UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031390 |
|---|---|
| Receipt number | 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 17:00:58 |
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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
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
qqcv2t3d@yahoo.co.jp
Sponsor or person
Institute
Kumamoto univercity hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035841
