UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Relation between Impairment of Endothelium-dependent Coronary Blood Flow Volume Change and Higher Platelet Aggregability
Title of the study (Brief title)	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	Kenji Tsujita
Organization	Kumamoto univercity hospital
Division name	cardiology
Address	1-1-1 Honjo Tyuouku Kumamotoshi
TEL	0963735175
Email	tsujita@kumamoto-u.ac.jp

Public contact
Name of contact person	Masafumi Takae
Organization	Kumamoto univercity hospital
Division name	cardiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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