The Application of T1 Mapping in Real-World

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Enrolling

Conditions: Arrhythmogenic Cardiomyopathy; Myocarditis; Dilated Cardiomyopathy (DCM); Myocardial Infarction (MI); Hypertrophic Cardiomyopathy (HCM)

Treatments: Diagnostic Test: Magnetic Resonance Imaging with Contrast

Study type: Observational

Funder types: Other

Identifiers

NCT07354646

CMR_T1 mapping

Details and patient eligibility

About

The goal of this observational study is to create a comprehensive real-world spectrum of T1 mapping measurements across different heart conditions. We aim to establish reference values for how heart tissue characteristics vary in various diseases, which will help doctors better interpret these advanced MRI measurements in clinical practice. The main questions it aims to answer are:

What are the normal T1 mapping values for different heart diseases, and how do they compare to healthy hearts? Can we use the simpler "native T1" measurement (without contrast dye) instead of the more complex "ECV" measurement (which requires contrast dye) for diagnosis?

Patients with various myocardial conditions will undergo CMR T1 mapping scans. We will analyze the MRI images and clinical records to establish disease-specific reference ranges for T1 mapping parameters, and validate the diagnostic accuracy of T1 mapping

Enrollment: 2,000 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Adult patients (≥18 years) with clinically diagnosed myocardial diseases based on current international guidelines.

2. Specific disease categories include:

   • Cardiomyopathies (HCM, DCM, RCM, ACM)
   • Infiltrative disorders (cardiac amyloidosis, Fabry disease)
   • Inflammatory conditions (acute/chronic myocarditis)
   • Ischemic heart disease (acute/chronic MI)
   • Valvular heart disease (aortic stenosis)
   • Arrhythmic conditions (atrial fibrillation)
   • Metabolic disorders (iron-overload)
   • Neoplastic conditions (cardiac tumors)
   • Congenital heart disease
   • Post-transplant evaluation

3. All diagnoses must be confirmed using established guideline-based criteria:

   • Echocardiographic parameters meeting disease-specific cutoffs
   • Cardiac MRI findings consistent with current consensus criteria
   • Laboratory biomarkers supporting respective diagnoses
   • Histopathological confirmation when clinically indicated

Exclusion criteria

• Presence of multiple cardiomyopathy diseases or risk factors simultaneously
• Contraindications to CMR examination
• Poor image quality precluding accurate T1 mapping analysis
• Incomplete clinical data for definitive diagnosis confirmation
• Pregnancy or lactation
• Inability to provide informed consent

Trial design

2,000 participants in 2 patient groups

Healthy Controls

Description:

CMR criteria: Anatomically intact cardiac structures: LVEF, ventricular volumes, and wall thickness within sex- and BSA-adjusted reference ranges (LVEF ≥55%, LVEDVi \<82 mL/m² for females, \<97 mL/m² for males); Absence of pathological tissue characteristics (negative LGE); Normal hemodynamic profile: Competent valvular function without hemodynamically significant regurgitation or stenosis. Clinical exclusion criteria: No history of coronary artery disease, inflammatory cardiomyopathy, or electrophysiological abnormalities requiring intervention

Treatment:

Diagnostic Test: Magnetic Resonance Imaging with Contrast

Myocardial Diseases

Description:

Patients with various myocardial diseases including Fabry disease, Iron-overload, atrial fibrillation (AF), hypertension, aortic stenosis (AS), chronic myocardial infarction (MI), acute MI, hypertrophic cardiomyopathy (HCM), dilated cardiomyopathy (DCM), restrictive cardiomyopathy (RCM), arrhythmogenic cardiomyopathy (ACM), acute myocarditis, chronic myocarditis, cardiac amyloidosis, cardiac tumor, congenital heart disease, and suspected transplant rejection.

Treatment:

Diagnostic Test: Magnetic Resonance Imaging with Contrast