Coronary heart disease with stable angina or non-ST elevation myocardial infarction (NSTEMI) MedDRA version: 9.1 Level: LLT Classification code 10051592 Term: Acute coronary syndrome
Conditions
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Age > 18 y 2. Stable angina or inducible ischemia 3. Acute myocardial infarction without ST elevation (NSTEMI) 4. Planned angioplasty on one, two or three coronary lesions 5. Informed Consent Subgroup with coronary flow study Acute myocardial infarction without ST elevation (NSTEMI) Planned angioplasty on only one stenosis or on double lesion on single vessel 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: Exclusion Criteria 1. Atrial fibrillation (cases with coronary flow study) 2. ST elevation acute myocardial infarction (STEMI) 3. Contraindications to anti-platelet therapy or IIb/IIIa inhibitors 4. Hypertension (> 180/100 mmHg) 5. Planned angioplasty on more than three coronary stenoses 6. Two or more of the following procedural characteristics: stenoses in coronary bifurcations, multiple stenoses, stenoses in saphenous aorto-coronary grafts 7. Pregnancy or fertile age Subgroup with coronary flow study Atrial fibrillation Proximal tortuosity of the vessel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Aim of this study is to evaluate safety and efficacy of Iloprost in protecting coronary microcirculation during percutaneous angioplasty thanks to the action of Iloprost against vasoactive substances delivered during coronary dilatation. Iloprost efficacy will be detected by the capacity of the drug to reduce the incidence and severity of enzyme dismission after elective or urgent coronary angioplasty in patients without ST-elevation myocardial infarction (STEMI);Secondary Objective: the incidence and severity of enzyme dismission after elective or urgent coronary angioplasty in patients without ST-elevation myocardial infarction (STEMI);Primary end point(s): Peri-procedural myocardial infarction detected by an increase of T-Troponin (T-Troponin > 0,1 ng/mL (> Three times the normal upper limit of 0,03 ng/mL in the Laboratory of Azienda Ospedaliera S.Orsola Malpighi) | — |
Countries
Italy
Outcome results
None listed