Tissue Characterization in STEMI Using Cardiac MRI: a Multicenter Registry

December 5, 2025 updated by: Fundación para la Investigación del Hospital Clínico de Valencia

Tissue Characterization in ST-Segment Elevation Myocardial Infarction: A Multicenter Registry of Patients Evaluated With Cardiac Magnetic Resonance

This multicenter registry includes patients with a first ST-segment elevation myocardial infarction (STEMI) who underwent cardiac magnetic resonance (CMR) imaging during the acute phase and follow-up. The registry is designed to identify clinical and CMR-derived predictors of adverse ventricular remodeling and major adverse cardiac events (MACE). CMR provides accurate and reproducible assessment of infarct size, left ventricular function, microvascular obstruction, and tissue characteristics, enabling detailed prognostic modeling.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Adverse left ventricular remodeling after STEMI is a key determinant of long-term morbidity and mortality. Although primary PCI and guideline-directed therapies have improved outcomes, 10-15% of patients still develop adverse remodeling and heart failure. CMR enables precise measurement of infarct size, left ventricular volumes, ejection fraction, microvascular obstruction, and tissue parameters (T1, extracellular volume), which may enhance risk stratification compared with other imaging techniques.

The registry is based on harmonized clinical and imaging datasets from three experienced centers in Spain, forming a large repository of standardized variables. This structure facilitates the identification of predictors of infarct size, ventricular remodeling, and major adverse cardiac events (MACE), and provides a framework for the development of improved prognostic models and the exploration of potential therapeutic targets.

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron de Barcelona
      • Valencia, Spain, 46010
        • Hospital Clinico de Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of patients admitted with a first ST-segment elevation myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention (PCI) and were evaluated by cardiac magnetic resonance (CMR) both in the acute phase and during follow-up. The study is conducted in tertiary academic hospitals with well-established CMR programs, ensuring standardized imaging protocols and high-quality data acquisition. Participating centers include the Hospital Clínic de Barcelona, the Hospital Clínico Universitario de Valencia, and the Hospital Universitari Vall d'Hebron, all located in Spain.

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • First STEMI evaluated within the first 24 hours of symptom onset
  • At least one CMR performed during the acute phase
  • Signed informed consent (for prospective patients) or previous consent (for retrospective inclusion).

Exclusion Criteria:

  • Severe renal failure (GFR < 30 ml/min)
  • STEMI > 24 hours after symptom onset
  • Contraindications to CMR (e.g., claustrophobia, hemodynamic instability, non-MR-compatible devices, vascular clips)
  • Pregnancy or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients
Patients admitted with a first STEMI treated with primary PCI, evaluated by CMR in the acute phase and follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of MACE (Major Adverse Cardiac Events)
Time Frame: From hospital discharge (or index CMR) to at least 6 months, with extended follow-up planned for as long as 5 years, subject to data availability.

The primary endpoint is the occurrence of MACE during follow-up. MACE is defined as a composite of the following events:

Cardiac death (death attributable to cardiovascular causes) Heart failure hospitalization (unplanned admission with a primary diagnosis of heart failure) Heart transplantation or durable mechanical circulatory support Appropriate ICD therapy (appropriate shock or anti-tachycardia pacing for ventricular arrhythmia in patients with implantable defibrillators).

The occurrence of the first event in the composite will be used for time-to-event analyses.

The first event in the composite will be used for time-to-event analyses. Event classification will be determined according to standardized definitions and based on review of available medical records.
From hospital discharge (or index CMR) to at least 6 months, with extended follow-up planned for as long as 5 years, subject to data availability.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Collaborators

Hospital Clinic of Barcelona
Hospital Vall d'Hebron

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

September 30, 2025

Study Completion (Estimated)

December 31, 2036

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

December 5, 2025

First Posted (Actual)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STEMI-RMC Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified individual participant data (IPD) will not be shared because data sharing is not planned for this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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