PRevEntion of cardiac and Vascular pEriprocedural complications in patients undergoiNg coronary angiography or angioplasTy: IntraCoronary Adenosine administration to prevent peRiprocedUral myonecrosiS in elective coronary angioplasty. A prospective double-blind randomized trial (PREVENT ICARUS) trial - PREVENT-ICARUS
- Conditions
- Elective coronary angioplastyMedDRA version: 9.1Level: SOCClassification code 10047065
- Registration Number
- EUCTR2009-013681-92-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA MAGGIORE DELLA CARITA` DI NOVARA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Patients undergoing elective coronary angioplasty
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
Marked Bradicardia (< 40 bpm).
Previous allergy to adenosin.
Inability to sign the informed consent.
Asthma
Elevated cardiac enzymes (troponin I o CK-MB)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the benefits from adjunctive intracoronary administration of adenosin in elective patients undergoing coronary angioplasty.;Secondary Objective: N.D.;Primary end point(s): Periprocedural troponin I release > 3 times the normal upper limit
- Secondary Outcome Measures
Name Time Method