UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017228 |
|---|---|
| Receipt number | 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 13:54:40 |
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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
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
miuras@cis.fukuoka-u.ac.jp
Sponsor or person
Institute
Department of Cardiology, Fukuoka University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019981
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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