Understanding of Chest Pain in Microvascular Disease Proved by Cardiac Magnetic Resonance Image (UMPIRE)

This study is currently recruiting participants.
Verified November 2012 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01769482
First received: November 20, 2012
Last updated: March 24, 2014
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Microvascular Angina
Drug: Udenafil
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Understanding of Chest Pain in Microvascular Disease Proved by Cardiac Magnetic Resonance Image

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • to change of frequency of chest pain [ Time Frame: baseline, 3 months after treatment ] [ Designated as safety issue: No ]
  • to change of improvement of ST-depression in ECG [ Time Frame: baseline, 3 months after treatment ] [ Designated as safety issue: No ]
  • to change of QoL(Quality of Life) [ Time Frame: baseline, 3 months after treatment ] [ Designated as safety issue: No ]
  • to change of sexual dysfunction [ Time Frame: baseline, 3 months after treatment ] [ Designated as safety issue: No ]
  • to change of improvement of biomarkers for endothelial function [ Time Frame: baseline and 3 months after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Udenafil
70 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.
Drug: Udenafil
70 subjects will undergo baseline testing and then be randomized into a clinical parallel trial of udenafil 100mg po q d for 3 months.
Other Name: Zydena
Placebo Comparator: Placebo
70 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.
Drug: placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. MVA patients with typical symptom and positive adenosine-stress cardiac MRI and with normal coronary artery in coronary angiogram or coronary artery CT angiography.
  2. Definition of positive adenosine-stress MRI: perfusion defect > 25% of transmurality ( by 2 radiologist based on visual assessment and qualitative assessment in core-lab)
  3. Gender: female
  4. Age: 18-80

Exclusion Criteria:

  1. The patient with contraindication to MR contrast media or MR Imaging
  2. LVEF < 50%
  3. Any heart rhythm abnormality other than sinus rhythm
  4. Valvular heart disease with more than moderate degree
  5. Renal failure
  6. Congestive Heart Failure
  7. Myocardial infraction
  8. Myocarditis
  9. Congenital heart disease
  10. Pericarditis
  11. Variant angina (positive provocation test with Ergonovine or acetylcholine)
  12. GERD (conformed by esophagogastroduodenoscopy)
  13. Pregnant women with suspected, pregnant women or women with lactation
  14. QT prolongation syndrome or take drugs that prolong the QT interval - Antiarrhythmics class IA; quinidine, procainamide - Antiarrhythmics class III; amiodarone, sotalol
  15. Preanalytical within 30 days of screening in a clinical trial that may affect the influence of udenafil

    - Other PDE5 inhibitors (ex. Sildenafil, tadalafil)

    - Nitrates/ NO donor (ex. Nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, amyl nitrate/nitrite, sodium nitroprusside, nicorandil)

  16. Preanalytical within 7 days of screening in a clinical trial that may affect the metabolism of udenafil

    • Antibacterials (ex. Erythromycin)
    • Antifungals (ex. Itraconazole, ketoconazole)
    • Antivirals (ex. Ritonavir, saquinavir, amprenavir, indinavir, nelfinavir)
    • Cimetidine
    • Grapefruit juice
  17. Allergy or sensitivity with PDE 5 inhibitors

    -

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769482

Contacts
Contact: Sung-Ji Park, M.D.,Ph.D. 82-2-3410-0887 tyche.park@gmail.com

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of
Contact: Dong-Ju Choi, M.D.,Ph.D.    82-31-787-7007    djchoi@snu.ac.kr   
Principal Investigator: Dong-Ju Choi, M.D.,Ph.D.         
Korea University Guro Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Eng-Ju Kim, M.D.,Ph.D.         
Principal Investigator: Eng-Ju Kim, M.D.,Ph.D.         
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Sung-Ji Park, M.D.,Ph.D. Samsung Medical Center
  More Information

No publications provided

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01769482     History of Changes
Other Study ID Numbers: 2011-07-048
Study First Received: November 20, 2012
Last Updated: March 24, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
microvascular angina
PDE-5 inhibitors
Heart disease
Ischemia
Cardiac MRI

Additional relevant MeSH terms:
Chest Pain
Microvascular Angina
Pain
Signs and Symptoms
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Udenafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014