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RecruitingNCT07354646Updated Nov 9, 2026

The Application of T1 Mapping in Real-World

An observational study in Myocardial Infarction (MI), Hypertrophic Cardiomyopathy (HCM) and Dilated Cardiomyopathy (DCM), sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-11-09.

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

From the registry’s dates

  • Started Mar 2020; still recruiting 6 years 8 months later.
Updated Nov 9, 2026Primary completion movedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Sex
All
01

Study summary

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

02

Conditions studied

  • Myocardial Infarction (MI)
  • Hypertrophic Cardiomyopathy (HCM)
  • Dilated Cardiomyopathy (DCM)
  • Arrhythmogenic Cardiomyopathy
  • Myocarditis
03

In context

Myocardial Infarction

2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 568 across 814 observational studies indexed under Myocardial Infarction.

Browse Myocardial Infarction 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.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

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

  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

Exclusion Criteria:

  • Presence of multiple cardiomyopathy diseases or risk factors simultaneously
  • to CMR examination
  • Poor image quality precluding accurate T1 mapping analysis
  • Incomplete clinical data for definitive diagnosis confirmation
  • Pregnancy or lactation
  • Inability to provide
Terms in these criteria, in plain language(2)

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • Diagnostic testMagnetic Resonance Imaging with Contrast

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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Oct 1, 2026→Dec 1, 2026
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    Primary completion Oct 1, 2026→Dec 1, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07354646
Responsible party
Minjie Lu (Department Director, Chinese Academy of Medical Sciences, Fuwai Hospital) — Principal investigator
First posted
Jan 21, 2026
Start date
Mar 1, 2020
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Nov 9, 2026

Study contacts

Huaying Zhang, Doctor
Contact
zhy_dreamer@163.com
86 13695310578
View the source record on ClinicalTrials.gov ↗

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