Acute MyocarditisMYOCOVIDNCT04375748
Hospital Registry of Acute Myocarditis: Evolution of the Proportion of Positive SARS-COV-2 (COVID19) Cases
An observational study of Acute Myocarditis, run by University Hospital, Toulouse at 65 sites in 4 countries.
Trial summary
To date, the effects of SARS-Cov-2 (Covid-19) on the myocardium and the role it plays in the evolution towards an acute myocarditis are badly understood. The current pandemic of this emerging virus is an opportunity to assess the proportion of acute myocarditis attributable to SARS-Cov-2(Covid-19) and to assess the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myocarditis
- What is being tested?
- Performing routine care (clinical and paraclinical tests) and Examinations for the research:
- How many people
- 756 participants
- Where
- 65 sitesin 4 countries
- Study dates
- 15 Apr 2020to 28 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated in ICCU or ICU (polyvalent, surgical or medical), in one of the participating hospitals
Who may be able to join
- Patients treated in ICCU or ICU (polyvalent, surgical or medical), in one of the participating hospitals, for symptoms of acute myocarditis confirmed by a myocardial MRI and/or a CT scan and/or a myocardial biopsy. It seems important to include elderly patients who may be under guardianship or curatorship since these patients seem to present the most severe forms. Additionally, the populations most affected by viral myocarditis are generally adolescents and young adults,which justifies including them in the study too. Pregnant women are a population at potentially greater risk, particularly during the third trimester because of the neuro-hormonal changes inherent in pregnancy. This justifies trying to implement the investigator's knowledge through this observational study.
Who cannot join
- Refusal to participate.
Trial locations and contacts
65 sites in 4 countries.
65 sites in 4 countries
France62 sites
Cardiology
Aix-en-Provence
Reanimation
Amiens
Cardiology
Angers
Reanimation
Angers
Cardiology
Avignon
Cardiology
Bordeaux
Pediatric cardiology
Bordeaux
Reanimation
Bordeaux
Cardiology
Brest
Cardiology
Caen
Pediatric Cardiology
Caen
Cardiology
Clermont-Ferrand
Pediatric cardilogy
Clermont-Ferrand
Reanimation
Clermont-Ferrand
Pediatric cardiology
Dijon
Cardiology
Grenoble
Pediatric cardiology
Grenoble
Reanimation
Grenoble
Cardiology
Lille
Pediatric cardiology
Lille
Pediatric cardiology
Limoges
Cardiology
Lyon
Pediatric cardiology
Lyon
Cardiology
Marseille
Pediatric cardiology
Marseille
Cardiology
Metz
Cardiology
Montpellier
Millénaire Clinical - Cardiology
Montpellier
Pediatric cardiology
Montpellier
Reanimation
Montpellier
Cardiology
Nancy
Pediatric cardiology
Nancy
Cardiology
Nantes
Pediatric cardiology
Nantes
Cardiology
Nice
Pediatric cardiology
Nice
Cardiology
Nîmes
Cardiology, Henri Mondor Hospital
Paris
Cardiology
Paris
Henri Mondor Hospital Reanimation
Paris
Marie Lannelongue Hospital - Pediatric Cardiology
Paris
Marie Lannelongue Hospital Cardiology
Paris
Reanimation
Paris
Robert Debré Hospital - Pediatric cardiology
Paris
Saint Antoine Hospital - Cardiology
Paris
Cardiology
Poitiers
Reanimation
Poitiers
Pediatric cardiology
Reims
Cardiology
Rennes
Pediatric reanimation
Rennes
Cardiology
Rouen
Pediatric cardiology
Rouen
Pédiatric cardiology
Strasbourg
Reanimation
Strasbourg
CHU de TOULOUSE
Toulouse, 31000
Croix du Sud Clinical
Toulouse
Pasteur Clinical - Cardiology
Toulouse
Pasteur Clinical - Pediatric cardiology
Toulouse
Pediatric Cardiology
Toulouse
Cardiolgy
Tours
Pediatric Cardiology
Tours
Cardiology
Valenciennes
Mayotte1 site
Cardiology
Mamoudzou
About this study
Official title: Hospital Registry of Acute Myocarditis: Evolution of the Proportion of Positive SARS-COV-2 Cases During the Covid-19 Pandemic, Case Characteristics and Prognoses
To date, the effects of SARS-Cov-2 (Covid-19) on the myocardium and the role it plays in the evolution towards an acute myocarditis are badly understood. The current pandemic of this emerging virus is an opportunity to assess the proportion of acute myocarditis attributable to SARS-Cov-2(Covid-19) and to assess the clinical, biological and imaging presentations, by means of a national prospective multicentre hospital registry of cases of acute myocarditis.
Read the detailed description
Although research on the subject has only recently started developing, the links have already been described between SARS-Cov-2 infection, the severity of the clinical status, and the presence of risk factors or a history of cardiovascular disease (hypertension, diabetes, stroke, etc.). Additionally, depending on the series and definition used for cardiac injury (troponin elevation and/or natriuretic peptides), this concerns 7-29% of patients with a clear predominance in severe patients. The mechanisms behind these troponin elevations and cardiac injury are likely to be multiple and variable depending on clinical presentation,severity and patient history. A significant association was found between troponin elevation, and that of CRP and NtproBNP, suggesting an inflammatory part to this cardiac damage. As with other coronaviruses, SARS-Cov-2 infection can cause massive release of proinflammatory cytokines which can lead to inflammation of the vascular wall. This can be the cause of true instability or even rupture of plaque(type1 infarction) but can also be responsible for tissue hypoxia without rupture of plaque causing myocardial pain (infarction type 2). In addition, there may be areal myocardial inflammation causing acute myocarditis, secondary to the cytokine storm or direct damage to the myocardium by the virus itself. In case of acute coronary syndrome presentation, a coronary exploration should be realized to highlight or eliminate a type 1 infarction, but it is clearly difficult to distinguish between a type 2 suffering (no viral attack direct but suffering from hypotension or hypoxia for example) and inflammatory myocardial damage with or without direct viral myocardial damage (myocarditis). In the context of the viral pandemic at Covid19, although few data exist,it is legitimate to consider the possibility of true arrays of acute inflammatory myocarditis or by direct viral attack which could thus modify the natural history and the prognosis of patients, thus justifying a dedicated diagnosis and treatment. The primary objective was to assess the proportion of positive SARS-Cov-2 cases among the patients included (hospitalized for acute myocarditis). During the study period, this proportion will be assessed at regular intervals, for example every month, or more frequently if the number of patients included varies substantially from one week to another. This will make it possible to trace a development curve for the entire period of the pandemic.
The secondary objectives were (1) to describe the clinical, biological and imaging characteristics of the acute myocarditis among the positive and negative SARS-Cov-2 patients of the myocarditis cohort; (2) to assess the short-term (30 days) and long-term (1 year) prognosis of the acute myocarditis among the positive and negative SARS-Cov-2 patients of the myocarditis cohort and (3) to identify the factors associated with a 30-day and 1-year prognosis of cases of acute myocarditis.
- Conditions
- Acute Myocarditis
- Being tested
- Performing routine care (clinical and paraclinical tests), Examinations for the research:
- Keywords
- Covid19, Myocarditis, Epidemiology, Prognosis, Mortality
- Medical subject headings
- COVID-19, Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performing routine care (clinical and paraclinical tests)Diagnostic test
ECG, standard biology and cardiology tests, and routine transthoracic echocardiography (TTE), MRI
Examinations for the research:Diagnostic test
Systematic research by polymerase chain reaction (PCR) for Covid-19 in the blood and in an oro-pharyngeal swab, in addition to the usual immunologic, bacteriological, viral and parasitic tests carried out as part of the routine care of all patients with suspected myocarditis.
A 30-days phone call follow-up (vital status) and a systematic 1-year follow-up will be realized (clinic, biology, ECG, TTE, +/- MRI)
| Study group | Role | What they receive |
|---|---|---|
| Patients treated for symptoms of acute myocarditis. | Patients treated in intensive coronary care unit (ICCU) or intensive care unit (ICU), in one of the participating hospitals, for symptoms of acute myocarditis confirmed by a myocardial MRI and/or a CT scan and/or a myocardial biopsy. Receives: Diagnostic Test: Performing routine care (clinical and paraclinical tests); Diagnostic Test: Examinations for the research: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the proportion of positive SARS-COV-2 cases.
