UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Completed
Unique ID issued by UMIN UMIN000008050
Receipt No. R000009479
Scientific Title Prognostic study of risk reduction among Japanese ischemic heart disease patients with coronary revascularization using quantitative analysis of gated myocardial perfusion SPECT
Date of disclosure of the study information 2012/05/31
Last modified on 2016/11/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prognostic study of risk reduction among Japanese ischemic heart disease patients with coronary revascularization using quantitative analysis of gated myocardial perfusion SPECT
Acronym Multicenter study for assessment of usefulness of gated myocardial perfusion SPECT in patients receiving revascularization therapy (J-ACCESS4)
Scientific Title Prognostic study of risk reduction among Japanese ischemic heart disease patients with coronary revascularization using quantitative analysis of gated myocardial perfusion SPECT
Scientific Title:Acronym 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
1st name
Middle name
Last name Tsunehiko Nishimura
Organization Kyoto Prefectural Medical University
Division name Radiology
Zip code
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
1st name
Middle name
Last name Kenji Ichioka
Organization Japan Cardiovascular research foundation
Division name J-ACCESS office
Zip code
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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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 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

Related information
URL releasing protocol http://www.j-access.jp/j-access4.html
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 Completed
Date of protocol fixation
2012 Year 04 Month 09 Day
Date of IRB
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

Other
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


Contact us.