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This is an observational, prospective, multicenter study (12 hospitals belonging to the Italian Cardiology Network) in patients with STEMI ST elevation myocardial infarction (STEMI) treated successfully with primary percutaneous coronary intervention (PCI), that will be followed for 12 month after the acute event, in order to ascertain the predictive value of myocardial viability measured with cardiac magnetic resonance (1.5 T; based on the transmural distribution of late enhancement in the infarcted segments) for the identification of left ventricular (LV) remodelling (REM) 6 months after STEMI.
The present study is divided into 3 appointments following the standard inpatient stay for the index event (STEMI).
T0: Inpatient stay for index STEMI. Assessment of eligibility for participation in the study:
Visit 1 (V1): between 30 and 40 days post-STEMI. Clinical evaluation and performance of cardiac MRI with paramagnetic contrast agent (gadolinium) for measurement of infarct territory size and myocardial viability.
Visit 2 (V2): 6 months after STEMI. Clinical evaluation and second cardiac MRI, without contrast medium, for measurement of left ventricular volumes and consequently for measurement of the presence of adverse left ventricular remodeling.
Visit 3 (V3): 12 months after STEMI. Clinical re-evaluation with collection of data regarding events of interest for secondary endpoint. Performance of transthoracic echocardiogram.
The examinations and follow-up visits included in this study are part of clinical practice for treatment and risk assessment in patients who suffered STEMI with the exception of cardiac MRI without contrast medium at 6 months.
Cardiac magnetic resonance (CMR) data (1 month and 6 months) will be centrally analyzed post hoc at the MRI center.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac magnetic resonance | Diagnostic Test | Evaluate the predictive value of myocardial viability measured with cardiac magnetic resonance for the identification of LV REM 6 months after STEMI |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse left ventricular remodeling 6 month after index event | Adverse LV remodeling, defined as ≥12% increase in enddiastolic LV volume 6 months after STEMI Diagnostic accuracy of CMR performed 1 month after STEMI to predict actual LV remodeling at 6 months | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of cardiovascular adverse event 1 year after STEMI in patients with evidence of left ventricular remodeling at 6 months compared with those without remodeling | Incidence of the composite endpoint of death from cardiovascular causes, re-infarction, nonfatal stroke, new coronary revascularization interventions, development of heart failure, and new hospitalizations for cardiovascular causes 1 year after STEMI in patients with evidence of left ventricular remodeling at 6 months compared with those without remodeling. |
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Inclusion Criteria:
Exclusion Criteria:
Wearers of non-resonance-compatible devices; Previous surgery with placement of non-resonance-compatible vascular clips Claustrophobic patients; Patients with allergies and/or other specific contraindications to the use of paramagnetic contrast agents (gadolinium).
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Consecutive patients with acute ST-segment elevation myocardial infarction (STEMI) treated with effective primary angioplasty (PCI)
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Camici, MD, FACC | Ospedale San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS AOU San Martino | Genova | Italy | ||||
| IRCCS Centro Cardiologico Monzino |
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| ID | Term |
|---|---|
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Twelve months |
| Incidence of cardiovascular adverse events 1 year after STEMI in patients stratified with respect to total left ventricular viability | Incidence of cardiovascular adverse events 1 year after STEMI in patients stratified with respect to total left ventricular viability (i.e., percent left ventricular volume free of late enhancement (the total volume of the left ventricle showing no enhancement minus the volume of left ventricular myocardium with evidence of late enhancement). | Twelve months |
| Predictivity of the presence of microvascular obstruction | Predictivity of the presence of microvascular obstruction (MVO) in the infarcted area measured with CMR 1 month after STEMI on the development of LV remodeling at 6 months. | Six months |
| Predictivity of circulating biomarkers measured in the acute phase on the development of left ventricular remodeling six months after STEMI | Predictivity of circulating biomarkers [NT-proBNP, troponin T (TnT), PCR], measured in the acute phase on the development of left ventricular remodeling six months after STEMI. | Six months |
| Predictivity of circulating biomarkers measured in the acute phase on cardiovascular adverse events 12 months after STEMI | Predictivity of circulating biomarkers (NT-proBNP, TnT, PCR), measured in the acute phase on cardiovascular adverse events 12 months after STEMI. | Twelve months |
| Milan |
| Italy |
| IRCCS Fondazione Ca' Granda | Milan | Italy |
| IRCCS Istituto Auxologico Italiano | Milan | Italy |
| Paolo Camici | Milan | Italy |
| Irccs Sdn | Naples | Italy |
| IRCCS Policlinico San Matteo | Pavia | Italy |
| IRCCS Fondazione Policlinico Gemelli | Roma | Italy |
| IRCCS Policlinico San Donato | San Donato Milanese | Italy |
| IRCCS Multimedica | Sesto San Giovanni | Italy |