MyocarditisCMR-MYOINF-PRONCT07325968
Cardiac MRI in Myocarditis and Inflammatory Cardiomyopathy
An observational study of Myocarditis and Inflammatory Cardiomyopathy, run by Chinese Academy of Medical Sciences, Fuwai Hospital.
Trial summary
Myocarditis and inflammatory cardiomyopathy represent a broad spectrum of myocardial inflammatory disorders with highly variable clinical presentations and outcomes, ranging from spontaneous recovery to progressive heart failure, malignant arrhythmias, and sudden cardiac death. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocarditis, Inflammatory Cardiomyopathy
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 31 Dec 2032
- How long will I take part?
- 5 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study examined patients with myocarditis or inflammatory cardiomyopathy who underwent cardiac MRI scanning.
Who may be able to join
- Patients with clinically suspected acute myocarditis: clinical presentations of myocarditis, including acute chest pain, chest tightness, new-onset or worsening dyspnea, unexplained arrhythmia symptoms, and/or syncope or unexplained cardiogenic shock; diagnostic factors, including abnormal 12-lead electrocardiogram, elevated high-sensitivity cardiac troponin I level, and functional and structural abnormalities at US imaging.
Who cannot join
- Patients were excluded if they had any evidence of coronary artery disease (coronary stenosis > 50% proven by angiography) and/ or other pre-existing cardiac disease or systemic disease with interpretable symptoms, including hypertrophic cardiomyopathy, cardiac amyloidosis, arrhythmogenic right ventricular cardiomyopathy, takotsubo cardiomyopathy, ventricular noncompaction, valve disease, and pulmonary embolism.
About this study
Official title: Cardiac MRI Phenotypes and Prognostic Stratification in Myocarditis and Inflammatory Cardiomyopathy
Myocarditis and inflammatory cardiomyopathy represent a broad spectrum of myocardial inflammatory disorders with highly variable clinical presentations and outcomes, ranging from spontaneous recovery to progressive heart failure, malignant arrhythmias, and sudden cardiac death. Despite advances in clinical management, risk assessment in this population remains challenging due to heterogeneous disease mechanisms, dynamic disease courses, and limited tools for individualized prognostic stratification. Biopsy-proven myocarditis has been reported to be associated with a long-term mortality rate of up to 19.2% over 4.7 years.
Cardiac Magnetic Resonance Imaging (CMR) has become a central imaging modality for the evaluation of myocardial inflammation, offering comprehensive assessment of cardiac structure, function, and tissue characteristics. Beyond conventional parameters such as ventricular volumes and ejection fraction, advanced CMR techniques, including late gadolinium enhancement and parametric mapping, enable noninvasive characterization of myocardial injury, edema, and fibrosis. Emerging quantitative and distribution-based imaging markers further expand the potential of CMR to capture myocardial heterogeneity.
However, the clinical implications of diverse CMR phenotypes in myocarditis and inflammatory cardiomyopathy, particularly their value for outcome prediction and risk stratification, remain incompletely defined. This study aims to systematically evaluate CMR-derived phenotypes and their association with clinical outcomes, and to explore the role of CMR in improving risk stratification strategies in patients with myocarditis and inflammatory cardiomyopathy. Where available, genetic data will be integrated to explore potential relationships between CMR phenotypes and underlying genetic variations, further informing disease characterization and risk assessment.
- Conditions
- Myocarditis, Inflammatory Cardiomyopathy
- Keywords
- Cardiac MRI (CMR), Diagnosis, Prognosis, Risk stratificaiton, Radiogenomics
- Medical subject headings
- Myocarditis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Myocarditis | Patients with myocarditis | |
| Inflammatory cardiomyopathy | Patients with inflammatory cardiomyopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
Cardiac death, heart transplantation, recurrence of myocarditis, sustained ventricular tachycardia and hospitalization for heart failure
Measured: 1-10 years
Secondary outcomes (2)
A composite of SCD and aborted SCD
SCD, defined as unexpected death within ≤1 hour of cardiac symptoms in the absence of any progressive cardiac deterioration, during sleep, or ≤24 hours of last being seen alive. Aborted SCD, defined as an appropriate implantable cardioverter defibrillator shock for ventricular arrhythmia, a nonfatal episode of ventricular fibrillation or spontaneous sustained ventricular tachycardia causing hemodynamic compromise and requiring cardioversion
Measured: 1-10 years
Progress to dilated cardiomyopathy (DCM)
Progression to dilated cardiomyopathy will be defined by the development of left ventricular dilation accompanied by systolic dysfunction during follow-up, as assessed by cardiac imaging and clinical evaluation.
Measured: 1-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Jan 2008
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2032 (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 Chinese Academy of Medical Sciences, Fuwai HospitalThe 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
- Other
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minjie Lu, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325968
- Sponsor's protocol ID
- CMR-MYOINF-PROG
- Acronym
- CMR-MYOINF-PRO
- Status last verified
- Dec 2025
- First submitted
- 25 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac MRI Phenotypes and Prognostic Stratification in Myocarditis and Inflammatory Cardiomyopathy
- ClinicalTrials.gov ID
- NCT07325968
- Acronym / sponsor ID
- CMR-MYOINF-PRO / CMR-MYOINF-PROG
- Conditions
- Myocarditis, Inflammatory Cardiomyopathy
- Keywords
- Cardiac MRI (CMR), Diagnosis, Prognosis, Risk stratificaiton, Radiogenomics
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 8 Jan 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.
Myocarditis and inflammatory cardiomyopathy represent a broad spectrum of myocardial inflammatory disorders with highly variable clinical presentations and outcomes, ranging from spontaneous recovery to progressive heart failure, malignant arrhythmias, and sudden cardiac death. Despite advances in clinical management, risk assessment in this population remains challenging due to heterogeneous disease mechanisms, dynamic disease courses, and limited tools for individualized prognostic stratification. Biopsy-proven myocarditis has been reported to be associated with a long-term mortality rate of up to 19.2% over 4.7 years.
Cardiac Magnetic Resonance Imaging (CMR) has become a central imaging modality for the evaluation of myocardial inflammation, offering comprehensive assessment of cardiac structure, function, and tissue characteristics. Beyond conventional parameters such as ventricular volumes and ejection fraction, advanced CMR techniques, including late gadolinium enhancement and parametric mapping, enable noninvasive characterization of myocardial injury, edema, and fibrosis. Emerging quantitative and distribution-based imaging markers further expand the potential of CMR to capture myocardial heterogeneity.
However, the clinical implications of diverse CMR phenotypes in myocarditis and inflammatory cardiomyopathy, particularly their value for outcome prediction and risk stratification, remain incompletely defined. This study aims to systematically evaluate CMR-derived phenotypes and their association with clinical outcomes, and to explore the role of CMR in improving risk stratification strategies in patients with myocarditis and inflammatory cardiomyopathy. Where available, genetic data will be integrated to explore potential relationships between CMR phenotypes and underlying genetic variations, further informing disease characterization and risk assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myocarditis | – | –Patients with myocarditis |
| Inflammatory cardiomyopathy | – | –Patients with inflammatory cardiomyopathy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study examined patients with myocarditis or inflammatory cardiomyopathy who underwent cardiac MRI scanning.
Key inclusion criteria (1 listed)
- Patients with clinically suspected acute myocarditis: clinical presentations of myocarditis, including acute chest pain, chest tightness, new-onset or worsening dyspnea, unexplained arrhythmia symptoms, and/or syncope or unexplained cardiogenic shock; diagnostic factors, including abnormal 12-lead electrocardiogram, elevated high-sensitivity cardiac troponin I level, and functional and structural abnormalities at US imaging.
Key exclusion criteria (1 listed)
- Patients were excluded if they had any evidence of coronary artery disease (coronary stenosis > 50% proven by angiography) and/ or other pre-existing cardiac disease or systemic disease with interpretable symptoms, including hypertrophic cardiomyopathy, cardiac amyloidosis, arrhythmogenic right ventricular cardiomyopathy, takotsubo cardiomyopathy, ventricular noncompaction, valve disease, and pulmonary embolism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major adverse cardiac events
Time frame: 1-10 years
Cardiac death, heart transplantation, recurrence of myocarditis, sustained ventricular tachycardia and hospitalization for heart failure
2 secondary outcomes
A composite of SCD and aborted SCD
Time frame: 1-10 years
Progress to dilated cardiomyopathy (DCM)
Time frame: 1-10 years
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 8 Jan 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 and Inflammatory Cardiomyopathy, run by Chinese Academy of Medical Sciences, Fuwai Hospital.
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: enrolling by invitation, as of the sponsor's last update on 8 Jan 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?
Major adverse cardiac events (time frame: 1-10 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 8 Jan 2026.