Estimate at hospital discharge, over a period of 6 months, the evolution of the proportion of positive SARS-COV-2 cases among patients hospitalized for acute myocarditis in Intensive Cardiac Care Unit or Intensive Care Unit (polyvalent, surgical or medical), in the 19 hospitals participating in the study.
Measured: 6 months.
Secondary outcomes (26)
Ultrasound characteristics.
Describe at the admission and during the treatment ultrasound characteristics of the acute myocarditis among the positive and negative SARS-Cov-2 patients of the myocarditis cohort; Echocardiographic parameters: Volumes (mm3)
Measured: 1 year
Ultrasound characteristics.
Describe at the admission and during the treatment ultrasound characteristics of the acute myocarditis among the positive and negative SARS-Cov-2 patients of the myocarditis cohort ; Echocardiographic parameters: diameters (mm)
Measured: 1 year
Ultrasound characteristics.
Describe at the admission and during the treatment ultrasound characteristics of the acute myocarditis among the positive and negative SARS-Cov-2 patients of the myocarditis cohort (Echocardiographic parameters: ventricular diastolic function (mm);
Measured: 1 year
Ultrasound characteristics.
Describe at the admission and during the treatment ultrasound characteristics of the acute myocarditis among the positive and negative SARS-Cov-2 patients of the myocarditis cohort (Echocardiographic parameters: ventricular systolic function (mm);
Measured: 1 year
Ultrasound characteristics.
Describe at the admission and during the treatment ultrasound characteristics of the acute myocarditis among the positive and negative SARS-Cov-2 patients of the myocarditis cohort ; Echocardiographic parameters: Left atrium volume (mm3);
Measured: 1 year
Ultrasound characteristics.
Describe at the admission and during the treatment ultrasound characteristics of the acute myocarditis among the positive and negative SARS-Cov-2 patients of the myocarditis cohort ; Echocardiographic parameters: Maximum velocity of tricuspid valve insufficiency;
Measured: 1 year
Ultrasound characteristics.
Describe at the admission and during the treatment ultrasound characteristics of the acute myocarditis among the positive and negative SARS-Cov-2 patients of the myocarditis cohort ; Echocardiographic parameters: Presence and quantification of a valvular regurgitation
Measured: 1 year
Ultrasound characteristics.
Describe at the admission and during the treatment ultrasound characteristics of the acute myocarditis among the positive and negative SARS-Cov-2 patients of the myocarditis cohort ; Echocardiographic parameters: Presence of a pericardial effusion
Measured: 1 year
Assess prognosis of the acute myocarditis .
Assess the short-term (30 days) and long-term (1 year) prognosis of the acute myocarditis among the positive and negative SARS-Cov-2 patients of the myocarditis cohort. The 30-day prognosis will be defined in function to the outcome: A death, whatever the cause, A cardiovascular arrest with recovery, A cardiogenic shock, An acute lung oedema or One of the events cited above.
The 1-year prognosis will be defined in function to the outcome: A death, whatever the cause, The need to resort to transplantation and/or chronic assistance, A rehospitalization for cardiovascular reasons (heart failure, painful relapse, recovered cardiac arrest, myocarditis relapse, ACS), A myocarditis relapse, or one of the events cited above. The 1-year prognosis will also be defined in function to the New York Heart Association
(NYHA) class.
Measured: The short-term (30 days) and long-term (1 year).
The factors associated with acute myocarditis cases .
Identify the factors associated with a 30-day and 1-year prognosis of cases of acute myocarditis cardiovascular (Terminal heart failure, Acute edema of the lung, Cardiogenic shock, Sudden death / Ventricular rhythm disorder Pulmonary embolism, Aortic dissection Infectious endocarditis Stroke) or no cardiovascular (Acute respiratory syndrome, septic shock of non-cardiac origin, cancer, Public road accident, end-stage respiratory failure, insufficiency, end-stage renal Failure)
Measured: The short-term (30 days) and long-term (1 year).
