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

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 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


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

Value
https://center6.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