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NCT Number: NCT07367399

Acute Myocardial Infarction Clinical Intelligent Decision Support System

Acute Myocardial Infarction (AMI) remains the leading cause of cardiovascular mortality globally. In China, while the incidence of AMI is escalating at an annual rate of 5.2%, significant clinical challenges persist: diagnostic delays in primary care facilities exceed 40%, and the "Door-to-Balloon" (D2B) compliance rate in tertiary hospitals stagnates at a mere 65%. These figures underscore systemic deficiencies, including inefficient emergency response, regional resource disparities, and fragmented longitudinal care. Although Large Language Models (LLMs) provide a transformative technical foundation for AMI management, their clinical translation is hindered by critical bottlenecks, such as non-standardized data interfaces, limited model interpretability, inadequate hardware infrastructure at the grassroots level, and the inherent tension between data privacy and training requirements.

This research proposes a comprehensive implementation strategy for an AI-driven intelligent decision-making system for AMI. On a theoretical level, the study establishes a tripartite framework of "Technological Adaptation, Scenario Implementation, and Safeguard Mechanisms." By introducing a data governance scheme based on federated learning and multimodal fusion, and constructing a "Technical-Clinical-Economic" multidimensional evaluation model, this work bridges the theoretical divide between advanced technology and clinical practice. On a practical level, the study develops adaptive gateways and lightweight models to facilitate pervasive deployment in resource-constrained settings, optimizes the full-cycle clinical workflow to improve patient outcomes, and provides a scalable, replicable pathway for implementation.

Focusing on four core challenges-technological compatibility, clinical workflow integration, the balance between privacy and performance, and the establishment of scientific evaluation systems-this research aims to surmount existing translation barriers. It seeks to enhance the quality and efficiency of AMI care while providing a seminal reference for the clinical transformation of AI in other medical specialties.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Acute Myocardial Infarction Clinical Decision Support System Large Language Models

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Anzhen Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients meeting the diagnostic criteria for acute myocardial infarction (AMI). Acute Myocardial Infarction (AMI) encompasses both ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI).

According to the Fourth Universal Definition of Myocardial Infarction, myocardial injury is defined as the detection of an elevated cardiac troponin (cTn) value above the 99th percentile upper reference limit (URL). The injury is considered acute if there is a rise and/or fall of cTn values.

The clinical definition of myocardial infarction (MI) requires the presence of acute myocardial injury, confirmed by abnormal cardiac biomarkers, in the setting of evidence of acute myocardial ischemia. Clinical evidence of ischemia includes at least one of the following:

①Symptoms of myocardial ischemia;

②New ischemic ECG changes;

③Development of pathological Q waves;

④Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology;

⑤Identification of a coronary thrombus by angiography or autopsy.

  • Patients who have provided written informed consent.

Exclusion criteria

  • patients with a life expectancy < 12 months due to non-cardiac comorbidities;
  • those with severe cognitive impairment hindering assessment;
  • individuals unable to comply with the long-term follow-up protocol

Treatment and study plan

Primary outcomes

  1. Major Adverse Cardiac and Cerebrovascular Events (MACCE)

    Time frame: 1 year

    A composite endpoint comprising cardiac death, all-cause mortality, malignant arrhythmia, non-fatal recurrent myocardial infarction (MI), non-fatal stroke, unplanned repeat revascularization, and rehospitalization for heart failure.

Secondary outcomes

  1. Cardiac Death

    Time frame: 1 year

    Defined as death resulting from a primary cardiac cause (e.g., acute MI, sudden cardiac death, heart failure, or cardiac procedures).

  2. All-cause Mortality

    Time frame: 1 year

    Defined as death due to any cause, encompassing both cardiovascular and non-cardiovascular etiologies.

  3. Non-fatal Recurrent Myocardial Infarction (MI)

    Time frame: 1 year

    Defined as a new myocardial infarction occurring after the index event. This includes three distinct patterns: extension of the original infarct, infarction in a region adjacent to the initial site, or a new infarction at a site distant from the original lesion.

  4. Non-fatal Stroke

    Time frame: 1 year

    Consistent with the World Health Organization (WHO) definition, stroke is defined as a focal (or global) neurological deficit caused by vascular injury persisting for more than 24 hours. This includes both ischemic and hemorrhagic stroke (intracerebral, intraventricular, and subarachnoid hemorrhage).

  5. Unplanned Repeat Revascularization

    Time frame: 1 year

    Defined as any non-elective readmission for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).

  6. Rehospitalization for Heart Failure

    Time frame: 1 year

    A complex clinical syndrome resulting from structural and/or functional cardiac abnormalities that lead to reduced cardiac output and/or elevated intracardiac pressures at rest or during stress. Diagnosis requires inpatient treatment for typical symptoms and signs, such as dyspnea, fatigue, and fluid retention (e.g., pulmonary congestion, systemic venous congestion, or peripheral edema).

  7. Target Lesion Revascularization (TLR)

    Time frame: 1 year

    Defined as repeat percutaneous intervention or bypass surgery involving the target lesion, which includes the stented segment plus the 5 mm proximal and distal margins. The necessity for revascularization is indicated by: (1) target lesion stenosis >50% in the presence of objective evidence of ischemia; or (2) target lesion stenosis >70% regardless of clinical symptoms.

  8. Target Vessel Revascularization (TVR)

    Time frame: 1 year

    Defined as any repeat percutaneous intervention or bypass surgery performed on any segment of the target vessel, including the target lesion, the proximal and distal segments of the main epicardial artery, and all of its branches.

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Acronym: AMI-CIDSS

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

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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