Ischemic Cardiovascular DiseaseNCT07291999
Tissue Characterization in STEMI Using Cardiac MRI: a Multicenter Registry
An observational study of Ischemic Cardiovascular Disease and Magnetic Resonance, run by Fundación para la Investigación del Hospital Clínico de Valencia at 3 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Cardiovascular Disease, Magnetic Resonance
- How many people
- 500 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Jan 2025to 31 Dec 2036
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Vall d'Hebron de Barcelona
Barcelona, 08035
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital Clínico de Valencia
Valencia, 46010
About this study
Official title: 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.
Read the 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.
- Keywords
- STEMI, Cardiac magnetic resonance
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients admitted with a first STEMI treated with primary PCI, evaluated by CMR in the acute phase and follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of MACE (Major Adverse Cardiac Events)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Jan 2025
- Primary completion30 Sep 2025
- Study completion31 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Hospital Vall d'Hebron
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291999
- Sponsor's protocol ID
- STEMI-RMC Registry
- Status last verified
- Oct 2025
- First submitted
- 25 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data (IPD) will not be shared because data sharing is not planned for this study.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Characterization in ST-Segment Elevation Myocardial Infarction: A Multicenter Registry of Patients Evaluated With Cardiac Magnetic Resonance
- ClinicalTrials.gov ID
- NCT07291999
- Acronym / sponsor ID
- STEMI-RMC Registry
- Keywords
- STEMI, Cardiac magnetic resonance
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Hospital Vall d'Hebron
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 31 Dec 2036 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients admitted with a first STEMI treated with primary PCI, evaluated by CMR in the acute phase and follow-up |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No. De-identified individual participant data (IPD) will not be shared because data sharing is not planned for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Cardiovascular Disease and Magnetic Resonance, run by Fundación para la Investigación del Hospital Clínico de Valencia at 3 sites in Spain.
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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 Dec 2025.