Construction and Analysis of a Risk Prediction Model for Acute Myocardial Infarction Based on Spatiotemporal Heterogeneous Data
Trial ID: NCT07496931
Status: NOT_YET_RECRUITING
Study type: OBSERVATIONAL
Start date: 2026-03-25
Completion date: 2027-05-31
Sponsor: Beijing Anzhen Hospital
Conditions: Acute Myocardial Infarction (AMI)
Interventions: Acute Myocardial Infarction Risk Prediction Model
Enrollment: 3000
Age range: 18 Years - 85 Years
Sex: ALL

Summary:
Acute myocardial infarction (AMI), as the leading cause of death among cardiovascular diseases, has its diagnosis and treatment efficiency directly affecting survival. Although the current diagnosis and treatment system has significantly improved in-hospital outcomes, delays in seeking medical care due to patients' insufficient awareness and out-of-hospital deaths are common, representing the biggest bottleneck in improving diagnostic and treatment capabilities. This study takes intelligent-assisted diagnosis of AMI as the entry point and proposes a technical approach that combines a deep learning algorithm based on 12-lead electrocardiograms with wearable monitoring devices. By utilizing morphological feature extraction and deep learning models, it aims to achieve early identification and warning of AMI. The study plans to build a multi-center AMI long-term follow-up cohort covering the Beijing area based on spatiotemporal heterogeneous data. By integrating and forming a precise high-risk cohort of 3,000 acute myocardial infarction cases, it seeks to construct an AMI risk prediction model that combines deep learning with a retrieval-augmented generative expert system, breaking through bottlenecks in ECG recognition and temporal prediction, enhancing model generalization and transferability. Ultimately, it will support the application of wearable devices, shorten pre-hospital delays, achieve early warning and precise diagnosis of AMI, reduce reinfarction and cardiac-related mortality, and carry significant clinical and public health importance.

Eligibility criteria:
Inclusion Criteria:

1. High-risk population for acute myocardial infarction, previously confirmed by cardiac imaging to have coronary artery disease and at least one of the following risk factors:

   * Multivessel coronary artery disease (defined as ≥50% stenosis in at least 2 coronary artery regions, including the left main coronary artery)
   * Previous myocardial infarction
   * Patients with diabetes currently undergoing glucose-lowering treatment
   * Chronic kidney disease (CKD) defined as an estimated glomerular filtration rate \<60 mL/min/1.73 m² with a known history of chronic kidney disease or biomarkers indicating chronic kidney damage
   * Peripheral artery disease, defined as any of the following: ankle-brachial index \<0.85; \>50% stenosis in lower limb arteries confirmed by angiography (invasive or non-invasive) or duplex ultrasound; limb amputation, peripheral artery bypass, or vascular surgery (such as angioplasty or endarterectomy) secondary to ischemia
2. Age ≥18 years
3. Ability to understand and comply with the study protocol and sign the informed consent form

Exclusion Criteria:

1. Researchers consider diseases or conditions that are not suitable for participation in this study (such as mental illness, significant cognitive impairment, neurodegenerative diseases, advanced malignant tumors) or situations (such as inability to communicate well with researchers in the local language, unwillingness to comply with study procedures/instructions, inability to understand study-specific training, physically fragile and vulnerable subjects).
2. Participation in a clinical trial involving drugs or devices within 3 months prior to enrollment.
3. Women who are pregnant, planning to become pregnant, or breastfeeding.
4. Known life-threatening diseases with an expected survival of less than 12 months.

Outcomes:
The time of the first occurrence of acute myocardial infarction (AMI) within 1 year after enrollment.