UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of thrombogenicity in patients with cardiovascular disease
Title of the study (Brief title)	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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Keijiro Saku
Organization	Fukuoka University School of Medicine
Division name	Department of Cardiology
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	Shin-ichiro Miura
Organization	Fukuoka University School of Medicine
Division name	Department of Cardiology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 05 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000019981