Acute myocardial infarction MedDRA version: 9.1 Level: LLT Classification code 10064346 Term: STEMI
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age > 18 y 2. Acute myocardial infarction (STEMI) with ST segment elevation in at least two contiguous leads and thoracic pain lasting over 20 minutes and less than 6 hours 3. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Acute myocardial infarction without ST elevation (NSTEMI) 2. Complete left bundle branch block 3. Previous STEMI in the same territory 4. Contraindications to anti-platelet therapy or IIb/IIIa inhibitors 5. Hypertension (> 180/100 mmHg) 6. Pregnancy or fertile age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This pilot phase has the purpose to evaluate the effectiveness of Iloprost in terms of increase of the percentage of patients with complete ST resolution (primary endpoint).;Secondary Objective: The improvement of the result of coronary angioplasty will be measured by the reduction of ST segment elevation, expression of transmural ischemia characterizing acute myocardial infarction. In respect to the control group, to be considered effective Iloprost should increase the number of patients with ?complete resolution? of ST segment elevation 90 minutes after stent implantation.;Primary end point(s): ST resolution 90 min after the vessel recanalization | — |
Countries
Italy