Cardiac magnetic resonance
Diagnostic TestEvaluate the predictive value of myocardial viability measured with cardiac magnetic resonance for the identification of LV REM 6 months after STEMI
NCT Number: NCT04699565
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.
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Notify Me18 year–80 year
All sexes
Observational
IRCCS AOU San Martino, Genova, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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).
Evaluate the predictive value of myocardial viability measured with cardiac magnetic resonance for the identification of LV REM 6 months after STEMI
Time frame: Six months
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
Time frame: Twelve months
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.
Time frame: Twelve months
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).
Time frame: Six months
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.
Time frame: Six months
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.
Time frame: Twelve months
Predictivity of circulating biomarkers (NT-proBNP, TnT, PCR), measured in the acute phase on cardiovascular adverse events 12 months after STEMI.
IRCCS San Raffaele
Other
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