A Prospective Multicenter Clinical Study on the Long-term Prognosis of Patients With ST-segment Elevation Myocardial Infarction Using Cardiac Magnetic Resonance Imaging.

NCT ID: NCT07057492

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2024-12-31

Brief Summary

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This prospective, multicenter study was designed to develop and validate a risk prediction model for major adverse cardiovascular events (MACE) in patients with acute ST-segment elevation myocardial infarction (STEMI) based on cardiac magnetic resonance (CMR) parameters.

From January 2018 to December 2023, consecutive acute STEMI patients who underwent primary percutaneous coronary intervention (PCI) were enrolled across eight participating medical centers. Baseline clinical characteristics were systematically collected, and all patients underwent CMR examination 5-7 days after PCI to assess myocardial injury and functional parameters. The primary composite endpoint, MACE, included cardiovascular death, recurrent myocardial infarction, hospitalization for heart failure, and unplanned revascularization.

To ensure robust model development and validation, the study assigned patients from four centers to form the development cohort, while those from the other four centers constituted the external validation cohort. Predictive variables were initially screened using least absolute shrinkage and selection operator (LASSO) regression, followed by multivariable Cox proportional hazards regression to identify independent predictors. A nomogram was subsequently constructed to provide individualized risk stratification. Model performance was evaluated in terms of discrimination (C-index, ROC analysis), calibration (calibration curves), and clinical utility (decision curve analysis).

This study aims to develop a CMR-based prediction model to better identify high-risk STEMI patients, providing clinicians with valuable tools for early intervention and personalized management.

Detailed Description

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Conditions

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ST-segment Elevation Myocardial Infarction (STEMI)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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the development cohort

The development cohort consisted of STEMI patients from four major medical centers, all of whom received primary PCI treatment and underwent cardiac magnetic resonance imaging. This cohort served as the basis for constructing the prognostic prediction model.

No interventions assigned to this group

the external validation cohort

The external validation cohort comprised STEMI patients from four additional medical centers, all of whom underwent primary PCI and subsequent cardiac magnetic resonance imaging. This independent cohort was used to evaluate the model's generalizability and predictive performance in diverse clinical settings.

No interventions assigned to this group

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Anzhen Hospital

OTHER

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role collaborator

First People's Hospital of Yulin

OTHER

Sponsor Role collaborator

Wuhan Asia Heart Hospital

OTHER

Sponsor Role collaborator

Zunyi Medical College

OTHER

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qian geng

Chinese PLA General Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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2018QG-CMR

Identifier Type: -

Identifier Source: org_study_id

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