Prevention of the reperfusion myocardical damage in patients with acute myocardial infarct submitted to primary PCI through infusion of 'glutatione sale sodico' ev.

Phase 1

• Conditions: acute myocardial infarct; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-004486-25-IT
• Lead Sponsor: niversity Hospital Policlinico Umberto I

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-04
• Last Update Posted: 19 March 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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