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Enrolling by invitationNCT07325968CMR-MYOINF-PROUpdated Jan 8, 2026

Cardiac MRI in Myocarditis and Inflammatory Cardiomyopathy

An observational study in Myocarditis and Inflammatory Cardiomyopathy, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Enrolling by invitation. Per ClinicalTrials.gov, last updated 2026-01-08.

Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
5,000
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Myocarditis
  • Inflammatory Cardiomyopathy

Keywords

  • Cardiac MRI (CMR)
  • Diagnosis
  • Prognosis
  • Risk stratificaiton
  • Radiogenomics
03

In context

Myocarditis

174 studies on the registry are indexed under Myocarditis; 75 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 208 across 120 observational studies indexed under Myocarditis.

Browse Myocarditis studies →

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 147 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This study examined patients with myocarditis or inflammatory cardiomyopathy who underwent cardiac MRI scanning.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 , elevated high-sensitivity cardiac troponin I level, and functional and structural abnormalities at US imaging.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
5,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • Myocarditis

    Patients with myocarditis

  • Inflammatory cardiomyopathy

    Patients with inflammatory cardiomyopathy

06

What researchers measure

Primary outcomes

  1. Major adverse cardiac events

    Cardiac death, heart transplantation, recurrence of myocarditis, sustained ventricular tachycardia and hospitalization for heart failure

    Time frame: 1-10 years

Secondary outcomes

  1. 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

    Time frame: 1-10 years

  2. 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.

    Time frame: 1-10 years

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Study locations

No study locations are listed for this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2008 (actual). Primary completion is estimated for Dec 2030, 275 months after the start.

Of 70 non-industry observational studies under Myocarditis, half reached primary completion within 69 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 251. This study's planned 275 months is above that.

Counting every sponsor, half of 71 studies reached it within 69 months; a quarter within 20 and three quarters within 251.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 25, 2025
First posted
Jan 8, 2026
StartActual
Jan 1, 2008
Primary completionEst.
Dec 31, 2030
CompletionEst.
Dec 31, 2032
Last update
Jan 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07325968
Responsible party
Minjie Lu (MD, PhD, Chinese Academy of Medical Sciences, Fuwai Hospital) — Principal investigator
First posted
Jan 8, 2026
Start date
Jan 1, 2008
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2032 (estimated)
Last update
Jan 8, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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