The Application of T1 Mapping in Real-World

January 12, 2026 updated by: Minjie Lu, Chinese Academy of Medical Sciences, Fuwai Hospital

The Landscape of T1 Mapping for Disease Profiling in a Real-World Cohort

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100000
        • Recruiting
        • Fuwai Hospital, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Controls

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
Diagnostic test: Magnetic Resonance Imaging with Contrast
Participants in this arm undergo a single, standardized cardiac MRI scan with gadolinium-based contrast agent.
Myocardial Diseases
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.
Diagnostic test: Magnetic Resonance Imaging with Contrast
Participants in this arm undergo a single, standardized cardiac MRI scan with gadolinium-based contrast agent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ranges of T1 mapping values
Time Frame: From enrollment until completion of the last T1 mapping examination, assessed up to 5 years
From enrollment until completion of the last T1 mapping examination, assessed up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMR_T1 mapping

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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