Myocarditis AcuteMICROMYOCNCT07676201
One-year Prognostic Impact of Microcirculation Assessed by NH IMR Angio in Patients Hospitalized for Acute Myocarditis
An observational study of Myocarditis Acute, run by University Hospital, Grenoble.
Trial summary
The goal of this observational study is to evaluate the association between post-coronary angiography IMR and medium-term clinical prognosis in patients with acute myocarditis. The main question it aims to answer is: Is there a correlation between impaired microcirculation and the occurrence of serious clinical events… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocarditis Acute
- What is being tested?
- Coronary catheterization
- Type of treatment
- Surgery or procedure
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2026to 15 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 hospitalized in the cardiology department at CHUGA between 2015 and 2025 who had a diagnosis of myocarditis confirmed by cardiac MRI.
Who may be able to join
- Male or female patients over the age of 18.
- Patients hospitalized between June 2015 and July 2025.
- Patients who presented with chest pain and at least 1 diagnostic criterion; or, in the absence of chest pain, at least 2 of the following diagnostic criteria:
- Electrocardiographic abnormalities (ST-segment elevation or depression, T-wave inversions, conduction disturbances such as type 3 atrioventricular block),
- Elevated troponin levels,
- Abnormal kinematics on echocardiography.
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- Associated with MRI findings of ≥2 tissue abnormalities (edema, hyperemia, myocardial fibrosis).
- Coronary angiography performed during the initial hospitalization
- Patient enrolled in or eligible for a social security program.
- Patient who has expressed consent to participate.
Who cannot join
- Absence of coronary artery disease confirmed by coronary angiography
- Myocarditis secondary to immunotherapy
- Presence of documented coronary artery disease (coronary angiography or cardiac CT)
- Presence of cardiomyopathy (hypertrophic cardiomyopathy, dilated cardiomyopathy)
- Infiltrative heart disease (sarcoidosis or cardiac amyloidosis)
- Severe valvular heart disease
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- Takotsubo syndrome
- Constrictive or chronic pericarditis
- Loeffler's endocarditis
- Left ventricular noncompaction
- Cardiac tumor
- Pulmonary embolism
- Coronary spasm
- Patients covered by Articles L1121-5 through L1121-8 of the Public Health Code (pregnant women, women in labor, and breastfeeding women; persons deprived of their liberty by judicial or administrative decision; adults under guardianship)
About this study
The goal of this observational study is to evaluate the association between post-coronary angiography IMR and medium-term clinical prognosis in patients with acute myocarditis. The main question it aims to answer is:
Is there a correlation between impaired microcirculation and the occurrence of serious clinical events in this population of patients?
- Conditions
- Myocarditis Acute
- Being tested
- Coronary catheterization
- Keywords
- NH IMR, Coronary catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary catheterizationProcedure or surgery
Coronary catheterization
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
The primary endpoint is the 1-year incidence rate of MACE. MACE is defined by a composite endpoint comprising: 1) all-cause mortality, 2) cardiac decompensation requiring readmission, 3) heart transplantation, 4) documented sustained ventricular arrhythmia lasting >30 seconds, and 5) recurrence of myocarditis.
Measured: From the time of the coronary angiography up to one year
Secondary outcomes (4)
Individual components of the 12-month MACE: cardiovascular death, transplantation, hospitalization for heart failure, and persistent heart failure (reported separately)
Measured: From the time of the coronary angiography up to one year
Correlation between IMR angiographic NH (continuous variable) and: a) MRI imaging criteria (LVEF, fibrosis, septal involvement, edema); b) biological markers (maximum troponin, CRP)
Measured: From the time of the coronary angiography up to one year
Predictive value of MRI angiography: diagnostic performance in predicting the primary endpoint (ROC, optimal cut-off values, sensitivity/specificity)
Measured: From the time of the coronary angiography up to one year
Assessment of inter- and intra-observer reproducibility of the MR angiography NH calculation (if a subsample is reanalyzed)
Measured: From the time of the coronary angiography up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start15 Jul 2026 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocarditis AcuteStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Retrospective
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676201
- Sponsor's protocol ID
- 38RC26.0180
- Acronym
- MICROMYOC
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 30 Jun 2026
- 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 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-year Prognostic Impact of Microcirculation Assessed by NH IMR Angio in Patients Hospitalized for Acute Myocarditis
- ClinicalTrials.gov ID
- NCT07676201
- Acronym / sponsor ID
- MICROMYOC / 38RC26.0180
- Conditions
- Myocarditis Acute
- Keywords
- NH IMR, Coronary catheterization
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 30 Jun 2026 (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 goal of this observational study is to evaluate the association between post-coronary angiography IMR and medium-term clinical prognosis in patients with acute myocarditis. The main question it aims to answer is:
Is there a correlation between impaired microcirculation and the occurrence of serious clinical events in this population of patients?
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients hospitalized in the cardiology department at CHUGA between 2015 and 2025 who had a diagnosis of myocarditis confirmed by cardiac MRI.
Key inclusion criteria (10 listed)
- Male or female patients over the age of 18.
- Patients hospitalized between June 2015 and July 2025.
- Patients who presented with chest pain and at least 1 diagnostic criterion; or, in the absence of chest pain, at least 2 of the following diagnostic criteria:
- Associated with MRI findings of ≥2 tissue abnormalities (edema, hyperemia, myocardial fibrosis).
- Coronary angiography performed during the initial hospitalization
Key exclusion criteria (14 listed)
- Absence of coronary artery disease confirmed by coronary angiography
- Myocarditis secondary to immunotherapy
- Presence of documented coronary artery disease (coronary angiography or cardiac CT)
- Presence of cardiomyopathy (hypertrophic cardiomyopathy, dilated cardiomyopathy)
- Infiltrative heart disease (sarcoidosis or cardiac amyloidosis)
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 |
|---|---|---|
| Coronary catheterizationCoronary catheterization | Procedure or surgery | – |
Primary outcome
MACE
Time frame: From the time of the coronary angiography up to one year
The primary endpoint is the 1-year incidence rate of MACE. MACE is defined by a composite endpoint comprising: 1) all-cause mortality, 2) cardiac decompensation requiring readmission, 3) heart transplantation, 4) documented sustained ventricular arrhythmia lasting >30 seconds, and 5) recurrence of myocarditis.
4 secondary outcomes
Individual components of the 12-month MACE: cardiovascular death, transplantation, hospitalization for heart failure, and persistent heart failure (reported separately)
Time frame: From the time of the coronary angiography up to one year
Correlation between IMR angiographic NH (continuous variable) and: a) MRI imaging criteria (LVEF, fibrosis, septal involvement, edema); b) biological markers (maximum troponin, CRP)
Time frame: From the time of the coronary angiography up to one year
Predictive value of MRI angiography: diagnostic performance in predicting the primary endpoint (ROC, optimal cut-off values, sensitivity/specificity)
Time frame: From the time of the coronary angiography up to one year
Assessment of inter- and intra-observer reproducibility of the MR angiography NH calculation (if a subsample is reanalyzed)
Time frame: From the time of the coronary angiography up to one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocarditis Acute, run by University Hospital, Grenoble.
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 10 inclusion and 14 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: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
MACE (time frame: From the time of the coronary angiography up to one year). 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 Jun 2026.