Comparison between Dipyridamole and Adenosine infusion in the evaluation of intermediate coronary restrictions (stenoses) in the cardiac catheterization laboratorY.
- Conditions
- Patients with a single = 50% e <75% coronary stenosis (visually extimated) at angiography, in one ore more coronary vessels).Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2010-024485-21-IT
- Lead Sponsor
- FONDAZIONE TOSCANA GABRIELE MONASTERIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 75
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
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method