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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001823
Receipt No. R000002190
Scientific Title Prognostic study of ischemic heart diseases in Hokuriku district: prospective investigation for predicting adverse cardiac event rates
Date of disclosure of the study information 2009/04/01
Last modified on 2018/10/08

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Basic information
Public title Prognostic study of ischemic heart diseases in Hokuriku district: prospective investigation for predicting adverse cardiac event rates
Acronym A prospective study for prognosticating adverse cardiac events in Hokuriku
Scientific Title Prognostic study of ischemic heart diseases in Hokuriku district: prospective investigation for predicting adverse cardiac event rates
Scientific Title:Acronym A prospective study for prognosticating adverse cardiac events in Hokuriku
Region
Japan

Condition
Condition ischemic heart disease
Classification by specialty
Cardiology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Prediction of adverse cardiac events in ischemic heart diseases
Basic objectives2 Others
Basic objectives -Others Efficacy of myocardial perfusion imaging
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adverse cardiac events: cardiac death, non-fatal myocardial infarction
Key secondary outcomes Other cardiovascular events

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
20 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Group of ischemic heart disease with ventricular dysfunction
2) Group of normal myocardial perfusion
Key exclusion criteria Cardiomyopathy
Valvular heart disease
Severe liver dysfunction
Renal dysfunction requiring hemodialysis
Acute coronary syndrome within the onset of 3 months
Severe arrhythmia
Severe heart failure of NYHA III or IV
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Nakajima
Organization Kanazawa University
Division name Department of Nuclear Medicine
Zip code
Address 13-1 Takara-machi, Kanazawa
TEL 076-265-2333
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kenichi Nakajima, Shinro Matsuo
Organization Kanazawa University
Division name Department of Nuclear Medicine
Zip code
Address 13-1 Takara-machi, Kanazawa
TEL 076-265-2333
Homepage URL
Email nakajima@med.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University
Institute
Department

Funding Source
Organization Nihon Medi-Physics, Co. Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Toyama Prefectural Central Hospital
Kanazawa Medical Center
Toyama City Hospital
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
2009 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/29317133
Number of participants that the trial has enrolled
Results
Validity of J-ACCESS risk model was confirmed in patients with coronary artery disease (n=283).

J Cardiol. 2018 Jul;72(1):81-86. doi: 10.1016/j.jjcc.2017.12.006. Epub 2018 Jan 6.
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 Completed
Date of protocol fixation
2009 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
2015 Year 04 Month 01 Day
Date trial data considered complete
2015 Year 12 Month 28 Day
Date analysis concluded
2018 Year 08 Month 01 Day

Other
Other related information doi: 10.1016/j.jjcc.2017.12.006. Epub 2018 Jan 6

Management information
Registered date
2009 Year 03 Month 31 Day
Last modified on
2018 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002190

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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