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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003839
Receipt No. 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

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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
Email

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
Email ssugiyam@kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004434

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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