Ischemic Heart Disease (IHD)NCT07351825
CMR Prognostic Markers in Ischemic Heart Disease
An observational study of Ischemic Heart Disease (IHD) and Myocardial Infarction (MI), run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
Ischemic heart disease (IHD) remains a leading cause of morbidity and mortality worldwide. Accurate risk stratification is essential for guiding clinical management and improving long-term outcomes in patients with ischemic myocardial injury. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Heart Disease (IHD), Myocardial Infarction (MI)
- What is being tested?
- Cardiac Magnetic Resonance Imaging
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Dec 2035
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: This observational study includes adult patients with ischemic heart disease who underwent clinically indicated cardiac magnetic resonance imaging as part of routine clinical care at participating centers. The study population represents a real-world cohort with a broad spectrum of ischemic heart disease, including myocardial infarction, and is characterized by comprehensive CMR imaging data, detailed clinical information, and long-term follow-up for cardiovascular outcomes.
Who may be able to join
- Adults (≥18 years of age).
- Patients with ischemic heart disease, including prior or recent myocardial infarction, who underwent clinically indicated cardiac magnetic resonance (CMR) imaging.
- Availability of analyzable CMR images, including but not limited to cine imaging, late gadolinium enhancement (LGE), and parametric mapping sequences (T1 and/or T2 mapping), as applicable.
- Availability of baseline clinical data and longitudinal follow-up information.
Who cannot join
- Poor image quality or incomplete CMR data precluding quantitative analysis.
- Presence of other severe comorbid conditions expected to significantly affect survival or clinical outcomes.
- Missing key clinical outcome data during follow-up.
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 & Peking Union Medical College
Beijing, Beijing Municipality, 100037
Department of Radiology, coolkan@163.com
About this study
Official title: Prognostic Value of Multiparametric Cardiovascular Magnetic Resonance in Patients With Ischemic Heart Disease: A Multicenter Retrospective Cohort Study
Ischemic heart disease (IHD) remains a leading cause of morbidity and mortality worldwide. Accurate risk stratification is essential for guiding clinical management and improving long-term outcomes in patients with ischemic myocardial injury.
Cardiovascular magnetic resonance (CMR) imaging provides comprehensive assessment of myocardial structure, function, and tissue characteristics, enabling detailed evaluation of ischemic injury and its consequences.
Read more
This multicenter, retrospective observational study aims to investigate the prognostic value of multiparametric CMR-derived imaging markers in patients with ischemic heart disease who underwent clinically indicated CMR examinations. Imaging parameters of interest include late gadolinium enhancement (LGE), infarct size, microvascular obstruction (MVO), left ventricular and left atrial strain, and native T1 and T2 mapping values.
Long-term clinical outcomes will be obtained from existing medical records. The primary outcome is major adverse cardiovascular and cerebrovascular events (MACCE), and secondary outcome is cardiovascular death. This study seeks to clarify the role of CMR in long-term risk stratification of patients with ischemic heart disease.
Read the detailed description
This is a multicenter, retrospective observational cohort study based on existing clinical and cardiovascular magnetic resonance (CMR) imaging data. Patients with ischemic heart disease who underwent clinically indicated CMR examinations will be included. Data are derived from multiple centers and span an extended time period, reflecting real-world clinical practice.
CMR examinations were performed as part of routine clinical care. Imaging parameters to be analyzed include late gadolinium enhancement (LGE) for assessment of myocardial scar and ischemic injury, infarct size, presence of microvascular obstruction (MVO), left ventricular and left atrial strain parameters, and native T1 and T2 mapping values when available. Image analysis will be conducted using standardized post-processing methods.
Demographic characteristics, cardiovascular risk factors, treatment strategies, and follow-up data will be collected retrospectively from institutional databases and medical records. The primary outcome of interest is major adverse cardiovascular and cerebrovascular events (MACCE), defined as a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, and unplanned coronary revascularization. The secondary outcome is cardiovascular death.
The primary objective of this study is to evaluate the association between multiparametric CMR-derived imaging markers and long-term clinical outcomes in patients with ischemic heart disease. Secondary objectives include exploring the incremental prognostic value of CMR parameters beyond conventional clinical risk factors and assessing their role in improving individualized risk stratification.
