Premature Coronary Heart DiseaseNCT07004452
Multi-modal Adverse Events Prediction for Premature Coronary Heart Disease Trial: MAP-CHD Trial
An observational study of Premature Coronary Heart Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
The goal of this observational cohort study is to establish a risk prediction model for adverse events in Chinese individuals under 45 years old with premature coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Premature Coronary Heart Disease
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2025to Jul 2027
- 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Eligible participants are CAD patients aged 18-45 years confirmed by coronary angiography or other imaging modalities, including those with stable/unstable angina or myocardial infarction.
Who may be able to join
- Age 18-45 years;
- Clinically confirmed CAD with ≥50% luminal stenosis in at least one major coronary artery or significant branch, verified by coronary angiography;
- For acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) patients: clinical stability meeting discharge criteria post-treatment;
- Voluntary participation with signed informed consent.
Who cannot join
- Heart transplant recipients;
- Severe systemic comorbidities with life expectancy <1 year;
- Previous enrollment in other drug/device clinical trials without completing the primary endpoint observation period;
- Inability to comply with follow-up (e.g., dementia, severe psychiatric disorders).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this observational cohort study is to establish a risk prediction model for adverse events in Chinese individuals under 45 years old with premature coronary artery disease. The main questions it aims to answer are:
- What are the major risk factors for poor prognosis in Chinese patients with premature coronary artery disease?
- What is the difference in the prognosis of patients with premature coronary heart disease with different phenotypes? Participants taking no mandatory intervention will be followed up for 2 year, with blood tests at 1 year and outpatient or telephone interviews at other timepoints.
- Conditions
- Premature Coronary Heart Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
MACCE, defined as a composite of cardiac death, MI, ischemic stroke, and repeat revascularization
Measured: 2 years
Sensitivity for 2-year MACCE prediction
For the validation cohort
Measured: 2 years
Specificity for 2-year MACCE prediction
For the validation cohort
Measured: 2 years
Secondary outcomes (9)
Incidence of death (cardiovascular, noncardiovascular, and undetermined) at 1 m, 6 m, 1 y and 2 y
For the development cohort
Measured: 2 years
Incidence of MI (target vessel related and non-target vessel related or Culprit and non-culprit lesion-related) at 1 m, 6 m, 1 y and 2 y
For the development cohort
Measured: 2 years
Incidence of all revascularizations (ischemia driven vs. non-ischemia driven; Target vs. non-target vessel; Culprit vs. non-culprit lesion) at 1 m, 6 m, 1 y and 2 y
For the development cohort
Measured: 2 years
Incidence of definite or probable stent thrombosis during the acute, subacute, late, and very late phase according to the ARC-2 criteria
For the development cohort
Measured: 2 years
Incidence of stroke (ischemic and hemorrhagic stroke) at 1 m, 6 m, 1 y and 2 y
For the development cohort
Measured: 2 years
Incidence of bleeding events defined as BARC type ≥2 at 1 m, 6 m, 1 y and 2 y
For the development cohort
Measured: 2 years
Area under the ROC curve (AUC)
For the validation cohort
Measured: 2 years
Positive predictive value (PPV)
For the validation cohort
Measured: 2 years
Negative predictive value (NPV)
For the validation cohort
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start31 Mar 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Coronary Heart DiseaseStudies 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
- 5,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004452
- Sponsor's protocol ID
- 2023ZD0504003
- Status last verified
- May 2025
- First submitted
- 27 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-modal Adverse Events Prediction for Premature Coronary Heart Disease Trial: MAP-CHD Trial
- ClinicalTrials.gov ID
- NCT07004452
- Acronym / sponsor ID
- 2023ZD0504003
- Conditions
- Premature Coronary Heart Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 4 Jun 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.
The goal of this observational cohort study is to establish a risk prediction model for adverse events in Chinese individuals under 45 years old with premature coronary artery disease. The main questions it aims to answer are:
- What are the major risk factors for poor prognosis in Chinese patients with premature coronary artery disease?
- What is the difference in the prognosis of patients with premature coronary heart disease with different phenotypes? Participants taking no mandatory intervention will be followed up for 2 year, with blood tests at 1 year and outpatient or telephone interviews at other timepoints.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Eligible participants are CAD patients aged 18-45 years confirmed by coronary angiography or other imaging modalities, including those with stable/unstable angina or myocardial infarction.
Key inclusion criteria (4 listed)
- Age 18-45 years;
- Clinically confirmed CAD with ≥50% luminal stenosis in at least one major coronary artery or significant branch, verified by coronary angiography;
- For acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) patients: clinical stability meeting discharge criteria post-treatment;
- Voluntary participation with signed informed consent.
Key exclusion criteria (4 listed)
- Heart transplant recipients;
- Severe systemic comorbidities with life expectancy <1 year;
- Previous enrollment in other drug/device clinical trials without completing the primary endpoint observation period;
- Inability to comply with follow-up (e.g., dementia, severe psychiatric disorders).
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
MACCE, defined as a composite of cardiac death, MI, ischemic stroke, and repeat revascularization
Time frame: 2 years
Sensitivity for 2-year MACCE prediction
Time frame: 2 years
For the validation cohort
Specificity for 2-year MACCE prediction
Time frame: 2 years
For the validation cohort
9 secondary outcomes
Incidence of death (cardiovascular, noncardiovascular, and undetermined) at 1 m, 6 m, 1 y and 2 y
Time frame: 2 years
Incidence of MI (target vessel related and non-target vessel related or Culprit and non-culprit lesion-related) at 1 m, 6 m, 1 y and 2 y
Time frame: 2 years
Incidence of all revascularizations (ischemia driven vs. non-ischemia driven; Target vs. non-target vessel; Culprit vs. non-culprit lesion) at 1 m, 6 m, 1 y and 2 y
Time frame: 2 years
Incidence of definite or probable stent thrombosis during the acute, subacute, late, and very late phase according to the ARC-2 criteria
Time frame: 2 years
Incidence of stroke (ischemic and hemorrhagic stroke) at 1 m, 6 m, 1 y and 2 y
Time frame: 2 years
Incidence of bleeding events defined as BARC type ≥2 at 1 m, 6 m, 1 y and 2 y
Time frame: 2 years
Area under the ROC curve (AUC)
Time frame: 2 years
Positive predictive value (PPV)
Time frame: 2 years
Negative predictive value (NPV)
Time frame: 2 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 4 Jun 2025.
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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 Premature Coronary Heart Disease, run by China National Center for Cardiovascular Diseases 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 4 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 4 Jun 2025. 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 Jingjing Xu (86 134-260-50924, 335418449@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACCE, defined as a composite of cardiac death, MI, ischemic stroke, and repeat revascularization (time frame: 2 years). The study lists 3 primary outcomes in all. 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 4 Jun 2025.