PROMISE AMI (PROtection of coronary Microcirculation by Iloprost: Safety and Efficacy evaluation in Acute Myocardial Infarction treated by primary PCI) Pilot Study - Promise AMI

Conditions: Acute myocardial infarction
MedDRA version: 9.1Level: LLTClassification code 10064346Term: STEMI

Registration Number: EUCTR2008-001325-34-IT

Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures