Understanding of Chest Pain in Microvascular Disease Proved by Cardiac Magnetic Resonance Image
UMPIRE
1 other identifier
interventional
70
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2011
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 20, 2012
CompletedFirst Posted
Study publicly available on registry
January 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMarch 26, 2014
November 1, 2012
3 years
November 20, 2012
March 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
to change of perfusion defect over 25% of baseline defect in adenosine-stress cardiac MRI after 3-month treatment.
baseline, 3 months after treatment
Secondary Outcomes (1)
to change of perfusion defect less than 25% of baseline defect in adenosine-stress cardiac MRI after 3-month treatment
baseline, 3 months after treatment
Other Outcomes (5)
to change of frequency of chest pain
baseline, 3 months after treatment
to change of improvement of ST-depression in ECG
baseline, 3 months after treatment
to change of QoL(Quality of Life)
baseline, 3 months after treatment
- +2 more other outcomes
Study Arms (2)
Udenafil
EXPERIMENTAL70 subjects will undergo baseline testing and then be randomized into a clinical parallel trial of udenafil 100mg or placebo po q d for 3 months.
Placebo
PLACEBO COMPARATOR70 subjects will undergo baseline testing and then be randomized into a clinical parallel trial of udenafil 100mg or placebo po q d for 3 months.
Interventions
Eligibility Criteria
You may qualify if:
- MVA patients with typical symptom and positive adenosine-stress cardiac MRI and with normal coronary artery in coronary angiogram or coronary artery CT angiography.
- Definition of positive adenosine-stress MRI: perfusion defect \> 25% of transmurality ( by 2 radiologist based on visual assessment and qualitative assessment in core-lab)
- Gender: female
- Age: 18-80
You may not qualify if:
- The patient with contraindication to MR contrast media or MR Imaging
- LVEF \< 50%
- Any heart rhythm abnormality other than sinus rhythm
- Valvular heart disease with more than moderate degree
- Renal failure
- Congestive Heart Failure
- Myocardial infraction
- Myocarditis
- Congenital heart disease
- Pericarditis
- Variant angina (positive provocation test with Ergonovine or acetylcholine)
- GERD (conformed by esophagogastroduodenoscopy)
- Pregnant women with suspected, pregnant women or women with lactation
- QT prolongation syndrome or take drugs that prolong the QT interval - Antiarrhythmics class IA; quinidine, procainamide - Antiarrhythmics class III; amiodarone, sotalol
- Preanalytical within 30 days of screening in a clinical trial that may affect the influence of udenafil
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Seoul National University Bundang Hospital
Seongnam, South Korea
Korea University Guro Hospital
Seoul, South Korea
Related Publications (1)
Park SJ, Park JJ, Choi DJ, Chun EJ, Choi SI, Kim SM, Jang SY, Ahn S, Choe YH. Understanding of chest pain in microvascular disease proved by cardiac magnetic resonance image (UMPIRE): study protocol for a randomized controlled trial. Trials. 2014 Aug 26;15:333. doi: 10.1186/1745-6215-15-333.
PMID: 25154607DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sung-Ji Park, M.D.,Ph.D.
Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2012
First Posted
January 16, 2013
Study Start
December 1, 2011
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
March 26, 2014
Record last verified: 2012-11