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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-001325-34-IT
Enrollment
Unknown
Registered
2008-06-20
Start date
2008-04-01
Completion date
Unknown
Last updated
2014-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myocardial infarction MedDRA version: 9.1 Level: LLT Classification code 10064346 Term: STEMI

Interventions

Sponsors

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

Eligibility

Sex/Gender
All

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

MeasureTime 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

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026