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Enrolling by Invitation

NCT Number: NCT07325968

Cardiac MRI 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.

Enrolling by Invitation

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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.

Treatment and study plan

Primary outcomes

  1. Major adverse cardiac events

    Time frame: 1-10 years

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

Secondary outcomes

  1. A composite of SCD and aborted SCD

    Time frame: 1-10 years

    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

  2. Progress to dilated cardiomyopathy (DCM)

    Time frame: 1-10 years

    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.

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study title

Cardiac MRI Phenotypes and Prognostic Stratification in Myocarditis and Inflammatory Cardiomyopathy

Acronym: CMR-MYOINF-PRO

Important dates

Study start
2008
Primary completion
2030
Study completion
2032
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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