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

NCT07057492 | Completed

• 1 other identifier: 2018QG-CMR
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ST-segment Elevation Myocardial Infarction (STEMI)

Keywords

ST-segment elevation Myocardial Infarction；cardiac magnetic resonance; prediction model

Outcome Measures

Primary Outcomes (2)

• Major adverse cardiovascular events

  From enrollment through the 3-year follow-up completion

• Major Adverse Cardiovascular Events

  From enrollment to the 3-year follow-up completion

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

primary PCI-treated patients with acute STEMI

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Beijing Anzhen Hospital: collaborator
• Beijing Chao Yang Hospital: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• First People's Hospital of Yulin: collaborator
• Wuhan Asia Heart Hospital: collaborator
• Zunyi Medical College: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chinese PLA General Hospital

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 9, 2025
• Study Start: January 1, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 9, 2025

Record last verified: 2018-01

Locations

CN (1)