Application of Sildenafil in patients with documented coronary vasospasm in order to explore the pathophysiology of coronary vasospasm and the therapeutic effects of Sildenafil in patients suffering from coronary spasm
- Conditions
- Coronary vasospasm is an abrupt severe vasoconstriction of coronary arteries leading to myocardial ischemia and angina pectoris. The reason for the occurrence of coronary spasm and the cellular mechanism causing coronary spasm is still not elucidated. Thus, an appropriate medical therapy has not been established so far. In patients suffering from coronary vasospasm the possible anti-spastic effect of sildenafil is to be analysed with this study.
- Registration Number
- EUCTR2006-003116-22-DE
- Lead Sponsor
- Prof. Sechtem, Department of Cardiology, Robert Bosch Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 0
Inclusion Criteria
- agreement with this study
- documentation of coronary vasospasm in a diagnostic intracoronary acetylcholine-testing
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
- contraindication against Sildenafil
- presence of coronary artery disease
- cardiomyopathy
- hepatic diseases
- age < 50y
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Has Sildenafil the potency to inhibit the induction of coronary vasospasm?;Secondary Objective: Which degree of spasm inhibition can be achieved with Sildenafil?;Primary end point(s): Inhibition of coronary spasm induction with the use of intracoronary acetylcholine after taking Sildenafil
- Secondary Outcome Measures
Name Time Method