The Application of T1 Mapping in Real-World

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorChinese Academy of Medical Sciences, Fuwai Hospital

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Cardiomyopathies (HCM, DCM, RCM, ACM)

Infiltrative disorders (cardiac amyloidosis, Fabry disease)

Inflammatory conditions (acute/chronic myocarditis)

Disqualifiers

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

Trial population

The study population comprises a diverse cohort of patients with a comprehensive spectrum of myocardial conditions, including Fabry disease, iron overload, atrial fibrillation, hypertension, aortic stenosis, chronic and acute myocardial infarction, hypertrophic, dilated, restrictive, and arrhythmogenic cardiomyopathies, acute and chronic myocarditis, cardiac amyloidosis, cardiac tumors, congenital heart disease, and cases of suspected transplant rejection. This population represents a wide array of pathophysiological processes affecting the myocardium, ensuring broad clinical relevance and generalizability of the study findings.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Magnetic Resonance Imaging with Contrast

    Diagnostic test

    Participants in this arm undergo a single, standardized cardiac MRI scan with gadolinium-based contrast agent.

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: Healthy Controls1 intervention
Group B: Myocardial Diseases1 intervention

Trial outcomes

Primary outcomes

1

Ranges of T1 mapping values

Time frame
From enrollment until completion of the last T1 mapping examination, assessed up to 5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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