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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031390
Receipt No. R000035841
Scientific Title The Relation between Impairment of Endothelium-dependent Coronary Blood Flow Volume Change and Higher Platelet Aggregability
Date of disclosure of the study information 2018/02/28
Last modified on 2018/02/20

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Basic information
Public title The Relation between Impairment of Endothelium-dependent Coronary Blood Flow Volume Change and Higher Platelet Aggregability
Acronym Endothelial function and platelet aggregability
Scientific Title The Relation between Impairment of Endothelium-dependent Coronary Blood Flow Volume Change and Higher Platelet Aggregability
Scientific Title:Acronym Endothelial function and platelet aggregability
Region
Japan

Condition
Condition healthy person
Classification by specialty
Cardiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Thrombus formation is one of the main pathogenesis of myocardial infarction. Previous studies have reported that atherosclerosis can increase platelet aggregability. Endothelial dysfunction reflects early change of atherosclerosis. However, the relation between coronary-endothelial dysfunction and platelet reactivity remains unclear. We investigated the relation between endothelium-dependent coronary blood flow volume change and platelet aggregability in non-obstructive ischemic heart disease (IHD) patients who did not take any anti-platelet therapy.
Basic objectives2 Others
Basic objectives -Others Thrombus formation is one of the main pathogenesis of myocardial infarction. Previous studies have reported that atherosclerosis can increase platelet aggregability. Endothelial dysfunction reflects early change of atherosclerosis. However, the relation between coronary-endothelial dysfunction and platelet reactivity remains unclear. We investigated the relation between endothelium-dependent coronary blood flow volume change and platelet aggregability in non-obstructive ischemic heart disease (IHD) patients who did not take any anti-platelet therapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Consecutive 368 patients suspected angina with normal coronary arteries were initially enrolled. We performed coronary angiography and intracoronary acetylcholine-provocation test, and measured adenosine triphosphate-induced coronary flow reserve (CFR) to diagnose the presence of non-obstructive IHD by using Doppler FloWire at the proximal site of left anterior descending coronary artery before taking any vasodilators at the basal non-stress condition. Then, we excluded patients who take any anti-platelet agents from 62 patients with non-obstructive IHD. Finally, 25 non-obstructive IHD patients were assessed the relation between CBFV change and platelet aggregability as P2Y12 reaction unit (PRU) by VerifyNow P2Y12 assay system.
Key secondary outcomes

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The study screened stable patients suspected angina who admitted Kumamoto Univercity Hospital between January 2002 to April 2011. We performed coronary angiography (CAG), intracoronary acetylcholine-provocation test and measured coronrary flow reserve (CFR) to diagnose angina, and we excluded patients with ischemic heart disease (IHD) and vasospastic angina. Then we also excluded patients with took antithrombotic drugs. We finally enrolled 25 patients without obstructive or spastic angina were assessed the relation between CBFV and platelet aggregability.
Key exclusion criteria we excluded patients who take any anti-platelet agents from 62 patients with non-obstructive IHD.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Tsujita
Organization Kumamoto univercity hospital
Division name cardiology
Zip code
Address 1-1-1 Honjo Tyuouku Kumamotoshi
TEL 0963735175
Email tsujita@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masafumi Takae
Organization Kumamoto univercity hospital
Division name cardiology
Zip code
Address 1-1-1 Honjo Tyuouku Kumamotoshi
TEL 0963735175
Homepage URL
Email qqcv2t3d@yahoo.co.jp

Sponsor
Institute Kumamoto univercity hospital
Institute
Department

Funding Source
Organization Kumamoto univercity hospital
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 28 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
2012 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2018 Year 02 Month 20 Day
Last modified on
2018 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035841

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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