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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Landscape of T1 Mapping for Disease Profiling in a Real-World Cohort
- ClinicalTrials.gov ID
- NCT07354646
- Acronym / sponsor ID
- CMR_T1 mapping
- Conditions
- Myocardial Infarction (MI), Hypertrophic Cardiomyopathy (HCM), Dilated Cardiomyopathy (DCM), Arrhythmogenic Cardiomyopathy, Myocarditis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Diagnostic Test: Magnetic Resonance Imaging with ContrastCMR 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 |
| Myocardial Diseases | – | Diagnostic Test: Magnetic Resonance Imaging with ContrastPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (17 listed)
- Adult patients (≥18 years) with clinically diagnosed myocardial diseases based on current international guidelines.
- Specific disease categories include:
- All diagnoses must be confirmed using established guideline-based criteria:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging with ContrastParticipants in this arm undergo a single, standardized cardiac MRI scan with gadolinium-based contrast agent. | Diagnostic test | Healthy Controls, Myocardial Diseases |
Primary outcome
Ranges of T1 mapping values
Time frame: From enrollment until completion of the last T1 mapping examination, assessed up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huaying Zhang, Doctor (86 13695310578, zhy_dreamer@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ranges of T1 mapping values (time frame: From enrollment until completion of the last T1 mapping examination, assessed up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.