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Acute Myocardial Infarction Clinical Intelligent Decision Support System

Acute Myocardial Infarction Clinical Intelligent Decision Support System

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07367399
Acronym
AMI-CIDSS
Enrollment
15000
Registered
2026-01-26
Start date
2018-01-01
Completion date
2028-12-31
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction, Clinical Decision Support System, Large Language Models

Brief summary

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.

Interventions

None listed

Sponsors

Beijing Anzhen Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. 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. 2. Patients who have provided written informed consent.

Exclusion criteria

1. patients with a life expectancy \< 12 months due to non-cardiac comorbidities; 2. those with severe cognitive impairment hindering assessment; 3. individuals unable to comply with the long-term follow-up protocol

Design outcomes

Primary

MeasureTime frameDescription
Major Adverse Cardiac and Cerebrovascular Events (MACCE)1 yearA 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

MeasureTime frameDescription
Cardiac Death1 yearDefined as death resulting from a primary cardiac cause (e.g., acute MI, sudden cardiac death, heart failure, or cardiac procedures).
All-cause Mortality1 yearDefined as death due to any cause, encompassing both cardiovascular and non-cardiovascular etiologies.
Non-fatal Recurrent Myocardial Infarction (MI)1 yearDefined 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.
Non-fatal Stroke1 yearConsistent 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).
Unplanned Repeat Revascularization1 yearDefined as any non-elective readmission for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
Rehospitalization for Heart Failure1 yearA 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).
Target Lesion Revascularization (TLR)1 yearDefined 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.
Target Vessel Revascularization (TVR)1 yearDefined 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026