EUCTR2010-024485-21-ITActive, not recruitingPhase 1
Dipyridamole versus Adenosine infusion in the physiologic assessment of Intermediate coronary Stenoses in the cardiac catheterization laboratorY - DAISY
FONDAZIONE TOSCANA GABRIELE MONASTERIO0 sites75 target enrollmentStarted: January 15, 2013Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 75
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Patients of any race, male or female gender, with a single = 50% e <75% coronary stenosis (visually extimated) at angiography, in one ore more coronary vessels. Age = 18 years. Patients should sign an informed consent prior to the enrollment in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
Exclusion Criteria
- •Known intolerance of adenosine and/or dypiridamol and/or teophylline or of the eccipients. Patients who have taken caffein or food or beverages containig caffein and/or similar substances 24 hours before the procedure. Left main or aorto-ostial lesions. Lesions in severely tortuous or calcific vessels. Severely impaired left ventricular function (EF<35%). Chronic obstructive bronchopneumopathy or bronchial asthma Atrio-ventricular block >I°. Stenosis >70% of supra-aortic vessels. Concomitant treatment with teophylline-derivatives. Concomitant therapy with phosphodiesterase inhibitors derivatives. Hypotension (PASys <100 mmHg). Atrial fibrillation. Pregnant or lactating women. Pazients with a lesion in a culprit coronary vessel in patients with prior or recent myocardial infarction. Pazients with ST-elevation myocardial infarction =5 days (lesion in non-culprit vessel).
Investigators
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