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Completed

NCT Number: NCT07057492

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients were required to meet the diagnostic criteria for STEMI, defined as elevated serum cardiac biomarkers (troponin) above the 99th percentile upper reference limit, accompanied by at least one of the following: 1.Chest pain lasting >30 minutes; 2.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 12-lead electrocardiography. Additional inclusion criteria: Age >18 years; First-time STEMI treated with primary PCI; Management strategy compliant with current clinical guidelines; Killip class ≤III; Willingness to undergo CMR examination and clinical follow-up.

Exclusion criteria

Patients were excluded if they had contraindications to CMR, including implanted cardiac pacemakers, claustrophobia, gadolinium contrast allergy, or renal insufficiency. Additional exclusions comprised those with Killip class IV heart failure or clinically unstable conditions, as well as concomitant valvular disease, congenital heart disease, pulmonary hypertension, or persistent atrial fibrillation-conditions known to confound cardiac structural/functional assessments. We also excluded individuals with prior myocardial infarction, PCI, or coronary artery bypass grafting (CABG) to ensure a first-event STEMI cohort. Finally, patients with psychiatric/neurocognitive disorders impairing compliance, or those with poor-quality or incomplete CMR sequences, were not enrolled.

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Treatment and study plan

Primary outcomes

  1. Major adverse cardiovascular events

    Time frame: From enrollment through the 3-year follow-up completion

  2. Major Adverse Cardiovascular Events

    Time frame: From enrollment to the 3-year follow-up completion

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • Beijing Anzhen Hospital
  • Beijing Chao Yang Hospital
  • First People's Hospital of Yulin
  • Second Affiliated Hospital of Nanchang University
  • Wuhan Asia Heart Hospital
  • Zunyi Medical College

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jul 9, 2025
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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