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NCT Number: NCT07354646

The Application of T1 Mapping in Real-World

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

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Treatment and study plan

Magnetic Resonance Imaging with Contrast

Diagnostic Test

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Huaying Zhang, Doctor

CONTACT

[email protected]

86 13695310578

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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