Advanced image analysis techniques, including radiomics and machine learning-based methods, may be applied to CMR images to explore imaging-derived features associated with long-term clinical outcomes.
- Being tested
- Cardiac Magnetic Resonance Imaging
- Keywords
- Ischemic heart disease, Cardiovascular magnetic resonance, Late gadolinium enhancement, Radiomics, Risk stratification, Prognosis
- Medical subject headings
- Myocardial Ischemia, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Magnetic Resonance ImagingDiagnostic test
Cardiac magnetic resonance imaging performed as part of routine clinical care. Imaging data are used for observational research analyses only, without altering clinical management.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Heart Disease Cohort | Adult patients with ischemic heart disease who underwent clinically indicated cardiac magnetic resonance imaging. Imaging, clinical, and follow-up data are collected for observational analyses, including quantitative imaging, outcome assessment, and exploratory modeling. Receives: Diagnostic Test: Cardiac Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular and Cerebrovascular Events
Major adverse cardiovascular and cerebrovascular events (MACCE), defined as a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, and unplanned coronary revascularization. Events are identified through longitudinal clinical follow-up and review of medical records.
Measured: From the date of index clinically indicated cardiac magnetic resonance imaging to the date of first occurrence of a MACCE event, death, or last available clinical follow-up, whichever came first, assessed up to 10 years.
Secondary outcomes (1)
Cardiovascular Death
Death resulting from cardiovascular causes, including myocardial infarction, heart failure, fatal arrhythmia, or sudden cardiac death, as determined by clinical records and follow-up data.
Measured: From the date of index clinically indicated cardiac magnetic resonance imaging to the date of cardiovascular death or last available clinical follow-up, whichever came first, assessed up to 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study startJan 2009
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart Disease (IHD)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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China, Beijing Natural Science Foundation
- Responsible party
- Principal investigator, Minjie Lu, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351825
- Sponsor's protocol ID
- CMR-IHD
- Other IDs
- 82471973, 7242110, 2022-GSP-QZ-5
- Status last verified
- Jan 2026
- First submitted
- 29 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data, including imaging-derived parameters and relevant clinical variables, will be available upon reasonable request. Data sharing will be considered after publication of the primary results and will require approval by the study investigators and the institutional ethics committee, with a data use agreement in place.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Multiparametric Cardiovascular Magnetic Resonance in Patients With Ischemic Heart Disease: A Multicenter Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07351825
- Acronym / sponsor ID
- CMR-IHD
- Keywords
- Ischemic heart disease, Cardiovascular magnetic resonance, Late gadolinium enhancement, Radiomics, Risk stratification, Prognosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China, Beijing Natural Science Foundation
- Study start
- Jan 2009 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 20 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.
Ischemic heart disease (IHD) remains a leading cause of morbidity and mortality worldwide. Accurate risk stratification is essential for guiding clinical management and improving long-term outcomes in patients with ischemic myocardial injury.
Cardiovascular magnetic resonance (CMR) imaging provides comprehensive assessment of myocardial structure, function, and tissue characteristics, enabling detailed evaluation of ischemic injury and its consequences.
This multicenter, retrospective observational study aims to investigate the prognostic value of multiparametric CMR-derived imaging markers in patients with ischemic heart disease who underwent clinically indicated CMR examinations. Imaging parameters of interest include late gadolinium enhancement (LGE), infarct size, microvascular obstruction (MVO), left ventricular and left atrial strain, and native T1 and T2 mapping values.
Long-term clinical outcomes will be obtained from existing medical records. The primary outcome is major adverse cardiovascular and cerebrovascular events (MACCE), and secondary outcome is cardiovascular death. This study seeks to clarify the role of CMR in long-term risk stratification of patients with ischemic heart disease.
Detailed description
This is a multicenter, retrospective observational cohort study based on existing clinical and cardiovascular magnetic resonance (CMR) imaging data. Patients with ischemic heart disease who underwent clinically indicated CMR examinations will be included. Data are derived from multiple centers and span an extended time period, reflecting real-world clinical practice.
