ReModeling in ST-elevation myocARrdial Infarction: a Comparison of Left VEntricuLar Functions in Long-term Follow-up Among STEMI Patients

NCT ID: NCT07041840

Last Updated: 2025-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2027-01-01

Brief Summary

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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

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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).

Conditions

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STEMI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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STEMI

STEMI

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* STEMI

Exclusion Criteria

* Contraindication to CMR imaging
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pisa

OTHER

Sponsor Role lead

Responsible Party

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Mattia Alberti

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Pisa, Cisanello Hospital

Pisa, Pisa, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Mattia Alberti, Dr

Role: CONTACT

+393271946335

Facility Contacts

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Mattia Alberti, Dr

Role: primary

+39050995317

Other Identifiers

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MARVEL

Identifier Type: -

Identifier Source: org_study_id

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