UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001823 |
|---|---|
| Receipt number | 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 18:40:03 |
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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
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
nakajima@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002190
