UMIN-CTR Clinical Trial

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
Email	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
Email	nagaoka.cvsg@tmd.ac.jp

Sponsor
Institute	Weill Cornell Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044996