Covid19DOMY COVIDNCT04498065
MYocardial DOmmages Related to COVID-19
An observational study of Covid19 and Non Ischemic Myocardial Injury, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Myocardial injury, as assessed by elevation of cardiac troponins (Tnc), is frequent among patients with COVID-19. Although rare autopsy cases reported COVID-19 related myocardial inflammation, the origin of Tnc elevation is unknown to date. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Non Ischemic Myocardial Injury, Myocardial Infarction
- What is being tested?
- Biological data and Clinical data
- How many people
- 273 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 31 May 2022
- 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: Patients admitted to CHU Dijon Bourgogne for COVID-19
Who may be able to join
- COVID-19 positive patient hospitalized < 72 h after symptoms onset with troponin assessement.
Who cannot join
- patients hospitalized > 72h after symptom onset
Trial locations and contacts
1 site in 1 country.
About this study
Myocardial injury, as assessed by elevation of cardiac troponins (Tnc), is frequent among patients with COVID-19. Although rare autopsy cases reported COVID-19 related myocardial inflammation, the origin of Tnc elevation is unknown to date. Several cardiac causes, such as myocarditis, non-ischemic myocardial injury (NIMI), or myocardial infarction (MI) may lead to Tnc kinetic. Our work will test the hypothesis that during SARS-Cov2 infection, the elevation of cardiac biomarkers could be linked to the occurrence of myocarditis.
- Conditions
- Covid19, Non Ischemic Myocardial Injury, Myocardial Infarction, Myocarditis, Troponin Elevation
- Being tested
- Biological data, Clinical data
- Medical subject headings
- COVID-19, Myocardial Infarction, Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological dataBiological
Biological data
Clinical dataOther
Clinical data
| Study group | Role | What they receive |
|---|---|---|
| A | COVID positive and Troponin positive Receives: Biological: Biological data; Other: Clinical data | |
| B | COVID positive and Troponin negative Receives: Biological: Biological data; Other: Clinical data |
What is being measured
The primary outcome is the main question the study is designed to answer.
characterize the myocardial damage associated with CoV-2 SARS infection
Myocardtitis diagnosis in patients COVID+ and troponin+
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start1 Mar 2020
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498065
- Sponsor's protocol ID
- COTTIN AOIc 2020
- Acronym
- DOMY COVID
- Status last verified
- Sep 2022
- First submitted
- 3 Aug 2020
- Last updated
- 22 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MYocardial DOmmages Related to COVID-19
- ClinicalTrials.gov ID
- NCT04498065
- Acronym / sponsor ID
- DOMY COVID / COTTIN AOIc 2020
- Conditions
- Covid19, Non Ischemic Myocardial Injury, Myocardial Infarction, Myocarditis, Troponin Elevation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 4 Aug 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.
Myocardial injury, as assessed by elevation of cardiac troponins (Tnc), is frequent among patients with COVID-19. Although rare autopsy cases reported COVID-19 related myocardial inflammation, the origin of Tnc elevation is unknown to date. Several cardiac causes, such as myocarditis, non-ischemic myocardial injury (NIMI), or myocardial infarction (MI) may lead to Tnc kinetic. Our work will test the hypothesis that during SARS-Cov2 infection, the elevation of cardiac biomarkers could be linked to the occurrence of myocarditis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Biological: Biological data, Other: Clinical dataCOVID positive and Troponin positive |
| B | – | Biological: Biological data, Other: Clinical dataCOVID positive and Troponin negative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to CHU Dijon Bourgogne for COVID-19
Key inclusion criteria (1 listed)
- COVID-19 positive patient hospitalized < 72 h after symptoms onset with troponin assessement.
Key exclusion criteria (1 listed)
- patients hospitalized > 72h after symptom onset
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 |
|---|---|---|
| Biological dataBiological data | Biological | A, B |
| Clinical dataClinical data | Other | A, B |
Primary outcome
characterize the myocardial damage associated with CoV-2 SARS infection
Time frame: Through study completion, an average of 2 years
Myocardtitis diagnosis in patients COVID+ and troponin+
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 22 Sep 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Covid19 and Non Ischemic Myocardial Injury, run by Centre Hospitalier Universitaire Dijon 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 22 Sep 2022. 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?
characterize the myocardial damage associated with CoV-2 SARS infection (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2022.