search
Back to results

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

Primary Purpose

Microvascular Angina

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Udenafil
placebo
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Microvascular Angina focused on measuring microvascular angina, PDE-5 inhibitors, Heart disease, Ischemia, Cardiac MRI

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    -

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting
  • Korea University Guro Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Udenafil

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

to change of perfusion defect over 25% of baseline defect in adenosine-stress cardiac MRI after 3-month treatment.

Secondary Outcome Measures

to change of perfusion defect less than 25% of baseline defect in adenosine-stress cardiac MRI after 3-month treatment

Full Information

First Posted
November 20, 2012
Last Updated
March 24, 2014
Sponsor
Samsung Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01769482
Brief Title
Understanding of Chest Pain in Microvascular Disease Proved by Cardiac Magnetic Resonance Image
Acronym
UMPIRE
Official Title
Understanding of Chest Pain in Microvascular Disease Proved by Cardiac Magnetic Resonance Image
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microvascular Angina
Keywords
microvascular angina, PDE-5 inhibitors, Heart disease, Ischemia, Cardiac MRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Udenafil
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Udenafil
Other Intervention Name(s)
Zydena
Intervention Description
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
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Other Pre-specified Outcome Measures:
Title
to change of frequency of chest pain
Time Frame
baseline, 3 months after treatment
Title
to change of improvement of ST-depression in ECG
Time Frame
baseline, 3 months after treatment
Title
to change of QoL(Quality of Life)
Time Frame
baseline, 3 months after treatment
Title
to change of sexual dysfunction
Time Frame
baseline, 3 months after treatment
Title
to change of improvement of biomarkers for endothelial function
Time Frame
baseline and 3 months after treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 - Other PDE5 inhibitors (ex. Sildenafil, tadalafil) - Nitrates/ NO donor (ex. Nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, amyl nitrate/nitrite, sodium nitroprusside, nicorandil) 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 Allergy or sensitivity with PDE 5 inhibitors -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sung-Ji Park, M.D.,Ph.D.
Phone
82-2-3410-0887
Email
tyche.park@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung-Ji Park, M.D.,Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Ju Choi, M.D.,Ph.D.
Phone
82-31-787-7007
Email
djchoi@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Dong-Ju Choi, M.D.,Ph.D.
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eng-Ju Kim, M.D.,Ph.D.
First Name & Middle Initial & Last Name & Degree
Eng-Ju Kim, M.D.,Ph.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
25154607
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs