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NCT Number: NCT07291999

Tissue Characterization in STEMI Using Cardiac MRI: a Multicenter Registry

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.

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This study is active but is not currently recruiting participants.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínic de Barcelona, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Other

Collaborators

  • Hospital Clinic of Barcelona
  • Hospital Vall d'Hebron

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2036
First posted
Dec 18, 2025
Registry last updated
Dec 18, 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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