Myocardial Infarction (MI)NCT07354646
The Application of T1 Mapping in Real-World
An observational study of Myocardial Infarction (MI) and Hypertrophic Cardiomyopathy (HCM), run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction (MI), Hypertrophic Cardiomyopathy (HCM), Dilated Cardiomyopathy (DCM)
- What is being tested?
- Magnetic Resonance Imaging with Contrast
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 1 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Show all 17Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100000
Huaying Zhang, Doctor, 86 13695310578, zhy_dreamer@163.com
About this study
Official title: 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
- Conditions
- Myocardial Infarction (MI), Hypertrophic Cardiomyopathy (HCM), Dilated Cardiomyopathy (DCM), Arrhythmogenic Cardiomyopathy, Myocarditis
- Being tested
- Magnetic Resonance Imaging with Contrast
- Medical subject headings
- Myocardial Infarction, Cardiomyopathy, Hypertrophic, Cardiomyopathy, Dilated, Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging with ContrastDiagnostic test
Participants in this arm undergo a single, standardized cardiac MRI scan with gadolinium-based contrast agent.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Diagnostic Test: Magnetic Resonance Imaging with Contrast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ranges of T1 mapping values
Measured: From enrollment until completion of the last T1 mapping examination, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Mar 2020
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction (MI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minjie Lu, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354646
- Sponsor's protocol ID
- CMR_T1 mapping
- Status last verified
- Jan 2026
- First submitted
- 29 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Individual data sharing
- No