Myocardial Infarction (MI)NCT07250152
Enhanced Prediction Model for Major Adverse Events Following Acute Myocardial Infarction
An observational study of Myocardial Infarction (MI), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Acute myocardial infarction (AMI) remains a leading cause of mortality worldwide. Although early revascularization has markedly improved short-term outcomes, the incidence of major adverse cardiovascular events after the index event remains unacceptably high, posing a formidable clinical challenge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction (MI)
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- How many people
- 1,544 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 31 Dec 2028
- How long will I take part?
- 60 Months
- 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: Patients with myocardial infarction
Who may be able to join
- Age ≥18 years old
- Presented with myocardial infarction, including NSTEMI and STEMI
- Undergoing successful percutaneous coronary intervention.
Who cannot join
- Subjects who decline protocol-mandated follow-up or withhold informed consent.
- Individuals whose expected survival is < 1 year.
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
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Acute myocardial infarction (AMI) remains a leading cause of mortality worldwide. Although early revascularization has markedly improved short-term outcomes, the incidence of major adverse cardiovascular events after the index event remains unacceptably high, posing a formidable clinical challenge. Contemporary risk-stratification instruments rely predominantly on a restricted set of conventional clinical variables and therefore fail to capture the full spectrum of individual pathophysiological complexity. To overcome these limitations, the present investigation aims to develop a post-AMI prognostic model that integrates comprehensive multimodal data.
- Conditions
- Myocardial Infarction (MI)
- Being tested
- Percutaneous coronary intervention
- Keywords
- myocardial infarction
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionProcedure or surgery
Percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| MI group | Patients who present with myocardial infarction and undergo successful percutaneous coronary intervention will be eligible for enrollment. Receives: Procedure: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent myocardial infarction or cardiac death
Patients received recurrent myocardial infarction or cardiac death
Measured: At 24-month Follow-up
Diagnostic performance
Diagnostic performance of the AI-driven multimodal predictive model: area under the receiver-operating characteristic curve (AUC), sensitivity, specificity, overall accuracy, positive predictive value (PPV), and negative predictive value (NPV).
Measured: At 24-month follow-up
MACE at 24 months
Major adverse cardiovascular events, defined as a compisite of cardiac death, myocardial infarction, target vessel revascularization.
Measured: At 24-month follow-up
Secondary outcomes (1)
MACE at 60 months
Major adverse cardiovascular events, defined as a compisite of cardiac death, myocardial infarction, target vessel revascularization.
Measured: At 60-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2028 (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 Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 1,544 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250152
- Sponsor's protocol ID
- 2025-1224
- Status last verified
- Sep 2025
- First submitted
- 18 Nov 2025
- Last updated
- 26 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 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Prediction Model for Major Adverse Events Following Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT07250152
- Acronym / sponsor ID
- 2025-1224
- Conditions
- Myocardial Infarction (MI)
- Keywords
- myocardial infarction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,544 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 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.
Acute myocardial infarction (AMI) remains a leading cause of mortality worldwide. Although early revascularization has markedly improved short-term outcomes, the incidence of major adverse cardiovascular events after the index event remains unacceptably high, posing a formidable clinical challenge. Contemporary risk-stratification instruments rely predominantly on a restricted set of conventional clinical variables and therefore fail to capture the full spectrum of individual pathophysiological complexity. To overcome these limitations, the present investigation aims to develop a post-AMI prognostic model that integrates comprehensive multimodal data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MI group | – | Procedure: Percutaneous coronary interventionPatients who present with myocardial infarction and undergo successful percutaneous coronary intervention will be eligible for enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with myocardial infarction
Key inclusion criteria (3 listed)
- Age ≥18 years old
- Presented with myocardial infarction, including NSTEMI and STEMI
- Undergoing successful percutaneous coronary intervention.
Key exclusion criteria (2 listed)
- Subjects who decline protocol-mandated follow-up or withhold informed consent.
- Individuals whose expected survival is < 1 year.
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 |
|---|---|---|
| Percutaneous coronary interventionPercutaneous coronary intervention | Procedure or surgery | MI group |
Primary outcome
Recurrent myocardial infarction or cardiac death
Time frame: At 24-month Follow-up
Patients received recurrent myocardial infarction or cardiac death
Diagnostic performance
Time frame: At 24-month follow-up
Diagnostic performance of the AI-driven multimodal predictive model: area under the receiver-operating characteristic curve (AUC), sensitivity, specificity, overall accuracy, positive predictive value (PPV), and negative predictive value (NPV).
MACE at 24 months
Time frame: At 24-month follow-up
Major adverse cardiovascular events, defined as a compisite of cardiac death, myocardial infarction, target vessel revascularization.
1 secondary outcome
MACE at 60 months
Time frame: At 60-month follow-up
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 26 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.
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), run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 3 inclusion and 2 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 26 Nov 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 Jun Jiang, MD (+86 15657125311, 21918219@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent myocardial infarction or cardiac death (time frame: At 24-month Follow-up). 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 26 Nov 2025.