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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000247
Receipt No. R000000310
Scientific Title Carotid-artery Intima irregurality as a risk factor for cardiovascular disease -observational prospective cohort study
Date of disclosure of the study information 2006/04/01
Last modified on 2008/11/04

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Basic information
Public title Carotid-artery Intima irregurality as a risk factor for cardiovascular disease
-observational prospective cohort study
Acronym Hakodate Atherosclerosis Study
Scientific Title Carotid-artery Intima irregurality as a risk factor for cardiovascular disease
-observational prospective cohort study
Scientific Title:Acronym Hakodate Atherosclerosis Study
Region
Japan

Condition
Condition arterial sclerosis
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the associations between the irregularity of the carotid artery
intima and the incidence of cardiovascular diseas
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes cardiovascular death, cardiovascular disease
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 Arterial sclerosis
Key exclusion criteria aortitis syndrome
cartid artery endarterectomy
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeo Nakajima
Organization Nakajima clinic
Division name Nakajima clinic
Zip code
Address 19-13, Omori-cho, Hakodate, Hokkaido, 040-0034, Japan
TEL 0138-22-4357
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shigeo Nakajima
Organization Hakodate atherosclerosis study group
Division name Hakodate atherosclerosis study group
Zip code
Address 19-13, Omori-cho, Hakodate, Hokkaido, 040-0034, Japan
TEL 0138-22-4357
Homepage URL
Email shigshig@gmail.com

Sponsor
Institute Nakajima clinic
Institute
Department

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
2006 Year 04 Month 01 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 No longer recruiting
Date of protocol fixation
2000 Year 10 Month 28 Day
Date of IRB
Anticipated trial start date
2000 Year 11 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
2010 Year 03 Month 01 Day
Date trial data considered complete
2010 Year 03 Month 01 Day
Date analysis concluded
2010 Year 06 Month 01 Day

Other
Other related information To study carotid artery intima irregularity

Management information
Registered date
2005 Year 09 Month 21 Day
Last modified on
2008 Year 11 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000310

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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