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Myocardial Infarction (MI)CMR-RISK-STEMINCT07072858

Using Cardiac MRI to Predict Outcomes in Patients With STEMI

An observational study of Myocardial Infarction (MI) and ST Segment Elevation Myocardial Infarction (STEMI), run by Chinese PLA General Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Cardiac Magnetic Resonance Imaging (CMR)
Type of treatment
Injection or infusion
How many people
1,000 participants
Where
1 siteChina
Study dates
1 Jan 2014to 30 Dec 2025
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ying Zhang, PhD contact

15901369988

735147873@qq.com

China1 site, 1 recruiting
  • Study site

    Beijing

    Yundai Chen, PhD, 13688777232, cyundai@163.com

    Yundai Chen

    Recruiting

Other trials in China

About this study

Official title: Prognostic Value of Cardiac Magnetic Resonance Parameters in Patients With ST-Segment Elevation Myocardial Infarction

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.

Read more

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.

Read the detailed description

This is a prospective, multicenter observational study designed to investigate the prognostic value of comprehensive cardiac magnetic resonance (CMR) imaging parameters in patients with ST-segment elevation myocardial infarction (STEMI) who undergo primary percutaneous coronary intervention (PCI). The study focuses on leveraging artificial intelligence (AI)-based analysis to extract predictive features from a wide range of standard and advanced CMR sequences, aiming to identify imaging-derived biomarkers that provide independent and incremental value in forecasting long-term cardiovascular outcomes.

Traditional CMR indicators such as infarct size, left ventricular ejection fraction (LVEF), and microvascular obstruction (MVO) have demonstrated utility in post-MI risk stratification. However, these parameters do not fully exploit the wealth of information embedded within the full CMR dataset, especially data reflecting myocardial and atrial mechanics. In this study, we apply advanced computational methods-including radiomics, machine learning, and survival modeling techniques-to analyze multidimensional features extracted from routine, non-contrast CMR sequences.

CMR image acquisition includes short-axis cine imaging and dedicated functional sequences allowing for the quantification of bi-ventricular and bi-atrial function and deformation. Specifically, the following parameters are collected and analyzed:

  • Left Ventricular (LV) Parameters LV End-Diastolic Volume (LVEDV) LV End-Systolic Volume (LVESV) LV Stroke Volume (LVSV) LVEF Global Longitudinal Strain (LVGLS) Global Circumferential Strain (LVGCS) Global Radial Strain (LVGRS)
  • Right Ventricular (RV) Parameters RVEDV RVESV RVSV RV Mass RVEF RVGLS, RVGCS, RVGRS
  • Left Atrial (LA) Parameters Maximum Volume (LAVmax) Pre-Atrial Contraction Volume (LAVpac) Minimum Volume (LAVmini) Total, Passive, and Booster Emptying Fractions (LAEF) Reservoir, Conduit, and Booster Strain
  • Right Atrial (RA) Parameters RAVmax RAVpac RAVmini Total, Passive, and Booster RAEF RA Reservoir, Conduit, and Booster Strain All images are analyzed by trained imaging specialists using semi-automated tools (e.g., CVI42) for myocardial and atrial contouring. The left ventricular myocardium is segmented at the end-diastolic phase, and regions of interest (ROIs) are exported for radiomic analysis using ITK-SNAP and PyRadiomics. Preprocessing includes voxel size resampling, normalization, and gray-level discretization.

To ensure reliability and minimize redundancy, feature selection is performed in several stages. First, features with intra- and inter-observer intraclass correlation coefficients (ICC) ≥ 0.75 are retained. Second, highly collinear features are removed using correlation thresholding. Third, feature importance is assessed via random survival forests (RSF), followed by least absolute shrinkage and selection operator (LASSO) Cox regression to construct an optimized feature set. Selected features are used to calculate a radiomics-based risk score (RAD score), which is incorporated into survival models.

Patients are divided into a training and validation cohort using stratified random sampling based on MACE incidence. The primary outcome is the occurrence of major adverse cardiovascular events (MACE), including cardiovascular death, reinfarction, and heart failure hospitalization. Prognostic models are developed using multivariable Cox regression and evaluated using Harrell's concordance index (C-index), calibration plots, and time-dependent receiver operating characteristic (ROC) curves. Risk stratification analyses are conducted across subgroups defined by conventional imaging markers (e.g., infarct size, LVEF, MVO).

The analysis pipeline is implemented using R software, and internal validation is performed to assess model stability. Multiple imputation is used to address missing data, and sensitivity analyses are conducted to test the robustness of the predictive models under various assumptions. No experimental intervention or investigational drug is administered in this study; data collection is non-interventional and integrated into routine clinical care.

The anticipated contribution of this study is to establish a multimodal, AI-enhanced imaging framework that enables individualized post-STEMI risk assessment using routinely available CMR data. By going beyond visually assessed or conventional parameters, this study may uncover novel patterns of myocardial and atrial dysfunction predictive of long-term outcomes. Furthermore, the use of non-contrast imaging sequences enhances the generalizability and safety of the proposed risk evaluation method.

The protocol is approved by the institutional ethics committee. Quality control includes standardized image acquisition and analysis procedures across centers. Data processing follows pre-specified standard operating procedures (SOPs) for image segmentation, radiomic feature extraction, and modeling. Manual and automated data checks are implemented to ensure consistency and accuracy. The imaging core lab and analytic team remain blinded to outcome data during feature extraction and model construction phases.

By combining cutting-edge image analysis with real-world clinical data, this study aims to inform future CMR-based guidelines for post-infarction care and to facilitate clinical translation of advanced imaging biomarkers into personalized cardiology.

Being tested
Cardiac Magnetic Resonance Imaging (CMR)
Keywords
ST Segment Elevation Myocardial Infarction, Cardiac Magnetic Resonance Imaging, Cardiac Strain Imaging, Machine Learning, Image Analysis, Survival Analysis, Multimodal Imaging
Medical subject headings
Myocardial Infarction, ST Elevation Myocardial Infarction, Ventricular Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT07072858
Study groupRoleWhat they receive
STEMI Patients Undergoing CMR After PCINot described
Receives: Diagnostic Test: Cardiac Magnetic Resonance Imaging (CMR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2025
  2. Study start1 Jan 2014
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07072858
Sponsor's protocol ID
S2025-061-01
Acronym
CMR-RISK-STEMI
Status last verified
Jan 2025
First submitted
9 Jul 2025
Last updated
18 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Infarction (MI) and ST Segment Elevation Myocardial Infarction (STEMI), run by Chinese PLA General Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact XIN A, PhD (+8613126526196, a2013346@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Major Adverse Cardiovascular Events (MACE) (time frame: From the date of CMR imaging to the first occurrence of MACE during follow-up (maximum of 5 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.

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