NCT07277400

Brief Summary

Objective: This study aims to develop and test a novel artificial intelligence-based prediction model. This model will integrate cardiac magnetic resonance imaging and clinical data to predict the long-term risk of major adverse cardiovascular events in patients who have undergone emergency percutaneous coronary intervention for ST-segment elevation myocardial infarction. Description: This study plans to enroll patients with STEMI who have received primary PCI. Approximately one week after the procedure, patients will undergo a cardiac magnetic resonance scan. Concurrently, we will collect patients' basic information, blood test results during treatment, and procedural records. Thereafter, patients will be followed up regularly (every six months) to record the occurrence of any major adverse cardiac events, such as cardiovascular death, recurrent myocardial infarction, hospitalization for heart failure, or unplanned repeat revascularization.All collected data, including clinical data and analyzed cardiac MR images, will be used to construct a multimodal deep learning model. The model will learn to identify features associated with future cardiac problems. The accuracy of the model will be tested and validated in different patient groups. Potential Impact: If successful, this prediction tool could assist physicians in identifying high-risk patients earlier and more accurately, enabling closer monitoring and more timely interventions, ultimately improving the long-term prognosis for these patients.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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 Progress64%
Jan 2026Jun 2026

First Submitted

Initial submission to the registry

November 30, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 11, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 31, 2026

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

December 11, 2025

Status Verified

October 1, 2025

Enrollment Period

28 days

First QC Date

November 30, 2025

Last Update Submit

November 30, 2025

Conditions

Keywords

cardiac magnetic resonance; ST-segment elevation myocardial infarction; deep learning; prediction model

Outcome Measures

Primary Outcomes (1)

  • major adverse cardiac events

    major adverse cardiac events, such as cardiovascular death, recurrent myocardial infarction, hospitalization for heart failure, or unplanned repeat revascularization.

    2024-2026

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults over 18 with a first-time, primary PCI-treated STEMI, confirmed by biomarker and ECG criteria. Patients must be clinically stable (Killip class ≤ III) at presentation, have received guideline-adherent care, and provided informed consent for CMR and follow-up.

You may qualify if:

  • (1)diagnosis of STEMI , elevated cardiac biomarkers (troponin) above the 99th percentile upper reference limit together with at least one of the following: chest pain lasting \>30 minutes; ST-segment elevation ≥0.1 mV in two or more contiguous limb leads or ≥0.2 mV in two or more contiguous precordial leads on a 12-lead ECG; (2) age \>18 years, first episode of STEMI treated with primary PCI; (3)diagnostic and therapeutic management consistent with current clinical standards and guideline recommendations; (4) Killip class≤III at presentation; (5) provided informed consent for CMR imaging and clinical follow-up.

You may not qualify if:

  • (1) contraindications to CMR (e.g., cardiac pacemakers, severe claustrophobia, known allergy to gadolinium-based contrast agents, or impaired renal function defined as eGFR\<30mL/min/1.73m²). (2) structural heart disease (e.g., significant valvular or congenital disease); (3) documented history of prior myocardial infarction, PCI, or coronary artery bypass grafting (CABG); (4) comorbidities severely compromising overall prognosis or the ability to undergo the study procedures, such as serious hematological disorders, active systemic infections, or active malignancy; (5) cognitive impairment or psychiatric conditions precluding adequate cooperation with the CMR examination or clinical follow-up; (6) Poor-quality CMR images or missing essential sequences precluding accurate quantitative analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionMyocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 30, 2025

First Posted

December 11, 2025

Study Start

January 31, 2026

Primary Completion

February 28, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

December 11, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations