EUCTR2014-004486-25-IT
Active, not recruiting
Phase 1
Prevention of the reperfusion myocardical damage in patients with acute myocardial infarct submitted to primary PCI through infusion of 'glutatione sale sodico' ev.
niversity Hospital Policlinico Umberto I0 sites90 target enrollmentDecember 4, 2014
DrugsTAD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- acute myocardial infarct
- Sponsor
- niversity Hospital Policlinico Umberto I
- Enrollment
- 90
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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