Status:
TEMPORARILY_NOT_AVAILABLE
Improvement of Myocardial Blood Flow by PhosphoDiesterase 5 Inhibition in Coronary Artery Disease
Lead Sponsor:
Medical University of Vienna
Conditions:
Therapy Refractory Myocardial Ischemia
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
The aim of this study is to prospectively investigate if intermittent Phosphodiesterase 5 inhibition for 15 weeks improves myocardial perfusion by angiogenesis in patients with therapy refractory myoc...
Detailed Description
This study is designed as a randomized, double-blind, placebo controlled monocentric study. Patients will be randomized to two groups; PDE5 inhibitor (vardenafil) or placebo taken as one tablet twice...
Eligibility Criteria
Inclusion
- Stable angina pectoris
- Evidence for myocardial ischemia according to the presence of one or more of the followings:
- Typical angina during exercise test or
- Significant reversible perfusion defects on dipyridamole myocardial radionuclide study
- Coronary artery disease of at least one large epicardial coronary artery with ≥70% stenosis remaining from which new collaterals/vessels could be supplied
- Coronary artery disease judged to be unsuitable for surgical or percutaneous revascularisation ƒdue to extensive atherosclerosis
- Optimized anti-ischemic drug therapy (including beta-blocker therapy with at least 50% target dose)
- Subject must be willing and able to give informed consent Eligible patients must fulfill all 6 inclusion criteria.
Exclusion
- STEMI or NSTEMI within the past 3 months
- Revascularisation procedures within the last 3 months
- Severely reduced systolic left ventricular function EF \< 30%
- Systolic blood pressure \<120mmHg
- Chronic renal insufficiency with a serum creatinine \>2.5mg/dl
- Diabetes mellitus with proliferative retinopathy
- Diagnosed or suspected cancer
- Chronic inflammatory disease
- Therapy with nitrates and nicorandil
- Women who are pregnant or lactating
- Patients with a total occluded vessel and reversible perfusion defects at the marginal zone of scare tissue if they have no additional stenosed vessels causing significant reversible perfusion defects.
- Patients with a total occluded vessel and perfusion defect at rest despite evidence of vital myocardium, if they have no additional stenosed vessels causing significant reversible perfusion defects.
- Eligible patients must demonstrate none of the exclusion criteria.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01406535
Last Update
August 1 2011
Active Locations (1)
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1
Rudolf Berger, MD
Vienna, Vienna, Austria, 1090