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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000001899
Receipt No. R000002298
Scientific Title Prognostic study of risk stratification among Japanese patients with chronic kidney disease and ischemic heart disease using gated myocardial perfusion SPECT
Date of disclosure of the study information 2009/04/30
Last modified on 2012/04/20

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Basic information
Public title Prognostic study of risk stratification among Japanese patients with chronic kidney disease and ischemic heart disease using gated myocardial perfusion SPECT
Acronym J-ACCESS III
Scientific Title Prognostic study of risk stratification among Japanese patients with chronic kidney disease and ischemic heart disease using gated myocardial perfusion SPECT
Scientific Title:Acronym J-ACCESS III
Region
Japan

Condition
Condition Chronic kidney disease, Ischemic heart disease
Classification by specialty
Cardiology Nephrology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether incidence of cardiovascular event in chronic kidney disease patients with risk factors could be stratified by gated myocardial perfusion SPECT
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cardiac death, Sudden death
Key secondary outcomes on fatal myocardial infarction,
first hospitalization for heart failure or unstable angina, stroke, coronary or peripheral revascularization.
Performed PCI or CABG, Introduce dialysis, the first event of the composite end point of a doubling of the serum creatinine concentration.

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) Age above 20
2) Chronic kidney disease with following A and/or B
A. Below estimated glomerular filtration(eGFR)50mL/min/1.73m2
B. Serum creatinine concentration over1.5mg/dL(Male), 1.2mg/dL(Female)
3) Patient with at least one or more following risk factors:
Hypertension, Diabetes, hyperlipidemia, Peripheral artery disease , Current smoking, Family history of coronary heart disease, history of stroke
4) Possible to SPECT study within 2 months before or after registration
5) Patients who are obtained informed consent
6) Patients with following symptom or findings but not confirmed definitive diagnosis:
A. Angina or equivalent symptoms
B. Suspected ischemic heart disease with new breath shortness or pulsation
C. Suspected ischemic heart disease by electric cardiogram
Key exclusion criteria 1) patients with dialysis or peritoneal dialysis
2) valvular disease nessesary to operation
3) HCM or DCM
4) History of myocardial infarction or angina before registration. Hiiistory of revascularization.
5) Coronary angiography or CT angiography within 2 months before registration
6) drug hypersensitivity with Tetrofosmin or analogous drug
7) Difficult to study Gated SPECT due to arrhythmias
8) Contraindication of adenosine such as spasmodic asthma
9) Unsuitable for registration by investigator
Target sample size 800

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsunehiko Nishimura
Organization Kyoto prefectural Medical university
Division name Radiology
Zip code
Address 465 Kajii-machi, Kawaramachi-dori hirokoji agaru Kamigyo-ku, Kyoto city
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Cardiovascular research foundation
Division name J-ACCESS office
Zip code
Address 1-4-1, Senri-higashimachi, Toyonaka city, Osaka
TEL 06-6155-1003
Homepage URL
Email jimu@j-access.jp

Sponsor
Institute Cardiovascular research foundation
Institute
Department

Funding Source
Organization Cardiovascular research foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2009 Year 04 Month 30 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 Open public recruiting
Date of protocol fixation
2009 Year 02 Month 23 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Nishimur T, Nakajima K, et al., Prognostic study of risk stratification among Japanese patients with ischemic heart disease using gated myocardial perfusion SPECT: J-ACCESS study. Eur J Nucl Med Mol Imaging 35:319-328, 2008.
J-ACCESS study has been reported above paper including 4,031 IHD patients.
A sub-study of J-ACCESS concerning cardiovascular event with CKD patients are significantly related with MPI parameters.
MPI is the powerful tool for risk stratifying in CKD patients of cardiovascular event.
(manuscript in submission)

Management information
Registered date
2009 Year 04 Month 20 Day
Last modified on
2012 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002298

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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