acute myocardial infarct
Conditions
Interventions
Trade Name: TAD
Pharmaceutical Form: Powder and solvent for solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Sponsors
University Hospital Policlinico Umberto I
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ACS in patients submitted to p-PCI up to 12 hours Age=18 years Women and Men Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: Patients with cardiac arrest, ventricular fibrillation, cardiogenic shock, stent thrombosis, previous acute myocardial infarction, or angina within 48 hours before infarction were not included in the study. Patients with evidence of coronary collaterals (2-3 Rentrop) to the region at risk on initial coronary angiography (at the time of admission) will be excluded. Patients with EF = 30% The patient has impaired renal function (creatinine > 3.0 mg/dl); The patient has known allergies to aspirin, clopidogrel bisulfate and ticlopidine, heparin, contrast media or stainless steel that cannot be managed medically; The patient needs therapy with warfarin; The patient has a life expectancy less than 12 months; Recipient of heart transplant; The patient is currently participating in an investigational drug or another device study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To verify if the intravenous infusion of “glutatione sale sodico” it is able to reduce the level of oxidative state in the area of myocardial infarction.;Secondary Objective: To verify if the intravenous infusion of “glutatione sale sodico” during the procedures of primary PCI it is able to limit the extension of the ischemic area, to reduce the incidence of the no-reflow, to improve the degree of myocardial blush and to decrease the indexes of suffering post-procedural ischemia (ST elevation; release of myocardial necrosi markers).;Primary end point(s): The primary endopoint will consist in the assessment of the effects of the infusion of “glutatione sale sodico” on the reduction of the oxidative markers and inflammation after PCI ;Timepoint(s) of evaluation of this end point: Up to 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endopoint will include: 1) the assessment of the variations of the corrected TIMI frame count (cTFC) and the TIMI Myocardial Perfusion Grade (TMPG) after PCI; 2) the assessment of the middle values of peak of the cardiac Troponin, after the procedure; 3) To verify,through telephone contact or a programmed visit, the principal adverse clinical events as death, acute myocardial infarct, stent's thrombosis of the treated vessels or the occurence of a new revascularization, up to 6 months after the procedure. Medical Doctors don't have the knowledge both about the possible infusion of the glutatione ev, in the examined patient, than others clinical data. Moreover, sierological levels of Troponin and creatinine will be measured before the PCI and after the procedure (2, 6, 12 and 24 hours). Besides, through 2D Echocardiography with Simpson's biplane method the FE will be calculate at admission and after hospital discarge. In the case in which clinical-instrumental signs of ischemia will rise up patient will be submit to a new angrography. ;Timepoint(s) of evaluation of this end point: Up to 6 months | — |
Countries
Italy
Contacts
Public ContactEnrico Mangieri
University Hospital Policlinico Umberto I
Outcome results
None listed