Biological characteristics
Describe the biological parameters on admission and during the treatment (troponinemia (ng/ml)
Measured: 1 year
Biological characteristics
Describe the biological parameters on admission and during the treatment NtproBNP(pg/ml)
Measured: 1 year
Biological characteristics
Describe the biological parameters on admission and during the treatment CRP(mg/ml)
Measured: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Ventricular volumes (ml)
Measured: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Systole Diameter
Measured: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Diastole Diameter
Measured: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Longitudinal deformation of left ventricle;
Measured: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Longitudinal deformation of right ventricle;
Measured: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Total volume of left ventricular oedema
Measured: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Quantification of T2 before contrast agent
Measured: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Quantification of T1 before contrast agent
Measured: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Perfusion anomalies
Measured: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Total volume of early left ventricular alteration
Measured: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Total volume of late left ventricular alteration
Measured: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Quantification of T1 after contrast agent
Measured: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Presence of a pericardial effusion
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start15 Apr 2020
- Primary completion28 Dec 2021
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute MyocarditisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 756 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clément Delmas, Principal investigator, CHU Toulouse, Hôpital Rangueil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375748
- Sponsor's protocol ID
- RC31/20/0139
- Acronym
- MYOCOVID
- Status last verified
- Jul 2023
- First submitted
- 21 Apr 2020
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital Registry of Acute Myocarditis: Evolution of the Proportion of Positive SARS-COV-2 Cases During the Covid-19 Pandemic, Case Characteristics and Prognoses
- ClinicalTrials.gov ID
- NCT04375748
- Acronym / sponsor ID
- MYOCOVID / RC31/20/0139
- Conditions
- Acute Myocarditis
- Keywords
- Covid19, Myocarditis, Epidemiology, Prognosis, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 756 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 28 Dec 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 5 May 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.
To date, the effects of SARS-Cov-2 (Covid-19) on the myocardium and the role it plays in the evolution towards an acute myocarditis are badly understood. The current pandemic of this emerging virus is an opportunity to assess the proportion of acute myocarditis attributable to SARS-Cov-2(Covid-19) and to assess the clinical, biological and imaging presentations, by means of a national prospective multicentre hospital registry of cases of acute myocarditis.
Detailed description
Although research on the subject has only recently started developing, the links have already been described between SARS-Cov-2 infection, the severity of the clinical status, and the presence of risk factors or a history of cardiovascular disease (hypertension, diabetes, stroke, etc.). Additionally, depending on the series and definition used for cardiac injury (troponin elevation and/or natriuretic peptides), this concerns 7-29% of patients with a clear predominance in severe patients. The mechanisms behind these troponin elevations and cardiac injury are likely to be multiple and variable depending on clinical presentation,severity and patient history. A significant association was found between troponin elevation, and that of CRP and NtproBNP, suggesting an inflammatory part to this cardiac damage. As with other coronaviruses, SARS-Cov-2 infection can cause massive release of proinflammatory cytokines which can lead to inflammation of the vascular wall. This can be the cause of true instability or even rupture of plaque(type1 infarction) but can also be responsible for tissue hypoxia without rupture of plaque causing myocardial pain (infarction type 2). In addition, there may be areal myocardial inflammation causing acute myocarditis, secondary to the cytokine storm or direct damage to the myocardium by the virus itself. In case of acute coronary syndrome presentation, a coronary exploration should be realized to highlight or eliminate a type 1 infarction, but it is clearly difficult to distinguish between a type 2 suffering (no viral attack direct but suffering from hypotension or hypoxia for example) and inflammatory myocardial damage with or without direct viral myocardial damage (myocarditis). In the context of the viral pandemic at Covid19, although few data exist,it is legitimate to consider the possibility of true arrays of acute inflammatory myocarditis or by direct viral attack which could thus modify the natural history and the prognosis of patients, thus justifying a dedicated diagnosis and treatment. The primary objective was to assess the proportion of positive SARS-Cov-2 cases among the patients included (hospitalized for acute myocarditis). During the study period, this proportion will be assessed at regular intervals, for example every month, or more frequently if the number of patients included varies substantially from one week to another. This will make it possible to trace a development curve for the entire period of the pandemic.
