Using Cardiac MRI to Predict Outcomes in Patients With STEMI

NCT07072858 | Recruiting DMC

• 1 other identifier: S2025-061-01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, multicenter observational study aims to evaluate the prognostic value of a comprehensive set of cardiac magnetic resonance (CMR) imaging parameters in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). The study integrates advanced artificial intelligence (AI) techniques to extract and analyze high-dimensional imaging features from multiple CMR sequences-including cine, strain mapping, and functional sequences-going beyond traditional measures such as infarct size or microvascular obstruction. The primary objective is to identify novel prognostic markers from routinely acquired CMR images that reflect myocardial structure, function, and mechanical deformation (strain), and to assess their association with long-term clinical outcomes. In addition to standard parameters, the study includes a detailed evaluation of left and right ventricular systolic and diastolic volumes, ejection fractions, and biventricular strain components (including longitudinal, circumferential, and radial strain), as well as left and right atrial volumes, emptying fractions, and reservoir/conduit/booster strain indices. Approximately 1000 STEMI patients will undergo CMR scanning within one week after PCI. The imaging data will be subjected to AI-based feature extraction and dimensionality reduction algorithms to uncover latent patterns associated with adverse outcomes. Patients will be followed for up to three years for the occurrence of major adverse cardiovascular events (MACE), including cardiovascular death, recurrent myocardial infarction, and heart failure hospitalization. The central hypothesis is that comprehensive CMR functional and strain-derived parameters, when analyzed using AI-driven models, offer independent and incremental prognostic value beyond conventional clinical risk factors. This study seeks to establish a data-driven, multimodal imaging framework for personalized risk stratification in STEMI patients, potentially enabling more precise post-infarction management strategies. No investigational treatment is involved. All imaging and clinical data are collected as part of routine care and analyzed retrospectively for outcome prediction.

Conditions

Myocardial Infarction (MI); ST Segment Elevation Myocardial Infarction (STEMI); Magnetic Resonance Imaging (MRI); Heart Ventricles; Artificial Intelligence (AI); Prognosis; Ventricular Dysfunction

Keywords

ST Segment Elevation Myocardial Infarction; Cardiac Magnetic Resonance Imaging; Cardiac Strain Imaging; Machine Learning; Image Analysis; Survival Analysis; Multimodal Imaging

Outcome Measures

Primary Outcomes (1)

• Occurrence of Major Adverse Cardiovascular Events (MACE)

  Major Adverse Cardiovascular Events (MACE) is defined as a composite outcome including cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure. The occurrence of MACE during follow-up will be used to assess the prognostic value of CMR-derived parameters and AI-based imaging features.

  From the date of CMR imaging to the first occurrence of MACE during follow-up (maximum of 5 years)

Study Arms (1)

STEMI Patients Undergoing CMR After PCI

Diagnostic Test: Cardiac Magnetic Resonance Imaging (CMR)

Interventions

Cardiac Magnetic Resonance Imaging (CMR) DIAGNOSTIC_TEST

Cine CMR imaging was performed with steady-state free precession covering short axis continuously from the mitral annulus to the apical level in the 2-, 3- and 4- chamber views using the following parameters: repetition time (TR) = 3.73 ms, echo time (TE) = 1.87 ms, flip angle = 60°, slice thickness 8.0 mm. Cine images of all included patients were acquired prior to contrast administrations. Late gadolinium enhancement images (LGE) images were obtained 10-15 minutes after intravenous injection of gadolinium (0.1 mmol/kg at 3ml/s) at end-diastolic phase on the short axis (TR=6.09 ms; TE= 3.0 ms; flip angle 60°; thickness 8.0 mm) with breath-hold phase-sensitive segmented inversion recovery (PSIR) fast field echo sequence. T2-weighted sequence was performed using turbo spin-echo (TSE)-sequence (TR=1714-2000 ms; TE=8.04 ms; slice thickness 8.0 mm) to estimate myocardial edema. Images were analyzed on freely available validated cardiovascular image analysis software CVI42 (Circle Cardiovas

STEMI Patients Undergoing CMR After PCI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients diagnosed with ST-segment elevation myocardial infarction (STEMI) who are treated with primary percutaneous coronary intervention (PCI). Eligible participants must be able to undergo cardiac magnetic resonance (CMR) imaging within one week of PCI. Patients are recruited from cardiology departments at high-volume centers with established CMR capabilities. The population includes both men and women, aged 18 to 80 years, representing a typical real-world cohort of STEMI patients in clinical practice. Patients with significant comorbidities, contraindications to MRI, or recent prior revascularization are excluded to ensure reliable image interpretation and outcome attribution.

You may qualify if:

• Age between 18 and 80 years
• Diagnosed with ST-segment elevation myocardial infarction (STEMI), defined as chest pain with ST-segment elevation on ECG and elevated cardiac troponin levels
• Underwent primary percutaneous coronary intervention (PCI)
• Able to undergo cardiac magnetic resonance (CMR) imaging within 7 days post-PCI
• Provided written informed consent

You may not qualify if:

• Contraindications to CMR (e.g., severe claustrophobia, implanted cardiac defibrillators or non-compatible pacemakers)
• History of revascularization therapy (PCI or CABG) within the previous 6 months
• Severe valvular heart disease or known cardiomyopathy
• Presence of bundle branch block or fascicular block that interferes with image interpretation
• Known allergy to gadolinium-based contrast agents (for those undergoing contrast-enhanced sequences)
• Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m² (if contrast use is anticipated)
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Unknown Facility

Beijing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Myocardial Infarction; ST Elevation Myocardial Infarction; Ventricular Dysfunction

Condition Hierarchy (Ancestors)

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

Central Study Contacts

XIN A, PhD

CONTACT

+8613126526196; a2013346@hotmail.com

Ying Zhang, PhD

CONTACT

15901369988; 735147873@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: January 1, 2014
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-01

Locations

CN (1)