UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016651
Receipt number R000019320
Scientific Title The effect of vascular function in patients with cardiovascular disease.
Date of disclosure of the study information 2015/02/26
Last modified on 2016/02/14 17:15:15

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Basic information

Public title

The effect of vascular function in patients with cardiovascular disease.

Acronym

The effect of vascular function

Scientific Title

The effect of vascular function in patients with cardiovascular disease.

Scientific Title:Acronym

The effect of vascular function

Region

Japan


Condition

Condition

Cardiovascular disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effct of vascular fuction for the clinical parameters (blood sample, ECG, UCG, CT, MRI, IVUS, OCT, etc) and prognosis in patients with cardiovascular disease.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

prognosis

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients with cardiovascular disease.
2)Patients providing written consent for participation in this study on their own volition after receving a through explanation about the study.

Key exclusion criteria

1) Patients with unwillingness to
participate or Patients whose conset could not be aquired.
2)Patients judged to be unsuitable for participation for medical reason.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuo Kimura

Organization

Yokohama City University Medical Center

Division name

Division of Cardiology

Zip code


Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

+81-45-261-5656

Email

c-kimura@urahp.yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masaomi Gohbara

Organization

Yokohama City University Medical Center

Division name

Division of Cardiology

Zip code


Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

+81-45-261-5656

Homepage URL


Email

gocchi3@hotmail.com


Sponsor or person

Institute

Yokohama City University Medical Center

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2015 Year 02 Month 26 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

We analyzed the patients limitted to acute coronary syndrome (scheduled sample size was 285) in regard to CAVI, and submitted a paper to a journal.

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

Open public recruiting

Date of protocol fixation

2012 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 01 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

To assess the impact of vascular function determined by CAVI, ba-PWV, and EndoPAT on the prognosis.


Management information

Registered date

2015 Year 02 Month 26 Day

Last modified on

2016 Year 02 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019320


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name