The secondary objectives were (1) to describe the clinical, biological and imaging characteristics of the acute myocarditis among the positive and negative SARS-Cov-2 patients of the myocarditis cohort; (2) to assess the short-term (30 days) and long-term (1 year) prognosis of the acute myocarditis among the positive and negative SARS-Cov-2 patients of the myocarditis cohort and (3) to identify the factors associated with a 30-day and 1-year prognosis of cases of acute myocarditis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated for symptoms of acute myocarditis. | – | Diagnostic Test: Performing routine care (clinical and paraclinical tests), Diagnostic Test: Examinations for the research:Patients treated in intensive coronary care unit (ICCU) or intensive care unit (ICU), in one of the participating hospitals, for symptoms of acute myocarditis confirmed by a myocardial MRI and/or a CT scan and/or a myocardial biopsy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated in ICCU or ICU (polyvalent, surgical or medical), in one of the participating hospitals
Key inclusion criteria (1 listed)
- Patients treated in ICCU or ICU (polyvalent, surgical or medical), in one of the participating hospitals, for symptoms of acute myocarditis confirmed by a myocardial MRI and/or a CT scan and/or a myocardial biopsy. It seems important to include elderly patients who may be under guardianship or curatorship since these patients seem to present the most severe forms. Additionally, the populations most affected by viral myocarditis are generally adolescents and young adults,which justifies including them in the study too. Pregnant women are a population at potentially greater risk, particularly during the third trimester because of the neuro-hormonal changes inherent in pregnancy. This justifies trying to implement the investigator's knowledge through this observational study.
Key exclusion criteria (1 listed)
- Refusal to participate.
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 |
|---|---|---|
| Performing routine care (clinical and paraclinical tests)ECG, standard biology and cardiology tests, and routine transthoracic echocardiography (TTE), MRI | Diagnostic test | Patients treated for symptoms of acute myocarditis. |
| Examinations for the research:Systematic research by polymerase chain reaction (PCR) for Covid-19 in the blood and in an oro-pharyngeal swab, in addition to the usual immunologic, bacteriological, viral and parasitic tests carried out as part of the routine care of all patients with suspected myocarditis. A 30-days phone call follow-up (vital status) and a systematic 1-year follow-up will be realized (clinic, biology, ECG, TTE, +/- MRI) | Diagnostic test | Patients treated for symptoms of acute myocarditis. |
Primary outcome
Evolution of the proportion of positive SARS-COV-2 cases.
Time frame: 6 months.
Estimate at hospital discharge, over a period of 6 months, the evolution of the proportion of positive SARS-COV-2 cases among patients hospitalized for acute myocarditis in Intensive Cardiac Care Unit or Intensive Care Unit (polyvalent, surgical or medical), in the 19 hospitals participating in the study.
26 secondary outcomes
Ultrasound characteristics.
Time frame: 1 year
Ultrasound characteristics.
Time frame: 1 year
Ultrasound characteristics.
Time frame: 1 year
Ultrasound characteristics.
Time frame: 1 year
Ultrasound characteristics.
Time frame: 1 year
Ultrasound characteristics.
Time frame: 1 year
Ultrasound characteristics.
Time frame: 1 year
Ultrasound characteristics.
Time frame: 1 year
Assess prognosis of the acute myocarditis .
Time frame: The short-term (30 days) and long-term (1 year).
The factors associated with acute myocarditis cases .
Time frame: The short-term (30 days) and long-term (1 year).
Biological characteristics
Time frame: 1 year
Biological characteristics
Time frame: 1 year
Biological characteristics
Time frame: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Time frame: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Time frame: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Time frame: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Time frame: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Time frame: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Time frame: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Time frame: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Time frame: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Time frame: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Time frame: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Time frame: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Time frame: 1 year
Describe at the admission and during the treatment cardiac MRI parameters
Time frame: 1 year
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 24 Jul 2023.
Related trials for Acute Myocarditis
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
RecruitingObservational study
MYocarditis and/or Pericarditis Following mRNA COVID-19 VACCination National Surveillance Study
Myocarditis, Myocarditis Acute
Recruiting
Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support
Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall
Not yet recruitingPhase 1
64Cu-GRIP B in Patients With Acute Myocarditis
Acute Myocarditis
Enrolling by invitationObservational study
Multimodal Physiologic State Intelligence Study
Heart Failure, Cardiomyopathies
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.
Clément Delmas principal investigator
CHU Toulouse, Hôpital Rangueil
65 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocarditis, run by University Hospital, Toulouse at 65 sites in 4 countries.
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 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in France, Martinique, Mayotte, Reunion. 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?
Evolution of the proportion of positive SARS-COV-2 cases. (time frame: 6 months.). 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 24 Jul 2023.