NCT07354646

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Mar 2020Dec 2026

Study Start

First participant enrolled

March 1, 2020

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

6.6 years

First QC Date

December 29, 2025

Last Update Submit

January 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Ranges of T1 mapping values

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

Study Arms (2)

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

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

Healthy ControlsMyocardial Diseases

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Adult patients (≥18 years) with clinically diagnosed myocardial diseases based on current international guidelines.
  • 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
  • All diagnoses must be confirmed using established guideline-based criteria:
  • Echocardiographic parameters meeting disease-specific cutoffs
  • Cardiac MRI findings consistent with current consensus criteria
  • +2 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Myocardial InfarctionCardiomyopathy, HypertrophicCardiomyopathy, DilatedMyocarditis

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCardiomyopathiesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesCardiomegalyLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Huaying Zhang, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department Director

Study Record Dates

First Submitted

December 29, 2025

First Posted

January 21, 2026

Study Start

March 1, 2020

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations