MyocarditisNCT05911386
Multiparametric Echocardiography and Cardiac Biomarkers in Pediatric Inflammatory Heart Diseases
An observational study of Myocarditis and Pediatric Inflammatory Multisystem Syndrome, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Acquired inflammatory or infectious cardiac diseases, in pediatrics, include Kawasaki disease, myocarditis, and Covid-19-related Pediatric Multisystemic Inflammatory Syndrome (PIMS). These 3 inflammatory cardiac diseases have clinical, biological, and echographic similarities and differences. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Myocarditis, Pediatric Inflammatory Multisystem Syndrome, Kawasaki Disease
- What is being tested?
- study of biological samples and echocardiographic data and link with need of hemodynamic support
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2023to Sep 2023
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: age < 18 years initial management and follow up in Nancy university children hospital center for PIMS Myocarditis and Kawasaki disease patients
Who may be able to join
- diagnostic of PIMS, myocarditis or kawasaki disease patients
- age < 18 years
Who cannot join
- uncertain diagnosis
- other complex heart disease
- management out of Nancy University children hospital center
Trial locations and contacts
1 site in 1 country.
France1 site
Gilles BOSSER
Vandœuvre-lès-Nancy, 54511
Gilles BOSSER, PhD, g.bosser@chru-nancy.fr
About this study
Official title: Multiparametric Echocardiography and Cardiac Biomarkers in Pediatric Inflammatory Heart Diseases (Including Pediatric Inflammatory Multisystemic Syndromes Related to Covid 19, Kawasaki Disease and Myocarditis)
Acquired inflammatory or infectious cardiac diseases, in pediatrics, include Kawasaki disease, myocarditis, and Covid-19-related Pediatric Multisystemic Inflammatory Syndrome (PIMS).
These 3 inflammatory cardiac diseases have clinical, biological, and echographic similarities and differences. Nevertheless their modalities of monitoring, management and evolution are different. The investigators wish to retrospectively analyze biological and echocardiographic data of Kawasaki disease, myocarditis, PIMS patients managed at Nancy Children Hospital from January 1, 2017 to June 31, 2023.
Read more
The primary objective of this study is to identify, for these 3 pathologies, the prognostic factors of initiation of inotropic support.
The secondary objective is to identify the prognostic factors of degradation of ventricular function.
- Being tested
- study of biological samples and echocardiographic data and link with need of hemodynamic support
- Medical subject headings
- Myocarditis, pediatric multisystem inflammatory disease, COVID-19 related, Mucocutaneous Lymph Node Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
study of biological samples and echocardiographic data and link with need of hemodynamic supportOther
observational study : there is no intervention
| Study group | Role | What they receive |
|---|---|---|
| MYOCARDITIS | No intervention Study of available clinical, biological, and echocardiographic data Receives: Other: study of biological samples and echocardiographic data and link with need of hemodynamic support | |
| KAWASAKI | No intervention Study of available clinical, biological, and echocardiographic data Receives: Other: study of biological samples and echocardiographic data and link with need of hemodynamic support | |
| PIMS | No intervention Study of available clinical, biological, and echocardiographic data Receives: Other: study of biological samples and echocardiographic data and link with need of hemodynamic support |
What is being measured
The primary outcome is the main question the study is designed to answer.
need of hemodynamic support
The need for haemodynamic support is defined dichotomously: yes or no. The investigators wish to identify the predictive factors of need for haemodynamic support among the following variables: groups (PIMS, KAWASAKI, MYOCARDITIS), cardiac biomarkers (troponin and NT-pro-BNP at admission (in ng/ml)) and echocardiographic criterias (Left Ventricular Ejection fraction, global and regional longitudinal strain at admission (in %)).
Measured: up to 20 days
Secondary outcomes (1)
deterioration of Left Ventricular Ejection fraction
Left Ventricular Ejection fraction degradation is defined as an Left Ventricular Ejection fraction below the value of the first quartile of Left Ventricular Ejection fraction of all patients taken into account (Left Ventricular Ejection fraction as a percentage).
The investigators wish to identify the predictive factors of Left Ventricular Ejection fraction degradation among the following variables: groups (PIMS, KAWASAKI, MYOCARDITIS), cardiac biomarkers (troponin and NT-pro-BNP at admission (in ng/ml)) and echocardiographic criterias (Left Ventricular Ejection fraction , global and regional longitudinal strain at admission (in %)).
Measured: up to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study startSep 2023 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyocarditisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BOSSER Gilles, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911386
- Sponsor's protocol ID
- 2023PI058
- Status last verified
- Aug 2023
- First submitted
- 9 May 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric Echocardiography and Cardiac Biomarkers in Pediatric Inflammatory Heart Diseases (Including Pediatric Inflammatory Multisystemic Syndromes Related to Covid 19, Kawasaki Disease and Myocarditis)
- ClinicalTrials.gov ID
- NCT05911386
- Acronym / sponsor ID
- 2023PI058
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 22 Jun 2023 (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.
Acquired inflammatory or infectious cardiac diseases, in pediatrics, include Kawasaki disease, myocarditis, and Covid-19-related Pediatric Multisystemic Inflammatory Syndrome (PIMS).
These 3 inflammatory cardiac diseases have clinical, biological, and echographic similarities and differences. Nevertheless their modalities of monitoring, management and evolution are different. The investigators wish to retrospectively analyze biological and echocardiographic data of Kawasaki disease, myocarditis, PIMS patients managed at Nancy Children Hospital from January 1, 2017 to June 31, 2023.
The primary objective of this study is to identify, for these 3 pathologies, the prognostic factors of initiation of inotropic support.
The secondary objective is to identify the prognostic factors of degradation of ventricular function.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MYOCARDITIS | – | Other: study of biological samples and echocardiographic data and link with need of hemodynamic supportNo intervention Study of available clinical, biological, and echocardiographic data |
| KAWASAKI | – | Other: study of biological samples and echocardiographic data and link with need of hemodynamic supportNo intervention Study of available clinical, biological, and echocardiographic data |
| PIMS | – | Other: study of biological samples and echocardiographic data and link with need of hemodynamic supportNo intervention Study of available clinical, biological, and echocardiographic data |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- age < 18 years initial management and follow up in Nancy university children hospital center for PIMS Myocarditis and Kawasaki disease patients
Key inclusion criteria (2 listed)
- diagnostic of PIMS, myocarditis or kawasaki disease patients
- age < 18 years
Key exclusion criteria (3 listed)
- uncertain diagnosis
- other complex heart disease
- management out of Nancy University children hospital center
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 |
|---|---|---|
| study of biological samples and echocardiographic data and link with need of hemodynamic supportobservational study : there is no intervention | Other | KAWASAKI, MYOCARDITIS, PIMS |
Primary outcome
need of hemodynamic support
Time frame: up to 20 days
The need for haemodynamic support is defined dichotomously: yes or no. The investigators wish to identify the predictive factors of need for haemodynamic support among the following variables: groups (PIMS, KAWASAKI, MYOCARDITIS), cardiac biomarkers (troponin and NT-pro-BNP at admission (in ng/ml)) and echocardiographic criterias (Left Ventricular Ejection fraction, global and regional longitudinal strain at admission (in %)).
1 secondary outcome
deterioration of Left Ventricular Ejection fraction
Time frame: up to 20 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: No
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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.
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 Myocarditis and Pediatric Inflammatory Multisystem Syndrome, run by Central Hospital, Nancy, France 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aurelien Capogna (+33603566308, a.capogna@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
need of hemodynamic support (time frame: up to 20 days). 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 30 Aug 2023.