NCT07496931

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Mar 2026May 2027

First Submitted

Initial submission to the registry

March 23, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 25, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 23, 2026

Last Update Submit

March 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

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

    1 year

Interventions

For high-risk patients with myocardial infarction, screen and integrate relevant previous prospective, multicenter AMI cohorts, and establish a multicenter, multi-treatment precise high-risk acute myocardial infarction cohort in the Beijing region, with long-term follow-up and supplementation of multidimensional data. Subsequently, based on semantic knowledge-guided cross-modal and cross-timepoint data alignment, use domain adaptation methods to perform fusion modeling of spatiotemporal and modal heterogeneous AMI cohorts. Through multimodal interpretable artificial intelligence models, mine the fused models to complete the construction and validation of an AMI risk prediction model based on spatiotemporally heterogeneous data.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The integrated team covers preliminary cohorts with multi-dimensional data, including multi-center clinical, imaging, and sample information (total cases \>300,000). Based on cohort quality and risk factors, multi-dimensional data is collected on high-risk patients (such as those with previous myocardial infarction, multi-vessel disease, CKD, DM, etc.) to complete the data. The primary endpoint is the time to the first occurrence of acute myocardial infarction within one year after enrollment. Follow-up points are set according to myocardial reinfarction characteristics and needs, and a long-term follow-up plan is formulated (including: frequency of follow-up, follow-up methods, laboratory tests, wearable device data, etc.). Regular follow-up and supplementation of multi-modal data are conducted, ultimately completing a 3,000-case multi-dimensional AMI cohort.

You may qualify if:

  • 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
  • Age ≥18 years
  • Ability to understand and comply with the study protocol and sign the informed consent form

You may not qualify if:

  • 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).
  • Participation in a clinical trial involving drugs or devices within 3 months prior to enrollment.
  • Women who are pregnant, planning to become pregnant, or breastfeeding.
  • Known life-threatening diseases with an expected survival of less than 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2026

First Posted

March 27, 2026

Study Start

March 25, 2026

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share