Ischemic Mitral RegurgitationChina-IMRNCT07230756
Coronary Heart Disease Complicated With Ischemic Mitral Regurgitation in China
An observational study of Ischemic Mitral Regurgitation and Coronary Heart Disease (CHD), run by China National Center for Cardiovascular Diseases.
Trial summary
This project will rely on the established multi-center cooperation platform for total valve disease and based on the Carpentier classification, which is newly proposed and widely recognized by the academic community, and will specifically target the population with coronary heart disease combined with Ischemic Mitral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Mitral Regurgitation, Coronary Heart Disease (CHD)
- How many people
- 6,000 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2025to 31 Dec 2029
- How long will I take part?
- 2 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with coronary heart disease combined with ischemic mitral regurgitation
Who may be able to join
- Age ≥18 years, secondary mitral regurgitation discovered during outpatient visit or hospitalization;
- Have definite coronary heart disease
- Cardiac ultrasound: consistent with mitral regurgitation caused by myocardial ischemia or myocardial infarction:
- Segmental wall motion abnormality or
- Mitral regurgitation is consistent with Carpentier type IIIb (eccentric regurgitation)
- Cardiac ultrasound prompts: moderate or above ischemic mitral regurgitation
Who cannot join
- Patients within the past year or currently participating in other clinical studies;
- Primary mitral regurgitation (such as mitral valve prolapse, perforation, chordae tendineae rupture, etc.);
- Dilated cardiomyopathy, hypertrophic cardiomyopathy and other diseases;
- Moderate and above aortic stenosis/regurgitation, mitral stenosis, tricuspid stenosis, etc.;
- Patients who have undergone cardiac valve intervention/surgery.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Cohort Study of Coronary Heart Disease Complicated With Ischemic Mitral Regurgitation in China
This project will rely on the established multi-center cooperation platform for total valve disease and based on the Carpentier classification, which is newly proposed and widely recognized by the academic community, and will specifically target the population with coronary heart disease combined with Ischemic Mitral Regurgitation（IMR） to conduct a nationwide, multi-center, single valve disease, prospective cohort. Research. From November 2025 to December 2025, 6,000 patients with coronary heart disease combined with moderate or above IMR were consecutively selected from outpatients or inpatients in 21 regional medical centers across the country, and clinical characteristics, imaging data, and serology were collected. Information, drug/surgical intervention status and clinical outcome indicators were included in the clinical follow-up at baseline, 3 months, 6 months, 12 months and 24 months respectively. The main research objectives are to describe the disease characteristics, treatment status and clinical outcomes of coronary heart disease patients with IMR; to evaluate the current application status of GDMT strategies in IMR diagnosis and treatment practice and its impact on mid- and long-term prognosis. The secondary research objectives are to identify factors affecting prognosis, construct a risk stratification model for mid- and long-term prognosis, and discover new molecular markers.
This project will for the first time construct the world's largest clearly defined cohort of coronary heart disease combined with IMR. Its research results can provide high-quality data and decision-making basis for precise diagnosis and treatment of IMR populations. Therefore, this project has important scientific research value and clinical guidance significance.
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GDMT Group | Not described | |
| Non-GDMT Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of heart failure hospitalization and all-cause death
Time to first occurrence of either hospitalization for heart failure or death from any cause, whichever occurs first.
Measured: 3, 6, 12, 24 months
Secondary outcomes (3)
Change in mitral regurgitation severity
Change in mitral regurgitation (MR) grade from baseline to 24 months as assessed by echocardiography, measured using standard semiquantitative grading (none, mild, moderate, severe).
Measured: 3 month, 6 month, 12 month, 24 month
All-cause mortality
Incidence of death due to any cause during the follow-up period
Measured: 3 month, 6 month, 12 month, 24 month
Hospitalization for heart failure
Incidence of unplanned hospital admission primarily for management of heart failure symptoms.
Measured: 3, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start10 Nov 2025 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- 6,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Erli Zhang, MD, PhD, Principal investigator, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230756
- Sponsor's protocol ID
- 2024-GSP-TJ-7
- Acronym
- China-IMR
- Status last verified
- Dec 2024
- First submitted
- 2 Jan 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Coronary Heart Disease Complicated With Ischemic Mitral Regurgitation in China
- ClinicalTrials.gov ID
- NCT07230756
- Acronym / sponsor ID
- China-IMR / 2024-GSP-TJ-7
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 10 Nov 2025 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 17 Nov 2025 (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.
This project will rely on the established multi-center cooperation platform for total valve disease and based on the Carpentier classification, which is newly proposed and widely recognized by the academic community, and will specifically target the population with coronary heart disease combined with Ischemic Mitral Regurgitation（IMR） to conduct a nationwide, multi-center, single valve disease, prospective cohort. Research. From November 2025 to December 2025, 6,000 patients with coronary heart disease combined with moderate or above IMR were consecutively selected from outpatients or inpatients in 21 regional medical centers across the country, and clinical characteristics, imaging data, and serology were collected. Information, drug/surgical intervention status and clinical outcome indicators were included in the clinical follow-up at baseline, 3 months, 6 months, 12 months and 24 months respectively. The main research objectives are to describe the disease characteristics, treatment status and clinical outcomes of coronary heart disease patients with IMR; to evaluate the current application status of GDMT strategies in IMR diagnosis and treatment practice and its impact on mid- and long-term prognosis. The secondary research objectives are to identify factors affecting prognosis, construct a risk stratification model for mid- and long-term prognosis, and discover new molecular markers.
This project will for the first time construct the world's largest clearly defined cohort of coronary heart disease combined with IMR. Its research results can provide high-quality data and decision-making basis for precise diagnosis and treatment of IMR populations. Therefore, this project has important scientific research value and clinical guidance significance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDMT Group | – | – |
| Non-GDMT Group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with coronary heart disease combined with ischemic mitral regurgitation
Key inclusion criteria (6 listed)
- Age ≥18 years, secondary mitral regurgitation discovered during outpatient visit or hospitalization;
- Have definite coronary heart disease
- Cardiac ultrasound: consistent with mitral regurgitation caused by myocardial ischemia or myocardial infarction:
- Cardiac ultrasound prompts: moderate or above ischemic mitral regurgitation
Key exclusion criteria (5 listed)
- Patients within the past year or currently participating in other clinical studies;
- Primary mitral regurgitation (such as mitral valve prolapse, perforation, chordae tendineae rupture, etc.);
- Dilated cardiomyopathy, hypertrophic cardiomyopathy and other diseases;
- Moderate and above aortic stenosis/regurgitation, mitral stenosis, tricuspid stenosis, etc.;
- Patients who have undergone cardiac valve intervention/surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite endpoint of heart failure hospitalization and all-cause death
Time frame: 3, 6, 12, 24 months
Time to first occurrence of either hospitalization for heart failure or death from any cause, whichever occurs first.
3 secondary outcomes
Change in mitral regurgitation severity
Time frame: 3 month, 6 month, 12 month, 24 month
All-cause mortality
Time frame: 3 month, 6 month, 12 month, 24 month
Hospitalization for heart failure
Time frame: 3, 6, 12, 24 months
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 17 Nov 2025.
- 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.
Erli Zhang, MD, PhD principal investigator
China National Center for Cardiovascular Diseases
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Mitral Regurgitation and Coronary Heart Disease (CHD), run by China National Center for Cardiovascular Diseases.
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Erli Zhang, MD, PhD (+86-18500853301, zhangerli@fuaihospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of heart failure hospitalization and all-cause death (time frame: 3, 6, 12, 24 months). 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 17 Nov 2025.