UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prognostic study of risk reduction among Japanese ischemic heart disease patients with coronary revascularization using quantitative analysis of gated myocardial perfusion SPECT
Title of the study (Brief title)	Multicenter study for assessment of usefulness of gated myocardial perfusion SPECT in patients receiving revascularization therapy (J-ACCESS4)
Region	Japan

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

Objectives
Narrative objectives1	To evaluate weather revascularization therapy reduce for cardiac events risk assessed by 99mTc-Tetrofosmin 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, Non-cardiac death, Hospitalization of heart failure
Key secondary outcomes	Non fatal myocardial infarction, Hospitalization for unstable angina, Stroke, Coronary or peripheral artery infarction, Receiving PCI or CABG

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)Ischemic heart disease (IHD) patients (include suspected IHD and history of revascularization) with at least one of following symptom/findings 1)Angina or equivalent chest pain 2)Suspected IHD due to newly shortening of breath/ palpitation 3)Findings of IHD by ECG (2)Patient>=20 years old and received written informed consent (3)SPECT study performed indicated time period
Key exclusion criteria	(1)ACS patient within 3 months prior to registration (2)History of old myocardial infarction with following category 1)History of higher cardiac enzyme(CK or CK-MB more than twice of normal level or elevation of Troponin) 2) Finding of new Q wave by more than adjacent 2 lead by ECG 3) Certified non viable myocardium by cardiac imaging test (3)patients with dialysis or peritoneal dialysis (4)valvular disease necessary to surgical therapy (5) Also diagnosed HCM or DCM (6) Heart failure >= NYHA3 (7)Difficult to study Gated SPECT due to arrhythmia (8) Drug hypersensitivity with Tetrofosmin or analogous drug (9)Unsuitable for registration by investigator
Target sample size	500

Research contact person
Name of lead principal investigator	Tsunehiko Nishimura
Organization	Kyoto Prefectural Medical University
Division name	Radiology
Address	465 Kajii-cho, Kawaramachi-dori hirokoji agaru Kamigyo-ku, Kyoto 602-0841 JAPAN
TEL	075-741-7212
Email	nisimura@koto.kpu-m.ac.jp

Public contact
Name of contact person	Kenji Ichioka
Organization	Japan Cardiovascular research foundation
Division name	J-ACCESS office
Address	1-4-1, senri-higashicho
TEL	06-6155-1003
Homepage URL	http://www.j-access.jp/j-access4.html
Email	jimu@j-access.jp

Sponsor
Institute	Japan Cardiovascular research foundation
Institute
Department

Funding Source
Organization	Japan 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)

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	北海道／Hokkaido 山形県／Yamagata-ken 福島県／Fukushima-ken 茨城県／Ibaraki-ken 群馬県／Gunma-ken 埼玉県／Saitama-ken 神奈川県／Kanagawa-ken 東京都／Tokyo-to 愛知県／Aichi-ken 静岡県／Shizuoka-ken 岐阜県／Gifu-ken 長野県／Nagano-ken 京都府／Kyoto-fu 石川県／Ishikawa-ken 滋賀県／Shiga-ken 富山県／Toyama-ken 大阪府／Osaka-fu 兵庫県／Hyogo-ken 香川県／Kagawa-ken 愛媛県／Ehime-ken 岡山県／Okayama-ken 長崎県／Nagasaki-ken 福岡県／Fukuoka-ken 熊本県／Kumamoto-ken

Other administrative information
Date of disclosure of the study information	2012 Year 05 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 09 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date	2015 Year 12 Month 31 Day
Date of closure to data entry	2016 Year 01 Month 31 Day
Date trial data considered complete	2016 Year 05 Month 31 Day
Date analysis concluded	2016 Year 12 Month 31 Day

Related information
URL releasing protocol	http://www.j-access.jp/j-access4.html
Publication of results	Unpublished
URL releasing results
Results
Other related information	Nishimura 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. Cardiac event correlated with myocardial SPECT parameter and able to stratifying event risk quantitatively.

Management information
Registered date	2012 Year 05 Month 29 Day
Last modified on	2016 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009479