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

NCT ID: NCT01769482

Last Updated: 2014-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2014-12-31

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 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.

Conditions

Microvascular Angina

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Udenafil

Intervention Type: DRUG

70 subjects will undergo baseline testing and then be randomized into a clinical parallel trial of udenafil 100mg po q d for 3 months.

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Interventions

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.

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Other Intervention Names

Zydena

Eligibility 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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sung-Ji Park, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status: RECRUITING

Korea University Guro Hospital

Seoul, , South Korea

Site Status: NOT_YET_RECRUITING

Countries

South Korea

Central Contacts

Sung-Ji Park, M.D.,Ph.D.

Role: CONTACT

tyche.park@gmail.com

82-2-3410-0887

Facility Contacts

Dong-Ju Choi, M.D.,Ph.D.

Role: primary

djchoi@snu.ac.kr

82-31-787-7007

Eng-Ju Kim, M.D.,Ph.D.

Role: primary

References

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.

Reference Type: DERIVED

PMID: 25154607 (View on PubMed)

Other Identifiers

2011-07-048

Identifier Type: -

Identifier Source: org_study_id