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Comparison between Dipyridamole and Adenosine infusion in the evaluation of intermediate coronary restrictions (stenoses) in the cardiac catheterization laboratorY.

Phase 1
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
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).

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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