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NCT Number: NCT07250152

Enhanced Prediction Model for Major Adverse Events Following Acute Myocardial Infarction

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.

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Key information

Conditions

Myocardial Infarction (MI) Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Percutaneous coronary intervention

Procedure

Percutaneous coronary intervention

Primary outcomes

  1. Recurrent myocardial infarction or cardiac death

    Time frame: At 24-month Follow-up

    Patients received recurrent myocardial infarction or cardiac death

  2. 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).

  3. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jun Jiang, MD

CONTACT

[email protected]

+86 15657125311

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 26, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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