UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039746 |
|---|---|
| Receipt number | R000044996 |
| Scientific Title | Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts |
| Date of disclosure of the study information | 2020/03/15 |
| Last modified on | 2020/03/09 13:28:12 |
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Basic information
Public title
Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts
Acronym
ROMA trial
Scientific Title
Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts
Scientific Title:Acronym
ROMA trial
Region
| Japan | Asia(except Japan) | North America |
| Europe |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the utility of second arterial graft conduit, the randomized control trial was conducted.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
he primary outcome will be a composite of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization.
Key secondary outcomes
The secondary outcome will be all cause mortality.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Saphenous vein graft as a 2nd graft conduit after internal thoracic artery.
Interventions/Control_2
Arterial graft ( radial artery, gastroepiploic artery, or contralateral internal thoracic artery) as a 2nd graft conduit after internal thoracic artery.
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
| Not applicable |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria: primary isolated CABG patients with disease of the left main coronary artery or of the left anterior descending and the circumflex coronary system with or without disease of the right coronary artery.
Key exclusion criteria
Age > 70 years
Planned single graft
Emergency operation
Preoperative myocardial infarction within 48 hours
Ejection Fraction (EF) < 35%
Any concomitant cardiac or non-cardiac procedure
Previous cardiac operation
Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure), cancer or any
co-morbidity that reduces life expectancy to less than 5 years.
Inability to use either the saphenous vein or both the right ITA and the RA as grafts
Anticipated need for coronary thrombo-endarterectomy.
Planned hybrid revascularization
Target sample size
3650
Research contact person
Name of lead principal investigator
| 1st name | Hirokuni |
| Middle name | |
| Last name | Arai |
Organization
Tokyo Medical and Dental University
Division name
Department of Cardiovascular Surgery
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5270
office.cvsg@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Eiki |
| Middle name | |
| Last name | Nagaoka |
Organization
Tokyo Medical and Dental University
Division name
Department of Cardiovascular Surgery
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5270
Homepage URL
nagaoka.cvsg@tmd.ac.jp
Sponsor or person
Institute
Weill Cornell Medicine
Institute
Department
Personal name
Funding Source
Organization
no funding source
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review Board TMDU Medical Hospital
Address
1-5-45, Yushima, Bunkyo-ward, Tokyo, Japan
Tel
03-5803-4575
mkan-rinsho.adm@tmd.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
東京医科歯科大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 09 | Day |
Last modified on
| 2020 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044996
