Clinical Trial: Understanding of Chest Pain in Microvascular Disease Proved by Cardiac Magnetic Resonance Image
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Understanding of Chest Pain in Microvascular Disease Proved by Cardiac Magnetic Resonance Image
Brief Summary:
Current therapeutic options for a well-recognized group of patients with anginal symptoms—a positive exercise tolerance testing, SPECT or perfusion defect in MRI but angiographically normal coronary arteries—are limited. The condition, referred to as microvascular angina (MVA) or cardiac syndrome X, is not as benign as originally reported—patients presenting with unstable angina and nonobstructive atherosclerotic coronary artery disease have a 2% risk of death or myocardial infarction at 30 days of follow-up. It is more common in women in whom the first presentation of angina occurs either perimenopausally or postmenopausally. Aberrant flow-mediated coronary vasomotion is pivotal in the pathogenesis (systemic) impairment in endothelial function. Indeed, some centers use systemic assessments of vascular function in their diagnostic pathways for this group of women. It was recently suggested that endothelial dysfunction may lead to myocardial ischemia.
In the present study, the investigators tested the hypothesis that udenafil offers dual benefits of improving vascular function and lessening ischemia in women with angina, perfusion defect in cardiac MRI, and normal coronary arteries.
Detailed Summary:
The aim of this study is that udenafil offers dual benefits of improving vascular function and lessening ischemia in women with microvascular angina, perfusion defect in cardiac MRI, and normal coronary arteries.
The UMPIRE trial is a multi-center, prospective, randomized, placebo controlled trial, designed to evaluate the effect of udenafil in improvement of myocardial stress perfusion defect in cardiac MRI, in women patients with microvascular angina. A total of 70 patients will be randomized to udenafil(100 mg q d) or placebo treatment. The primary end point of the study is Change of perfusion defect over 25% of baseline defect in adenosine-stress cardiac MRI after 3-month treatment. The secondary endpoints of this study are change of perfusion defect less than 25% of baseline defect in adenosine-stress cardiac MRI after 3-month treatment, decrement of frequency of chest pain, improvement of ST-depression in stress test, improvement of duke score in stress test, improvement of QoL assessment by SF-36 questionnaire, improvement of sexual dysfunction assessment by BISF-W self-questionnaire and improvement of biomarkers foe endothelial function.
Sponsor: Samsung Medical Center
Current Primary Outcome: to change of perfusion defect over 25% of baseline defect in adenosine-stress cardiac MRI after 3-month treatment. [ Time Frame: baseline, 3 months after treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome: to change of perfusion defect less than 25% of baseline defect in adenosine-stress cardiac MRI after 3-month treatment [ Time Frame: baseline, 3 months after treatment ]
Original Secondary Outcome: Same as current
Information By: Samsung Medical Center
Dates:
Date Received: November 20, 2012
Date Started: December 2011
Date Completion: December 2014
Last Updated: March 24, 2014
Last Verified: November 2012
