UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008050 |
|---|---|
| Receipt number | 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 11:07:27 |
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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
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
| 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
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
jimu@j-access.jp
Sponsor or person
Institute
Japan Cardiovascular research foundation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009479
