UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003839 |
|---|---|
| Receipt number | R000004434 |
| Scientific Title | Case control study for evaluation of the ischemic heart disease diagnosis based on the coronary blood flow measured by intracoronary Flowire in patients suspected angina pectoris |
| Date of disclosure of the study information | 2010/06/30 |
| Last modified on | 2013/01/09 12:18:46 |
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Basic information
Public title
Case control study for evaluation of the ischemic heart disease diagnosis based on the coronary blood flow measured by intracoronary Flowire in patients suspected angina pectoris
Acronym
Diagnosis of the ischemic heart disease by coronary Flowire
Scientific Title
Case control study for evaluation of the ischemic heart disease diagnosis based on the coronary blood flow measured by intracoronary Flowire in patients suspected angina pectoris
Scientific Title:Acronym
Diagnosis of the ischemic heart disease by coronary Flowire
Region
| Japan |
Condition
Condition
Suspected angina pectoris
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of ischemic heart disease by Flowire in patients suspected angina and assessment of the prognosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Significance of diagnosis for ischemic heart disease assessed by intracoronary Flowire
Key secondary outcomes
Prognosis
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Suspected angina pectoris
Key exclusion criteria
Not agreement
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisao Ogawa |
Organization
Kumamoto University Hospital
Division name
Division of Cardiovascular Medicine
Zip code
Address
Honjo 1-1-1, Kumamoto City
TEL
096-373-5175
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seigo Sugiyama |
Organization
Kumamoto University Hospital
Division name
Division of Cardiovascular Medicine
Zip code
Address
Honjo 1-1-1, Kumamoto City
TEL
096-373-5175
Homepage URL
ssugiyam@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kumamoto University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
熊本大学医学部附属病院
Kumamoto University Hospital
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 30 | Day |
Related information
URL releasing protocol
http://jaha.ahajournals.org/content/1/5/e002485.full
Publication of results
Published
Result
URL related to results and publications
http://jaha.ahajournals.org/content/1/5/e002485.full
Number of participants that the trial has enrolled
Results
Three hundred seventy consecutive, stable patients with suspected angina presenting nonobstructive coronary arteries (<50% diameter) in coronary angiography were investigated with the intracoronary acetylcholine provocation test, with simultaneous measurements of transcardiac lactate production and of changes in the quantitative coronary blood flow. We diagnosed microvascular CAS according to lactate production and a decrease in coronary blood flow without epicardial vasospasm during the acetylcholine provocation test. We prospectively followed up the patients with calcium channel blockers for microvascular coronary artery disease. We identified 50 patients with microvascular CAS who demonstrated significant impairment of the endothelium-dependent vascular response, which was assessed by coronary blood flow during the acetylcholine provocation test. Administration of isosorbide dinitrate normalized the abnormal coronary flow pattern in the patients with microvascular CAS.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2002 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2002 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 08 | Month | 02 | Day |
Other
Other related information
Multivariate logistic regression analysis indicated that female sex, a lower body mass index, minor or borderline ischemic electrocardiogram findings at rest, limited baseline diastolic to systolic velocity ratio, and attenuated adenosine triphosphate induced coronary flow reserve were independently correlated with the presence of microvascular CAS. Receiver operating characteristics curve analysis revealed that the aforementioned 5 variable model showed good correlation with the presence of microvascular CAS (area under the curve: 0.820). No patients with microvascular CAS treated with calcium channel blockers developed cardiovascular events over 47.8+-27.5 months.
Management information
Registered date
| 2010 | Year | 06 | Month | 29 | Day |
Last modified on
| 2013 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004434
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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