CMR examinations were performed as part of routine clinical care. Imaging parameters to be analyzed include late gadolinium enhancement (LGE) for assessment of myocardial scar and ischemic injury, infarct size, presence of microvascular obstruction (MVO), left ventricular and left atrial strain parameters, and native T1 and T2 mapping values when available. Image analysis will be conducted using standardized post-processing methods.
Demographic characteristics, cardiovascular risk factors, treatment strategies, and follow-up data will be collected retrospectively from institutional databases and medical records. The primary outcome of interest is major adverse cardiovascular and cerebrovascular events (MACCE), defined as a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, and unplanned coronary revascularization. The secondary outcome is cardiovascular death.
The primary objective of this study is to evaluate the association between multiparametric CMR-derived imaging markers and long-term clinical outcomes in patients with ischemic heart disease. Secondary objectives include exploring the incremental prognostic value of CMR parameters beyond conventional clinical risk factors and assessing their role in improving individualized risk stratification.
Advanced image analysis techniques, including radiomics and machine learning-based methods, may be applied to CMR images to explore imaging-derived features associated with long-term clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ischemic Heart Disease Cohort | – | Diagnostic Test: Cardiac Magnetic Resonance ImagingAdult patients with ischemic heart disease who underwent clinically indicated cardiac magnetic resonance imaging. Imaging, clinical, and follow-up data are collected for observational analyses, including quantitative imaging, outcome assessment, and exploratory modeling. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This observational study includes adult patients with ischemic heart disease who underwent clinically indicated cardiac magnetic resonance imaging as part of routine clinical care at participating centers. The study population represents a real-world cohort with a broad spectrum of ischemic heart disease, including myocardial infarction, and is characterized by comprehensive CMR imaging data, detailed clinical information, and long-term follow-up for cardiovascular outcomes.
Key inclusion criteria (4 listed)
- Adults (≥18 years of age).
- Patients with ischemic heart disease, including prior or recent myocardial infarction, who underwent clinically indicated cardiac magnetic resonance (CMR) imaging.
- Availability of analyzable CMR images, including but not limited to cine imaging, late gadolinium enhancement (LGE), and parametric mapping sequences (T1 and/or T2 mapping), as applicable.
- Availability of baseline clinical data and longitudinal follow-up information.
Key exclusion criteria (3 listed)
- Poor image quality or incomplete CMR data precluding quantitative analysis.
- Presence of other severe comorbid conditions expected to significantly affect survival or clinical outcomes.
- Missing key clinical outcome data during follow-up.
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 |
|---|---|---|
| Cardiac Magnetic Resonance ImagingCardiac magnetic resonance imaging performed as part of routine clinical care. Imaging data are used for observational research analyses only, without altering clinical management. | Diagnostic test | Ischemic Heart Disease Cohort |
Primary outcome
Major Adverse Cardiovascular and Cerebrovascular Events
Time frame: From the date of index clinically indicated cardiac magnetic resonance imaging to the date of first occurrence of a MACCE event, death, or last available clinical follow-up, whichever came first, assessed up to 10 years.
Major adverse cardiovascular and cerebrovascular events (MACCE), defined as a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, and unplanned coronary revascularization. Events are identified through longitudinal clinical follow-up and review of medical records.
1 secondary outcome
Cardiovascular Death
Time frame: From the date of index clinically indicated cardiac magnetic resonance imaging to the date of cardiovascular death or last available clinical follow-up, whichever came first, assessed up to 10 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 20 Jan 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data, including imaging-derived parameters and relevant clinical variables, will be available upon reasonable request. Data sharing will be considered after publication of the primary results and will require approval by the study investigators and the institutional ethics committee, with a data use agreement in place.
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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 Ischemic Heart Disease (IHD) and Myocardial Infarction (MI), 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 4 inclusion and 3 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 20 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 Zhaoxin Tian (+86 18309820435, tianzx826@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular and Cerebrovascular Events (time frame: From the date of index clinically indicated cardiac magnetic resonance imaging to the date of first occurrence of a MACCE event, death, or last available clinical follow-up, whichever came first, assessed up to 10 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 20 Jan 2026.