical subject headings
- Cardiomyopathies, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global Longitudinal StrainDiagnostic test
Electrocardiogram with measure of the Global Longitudinal Strain to evaluate myocardiac dysfunction
| Study group | Role | What they receive |
|---|---|---|
| COVID + patients | Major patients hospitalized for respiratory criteria for SARS-Cov-2 infection confirmed by RT-PCR Receives: Diagnostic Test: Global Longitudinal Strain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular function
Left ventricular function evaluated by global longitudinal strain
Measured: Day 0
Left ventricular function
Left ventricular function evaluated by global longitudinal strain
Measured: Day 3
Left ventricular function
Left ventricular function evaluated by global longitudinal strain
Measured: Day 7
Secondary outcomes (1)
inflammatory biological parameters
Cytokine rate
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start4 Apr 2020
- Primary completion2 Apr 2021
- Study completion2 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CardiomyopathiesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent MINVILLE, PU-PH, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358952
- Sponsor's protocol ID
- RC31/20/0117
- Other IDs
- 2020-A00852-37
- Acronym
- COCARDE
- Status last verified
- May 2021
- First submitted
- 9 Apr 2020
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34751159
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Cardiac Phenotype of SARS-Cov-2 (Covid19) Infected Patients
- ClinicalTrials.gov ID
- NCT04358952
- Acronym / sponsor ID
- COCARDE / RC31/20/0117
- Conditions
- Cardiomyopathies
- Keywords
- Left ventricular systolic function, left ventricular diastolic function, global longitudinal strain, SARS-Cov-2, Covid-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 4 Apr 2020 (actual)
- Primary completion
- 2 Apr 2021 (actual)
- Study completion
- 2 Apr 2021 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID + patients | – | Diagnostic Test: Global Longitudinal StrainMajor patients hospitalized for respiratory criteria for SARS-Cov-2 infection confirmed by RT-PCR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major patients hospitalized for respiratory criteria for SARS-Cov-2 infection confirmed by RT-PCR
Key inclusion criteria (1 listed)
- Major patients hospitalized for respiratory criteria for SARS-Cov-2 infection confirmed by RT-PCR
Key exclusion criteria (1 listed)
- Underage patients. Patients refusing to participate in research. Patients with a history of heart disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Global Longitudinal StrainElectrocardiogram with measure of the Global Longitudinal Strain to evaluate myocardiac dysfunction | Diagnostic test | COVID + patients |
Primary outcome
Left ventricular function
Time frame: Day 0
Left ventricular function evaluated by global longitudinal strain
Left ventricular function
Time frame: Day 3
Left ventricular function evaluated by global longitudinal strain
Left ventricular function
Time frame: Day 7
Left ventricular function evaluated by global longitudinal strain
1 secondary outcome
inflammatory biological parameters
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Derived from this study: PubMed 34751159Lairez 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.
Related trials for Cardiomyopathies
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent MINVILLE, PU-PH principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathies, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular function (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04358952, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.