UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017228
Receipt No. R000019981
Scientific Title Analysis of thrombogenicity in patients with cardiovascular disease
Date of disclosure of the study information 2015/04/21
Last modified on 2016/04/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Analysis of thrombogenicity in patients with cardiovascular disease
Acronym Thrombogenicity and CVD
Scientific Title Analysis of thrombogenicity in patients with cardiovascular disease
Scientific Title:Acronym Thrombogenicity and CVD
Region
Japan

Condition
Condition Cardiovascular disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the thrombogenicity in patients with cardiovascular disease (CVD) using Total Thrombus-formation Analysis System. In particular, we examine the associations between the pathology and progression of CVD and thrombogenicity in acute and chronic CVD. I will elucidate the pathological conditions that thrombogenicity is enhanced. Further, in the treatment of CVD, we also examine whether measurements of thrombogenicity help determine their therapeutic effects, although various anti-platelet and/or anticoagulation therapies are performed,
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Associations between major cardiac events or effects of various treatments and thrombogenicity.
Key secondary outcomes Associations between the presence or absence of CVD and thrombogenicity. Associations between major cardiac events or the effects of various treatments and thrombogenicity.

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine Device,equipment
Interventions/Control_1 The presence and absence of cardiovascular disease
Interventions/Control_2 The presence and absence of medications
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. The presence and absence of cardiovascular disease
2. Age is 20 years old or more.
3. Patients who gave their informed consent to participate for the present study.
Key exclusion criteria 1.Ineligible patients according to the judgment by physician
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keijiro Saku
Organization Fukuoka University School of Medicine
Division name Department of Cardiology
Zip code
Address 7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL 81-92-801-1011
Email saku-k@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shin-ichiro Miura
Organization Fukuoka University School of Medicine
Division name Department of Cardiology
Zip code
Address 7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL 81-92-801-1011
Homepage URL
Email miuras@cis.fukuoka-u.ac.jp

Sponsor
Institute Department of Cardiology, Fukuoka University School of Medicine
Institute
Department

Funding Source
Organization Department of Cardiology, Fukuoka University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 福岡大学病院(Fukuoka University Hospital)

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 21 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 Enrolling by invitation
Date of protocol fixation
2014 Year 05 Month 14 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 21 Day
Last modified on
2016 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019981

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.