The purpose of this study is to assess whether the Index of Microcirculatory Resistance (IMR) can be considered a prognostic predictor for the occurrence of events at one year of follow up after primary Percutaneous Coronary Intervention (PCI) in ST-Elevation Myocardial Infarction (STEMI) patients. Any correlation between IMR and the short and medium term outcomes, defined as cardiovascular death, re-Myocardial Infarct (MI), re-hospitalization for Heart Failure (HF), resuscitation or Implantable Cardioverter Defibrillator (ICD) appropriate shock, will be assessed in the study.
Prospective, multicentre study designed to evaluate IMR ability to predict events occurrence, defined as Cardiovascular death, re-MI, re-hospitalization for HF, resuscitation or ICD appropriate shock, during a 1 year follow-up period. All participants will have the culprit lesion treated following clinical practice and guidelines; Fractional Flow Reserve (FFR) and IMR will be measured after the primary PCI procedure to evaluate treatment success and myocardial viability. Non-culprit lesions will be functionally evaluated through FFR index and will be treated if FFR will show functional stenosis. FFR and IMR will be measured to evaluate treatment success and myocardial viability. Patients will be followed-up at 1m, 6m and 1y periods.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
242
Assessment of IMR index in coronaries through PressureWire Certus guidewire
Ospedale Giovanni Paolo II
Sciacca, Agrigento, Italy
Ospedale Generale Regionale "F. Miulli"
Acquaviva delle Fonti, BA, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, FI, Italy
Azienda Ospedaliera Villa Scassi
Genova, GE, Italy
Fondazione Toscana G.Monasterio - Ospedale del Cuore
Massa, MS, Italy
Azienda Ospedaliera di Padova
Padova, PD, Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Pesaro, PU, Italy
Fondazione IRCCS Policlinico S.Matteo
Pavia, PV, Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, RE, Italy
Ospedale di Castelfranco Veneto
Castelfranco Veneto, Treviso, Italy
...and 4 more locations
Composite of: Cardiovascular Death*, Re-myocardial Infarct, Re-hospitalization for Heart Failure (HF) and Congestive Heart Failure (CHF), Resuscitation or ICD Appropriate Shock.
Composite of: cardiovascular death\*, re-myocardial infarct, re-hospitalization for heart failure (HF) and Congestive Heart Failure (CHF), resuscitation or ICD appropriate shocK, at 1 year. \* = timing of mortality evaluation: once culprit lesion has been evaluated through IMR Composite endpoint was evaluated as time to first event, whichever individual component occurred first.
Time frame: 1 year
New Congestive Heart Failure (CHF) During Index Hospitalization
Count of participants with a new CHF during index hospitalization. Hospital stay expected average = 5-10 days
Time frame: At the end of hospital stay
Left Ventricular (LV) Remodeling
Left Ventricular (LV) remodeling at 1 year; improvement of Ejection Fraction %(EF) assessed by TTE. A TTE evaluation has been done both at discharge and at 1-year fup.
Time frame: 1 year
Left Ventricular (LV) Remodeling
Left Ventricular (LV) remodeling at 1 year; improvement of Left Ventricular End Systole Volume (LVESV) and Left Ventricular End Diastole Volume (LVEDV) assessed by TTE. A TTE evaluation has been done both at discharge and at 1-year fup.
Time frame: 1 year
Left Ventricular (LV) Remodeling
Left Ventricular (LV) remodeling at 1 year; improvement of Left Ventricular End Diastole Diameter (LVEDD) and Left Ventricular End Systole Diameter (LVESD) assessed by TTE. A TTE evaluation has been done both at discharge and at 1-year fup.
Time frame: 1 year
Left Ventricular (LV) Remodeling
Left Ventricular (LV) remodeling at 1 year; improvement of 16 segments Wall Motion Score Index (WMSI) assessed by TTE. A TTE evaluation has been done both at discharge and at 1-year fup. 16WMSI = 1 is considered normokinetic; 16WMSI = 1,5 is considered mild hypokinesia; 16WMSI = 2 is considered hypokinesia; 16WMSI = 2,5 is considered severe hypokinesia; 16WMSI = 3 is considered akinetic. Scale range: from 1 to 3
Time frame: 1 year
Left Ventricular (LV) Remodeling - Mitral Insufficiency
Left Ventricular (LV) remodeling at 1 year; improvement of mitral insufficiency (MI) values assessed by TTE. A TTE evalutation has been done both at discharge and at 1-year fup. Each row reports the number of participants that have that specific grade of mitral insufficiency. Grade = 0 indicates no MI; grade = 1 indicates mild MI; grade = 2 indicates moderate MI; grade = 3 indicates severe MI
Time frame: 1 year
Need for New Revascularization
Incidence of new revascularizations at 1 year
Time frame: 1 year
Stent Thrombosis
Incidence of stent thrombosis at 1 year
Time frame: 1 year
Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events
Evaluation of a better cut-off of IMR index based on primary endpoints events. Table below reports the values of ROC curve.
Time frame: 1 year
Evaluation of Possible Events Predictors
Results of logistic regression model; differences were considered statistically significant when p\<0,05.
Time frame: 1 year
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