Enhanced Prediction Model for Major Adverse Events Following Acute Myocardial Infarction

November 18, 2025 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1544

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The Second Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with myocardial infarction

Description

Inclusion Criteria:

  1. Age ≥18 years old
  2. Presented with myocardial infarction, including NSTEMI and STEMI
  3. Undergoing successful percutaneous coronary intervention.

Exclusion Criteria:

  1. Subjects who decline protocol-mandated follow-up or withhold informed consent.
  2. Individuals whose expected survival is < 1 year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MI group
Patients who present with myocardial infarction and undergo successful percutaneous coronary intervention will be eligible for enrollment.
Procedure: Percutaneous coronary intervention
Percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent myocardial infarction or cardiac death
Time Frame: At 24-month Follow-up
Patients received recurrent myocardial infarction or cardiac death
At 24-month Follow-up
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).
At 24-month follow-up
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.
At 24-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE at 60 months
Time Frame: At 60-month follow-up
Major adverse cardiovascular events, defined as a compisite of cardiac death, myocardial infarction, target vessel revascularization.
At 60-month follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE according to pre-specified subgroups
Time Frame: At 24- and 60-month follow-up
MACE stratified by sex, diabetes status, and chronic kidney disease (CKD) status.
At 24- and 60-month follow-up
MACE according to physiological status
Time Frame: At 24- and 60-month follow-up
MACE prediction integrating physiological metrics-angiographic FFR, IMR, MRR, and CFR-of the culprit and non-culprit coronary arteries.
At 24- and 60-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-1224

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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