ReModeling in ST-elevation myocARrdial Infarction: a Comparison of Left VEntricuLar Functions in Long-term Follow-up Among STEMI Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: STEMI. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
ReModeling in ST-elevation myocARrdial Infarction: a Comparison of Left VEntricuLar Functions in Long-term Follow-up Among STEMI Patients: The MARVEL Study
Overview
Patients diagnosed with STEMI who underwent pPCI were included in this study. The investigators collected comprehensive data on each patient's status, including laboratory findings such as NT-proBNP, troponin levels, and inflammatory profile assessed by leukocyte count, C-reactive protein, interleukin-1, and interleukin-6. Additionally, electrocardiographic and echocardiographic features, details of the coronary intervention procedure, hospital stay duration, complications, and medical treatments were recorded. Comprehensive transthoracic echocardiograms (TTE) were performed at admission and before discharge. Myocardial tissue characterization was conducted by cardiac magnetic resonance (CMR) imaging before discharge, assessing intramyocardial hemorrhage (IMH), microvascular obstruction (MVO), infarct size (IS), area at risk (AAR), salvaged myocardium, and salvage index. At the six-month follow-up, laboratory tests, CMR imaging, and TTE were repeated, along with a thorough clinical evaluation. LVR was defined by one of the following criteria: a 20% increase in end-diastolic volume by TTE or 12% by CMR, a 15% increase in end-systolic volume, a sphericity index greater than 42% (CMR only), the emergence of new concentric hypertrophy, or a reduction greater than 10% in left ventricular ejection fraction (LVEF).
Detailed description
Patients diagnosed with STEMI who underwent pPCI were included in this study. The investigators collected comprehensive data on each patient's status, including laboratory findings such as NT-proBNP, troponin levels, and inflammatory profile assessed by leukocyte count, C-reactive protein, interleukin-1, and interleukin-6. Additionally, electrocardiographic and echocardiographic features, details of the coronary intervention procedure, hospital stay duration, complications, and medical treatments were recorded.
Comprehensive transthoracic echocardiograms (TTE) were performed at admission and before discharge. Myocardial tissue characterization was conducted by cardiac magnetic resonance (CMR) imaging before discharge, assessing intramyocardial hemorrhage (IMH), microvascular obstruction (MVO), infarct size (IS), area at risk (AAR), salvaged myocardium, and salvage index.
At the six-month follow-up, laboratory tests, CMR imaging, and TTE were repeated, along with a thorough clinical evaluation. LVR was defined by one of the following criteria: a 20% increase in end-diastolic volume by TTE or 12% by CMR, a 15% increase in end-systolic volume, a sphericity index greater than 42% (CMR only), the emergence of new concentric hypertrophy, or a reduction greater than 10% in left ventricular ejection fraction (LVEF).
Primary outcome measures
- Remodeling [Time frame: 36 months]
Eligibility criteria
Inclusion criteria
- STEMI
Exclusion criteria
- Contraindication to CMR imaging
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- University of Pisa, Cisanello Hospital — Pisa
Identifiers
NCT: NCT07041840 · MARVEL