UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019567 |
|---|---|
| Receipt number | R000022624 |
| Scientific Title | J-COMPASS study(long term study by MPI and CT) |
| Date of disclosure of the study information | 2015/10/30 |
| Last modified on | 2020/11/02 13:15:56 |
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Basic information
Public title
J-COMPASS study(long term study by MPI and CT)
Acronym
J-COMPASS study(long term study by MPI and CT)
Scientific Title
J-COMPASS study(long term study by MPI and CT)
Scientific Title:Acronym
J-COMPASS study(long term study by MPI and CT)
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Long term prognosis in MPI and CTA group
Basic objectives2
Others
Basic objectives -Others
Long term prognosis in MPI and CTA group
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Statistical comparisons of the three groups were based on a time-to-first-event analysis. The primary end-point was the occurrence of a major adverse cardiac event (MACE): cardiac death (sudden death, fatal acute myocardial infarction [MI], death for complication of cardiovascular procedures, fatal heart failure, or fatal stroke), hospitalization for major cardiac event (congestive heart failure, unstable angina, non-fatal MI, or late [>90 days] revascularization). Secondary end-point was included: all-cause death, revascularization therapy, non-fetal MI, readmission for heart failure, readmission for angina, cerebral bleeding, cerebral infarction, bleeding event.
Key secondary outcomes
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.MPI group or CT group
2.Facilities which can cooperate with a investigation
3.Case who did not reject
Key exclusion criteria
1.In primary case who had already J-COMPASS study study,had cardiovascular death.
2.Case who investigator judged as ineligible for this study
Target sample size
1300
Research contact person
Name of lead principal investigator
| 1st name | Nagara |
| Middle name | |
| Last name | Tamaki |
Organization
Hokkaido University
Division name
Nuclear medicine
Zip code
060^8638
Address
Kita-ku, Sapporo-shi north Article 15 west 7
TEL
011-706-5152
ersuzuki@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Suzuki |
Organization
Hokkaido University
Division name
Nuclear medicine
Zip code
060-8638
Address
Kita-ku, Sapporo-shi north Article 15 west 7
TEL
011-706-5152
Homepage URL
ersuzuki@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Japan Heart Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University
Address
North 14, West 5, Kitaku, Sapporo
Tel
011-706-7636
crjimu@huhp.hokudai.ac.jp
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
| 2015 | Year | 10 | Month | 30 | Day |
Related information
URL releasing protocol
None
Publication of results
Partially published
Result
URL related to results and publications
Coron Artery Dis. 2018 Nov;29(7):539-546. doi: 10.1097/MCA.0000000000000645
Number of participants that the trial has enrolled
616
Results
Please see a paper above
Results date posted
| 2019 | Year | 11 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Please see a paper above
Participant flow
Please see a paper above
Adverse events
None
Outcome measures
Please see a paper above
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Long term prognosis in MPI and CTA group
doi:10.1253/circj.CJ-12-0222
Management information
Registered date
| 2015 | Year | 10 | Month | 30 | Day |
Last modified on
| 2020 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022624
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
