Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04124120




Registration number
NCT04124120
Ethics application status
Date submitted
10/10/2019
Date registered
11/10/2019

Titles & IDs
Public title
Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women
Scientific title
Randomized Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women (ROMA:Women) Trial
Secondary ID [1] 0 0
1703018094-ROMA-Women
Universal Trial Number (UTN)
Trial acronym
ROMA:Women
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Diseases 0 0
Coronary Artery Disease 0 0
Coronary Artery Bypass Grafting 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Single arterial graft
Treatment: Surgery - Multiple arterial grafting

Experimental: Single Arterial Graft (SAG) group - Patients in this group will receive a single arterial graft which will be the left internal thoracic artery. Additional grafts used in this group will all be venous grafts.

Experimental: Multiple Arterial Graft (MAG) group - Patients in the group will receive multiple arterial grafts. All patients will receive at least two arterial grafts, the left internal thoracic artery with the addition of either the right internal thoracic artery or the radial artery as the second conduit. Some patients may receive additional arterial grafts consisting of the radial artery, the right internal thoracic artery, or the right gastroepiploic artery.


Treatment: Surgery: Single arterial graft
This interventions consists of patients receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. In addition to the left internal thoracic artery patients will receive venous grafts for all additional grafting.

Treatment: Surgery: Multiple arterial grafting
This intervention consists of the patient receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. The second arterial graft (right internal thoracic artery or radial artery) will be directed to the major branch of the circumflex. Additional grafts will include saphenous veins or arterial conduits.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary outcome for aim 1: Death from any cause, any stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.
Timepoint [1] 0 0
Postoperatively, minimum 2.5 year follow-up
Primary outcome [2] 0 0
Primary outcome for aim 2: Disease-specific quality of life
Timepoint [2] 0 0
Postoperatively, minimum 2.5 year follow-up
Secondary outcome [1] 0 0
Death from any cause, any stroke, non-procedural myocardial infarction, and repeat revascularization.
Timepoint [1] 0 0
Postoperatively, minimum 2.5 year follow-up
Secondary outcome [2] 0 0
Death from cardiac cause, any stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.
Timepoint [2] 0 0
Postoperatively, minimum 2.5 year follow-up
Secondary outcome [3] 0 0
Death from any cause
Timepoint [3] 0 0
Postoperatively, minimum 2.5 year follow-up
Secondary outcome [4] 0 0
Stroke
Timepoint [4] 0 0
Postoperatively, minimum 2.5 year follow-up
Secondary outcome [5] 0 0
Non-procedural myocardial infarction
Timepoint [5] 0 0
> 48 hours postoperatively, minimum 2.5 year follow-up
Secondary outcome [6] 0 0
Repeat revascularization
Timepoint [6] 0 0
Postoperatively, minimum 2.5 year follow-up
Secondary outcome [7] 0 0
Readmission for acute coronary syndrome
Timepoint [7] 0 0
Postoperatively, minimum 2.5 year follow-up
Secondary outcome [8] 0 0
Readmission for heart failure
Timepoint [8] 0 0
Postoperatively, minimum 2.5 year follow-up
Secondary outcome [9] 0 0
Generic quality of life according to the Short Form Health Survey (SF-12v2)
Timepoint [9] 0 0
Postoperatively, minimum 2.5 year follow-up
Secondary outcome [10] 0 0
Generic quality of life according to EuroQuol-5D (EQ-5D)
Timepoint [10] 0 0
Postoperatively, minimum 2.5 year follow-up
Secondary outcome [11] 0 0
Mental and physical health symptoms according to PROMIS instruments
Timepoint [11] 0 0
Postoperatively, minimum 2.5 year follow-up

Eligibility
Key inclusion criteria
1. Women patients =18 years old.
2. Isolated coronary artery bypass grafting.
3. Primary (first time) cardiac surgery procedure.
4. Significant 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Male gender
* Single graft
* Emergency operation
* Myocardial infarction within 72 hours of surgery
* Left ventricular ejection fraction < 35%
* Any concomitant cardiac or non-cardiac procedure
* Previous cardiac surgery
* 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 the saphenous vein or to use both radial and right internal thoracic arteries
* Anticipated need for coronary thrombo-endarterectomy
* Planned hybrid revascularization

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2030
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Rhode Island
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
Austria
State/province [18] 0 0
Graz
Country [19] 0 0
Austria
State/province [19] 0 0
Innsbruck
Country [20] 0 0
Austria
State/province [20] 0 0
Linz
Country [21] 0 0
Austria
State/province [21] 0 0
Vienna
Country [22] 0 0
Brazil
State/province [22] 0 0
Porto Alegre
Country [23] 0 0
Brazil
State/province [23] 0 0
São Paulo
Country [24] 0 0
Brazil
State/province [24] 0 0
Vila Mariana
Country [25] 0 0
Canada
State/province [25] 0 0
Manitoba
Country [26] 0 0
Canada
State/province [26] 0 0
New Brunswick
Country [27] 0 0
Canada
State/province [27] 0 0
Newfoundland and Labrador
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
Canada
State/province [30] 0 0
Montréal
Country [31] 0 0
Canada
State/province [31] 0 0
New Westminster
Country [32] 0 0
China
State/province [32] 0 0
Beijing
Country [33] 0 0
China
State/province [33] 0 0
Jilin
Country [34] 0 0
China
State/province [34] 0 0
Shanghai
Country [35] 0 0
China
State/province [35] 0 0
Tianjin
Country [36] 0 0
Croatia
State/province [36] 0 0
Zagreb
Country [37] 0 0
Czechia
State/province [37] 0 0
Hradec Králové
Country [38] 0 0
Czechia
State/province [38] 0 0
Nové Mesto
Country [39] 0 0
Denmark
State/province [39] 0 0
Aalborg
Country [40] 0 0
Denmark
State/province [40] 0 0
Copenhagen
Country [41] 0 0
Germany
State/province [41] 0 0
Baden-Wuerttemberg
Country [42] 0 0
Germany
State/province [42] 0 0
Bad Oeynhausen
Country [43] 0 0
Germany
State/province [43] 0 0
Berlin
Country [44] 0 0
Germany
State/province [44] 0 0
Duisburg
Country [45] 0 0
Germany
State/province [45] 0 0
Düsseldorf
Country [46] 0 0
Germany
State/province [46] 0 0
Erlangen
Country [47] 0 0
Germany
State/province [47] 0 0
Essen
Country [48] 0 0
Germany
State/province [48] 0 0
Frankfurt
Country [49] 0 0
Germany
State/province [49] 0 0
Gießen
Country [50] 0 0
Germany
State/province [50] 0 0
Göttingen
Country [51] 0 0
Germany
State/province [51] 0 0
Jena
Country [52] 0 0
Germany
State/province [52] 0 0
Leipzig
Country [53] 0 0
Germany
State/province [53] 0 0
Stuttgart
Country [54] 0 0
Germany
State/province [54] 0 0
Trier
Country [55] 0 0
India
State/province [55] 0 0
Tamil Nadu
Country [56] 0 0
India
State/province [56] 0 0
Telangana
Country [57] 0 0
Israel
State/province [57] 0 0
Haifa
Country [58] 0 0
Italy
State/province [58] 0 0
Bari
Country [59] 0 0
Italy
State/province [59] 0 0
Bergamo
Country [60] 0 0
Italy
State/province [60] 0 0
Brescia
Country [61] 0 0
Italy
State/province [61] 0 0
Cotignola
Country [62] 0 0
Italy
State/province [62] 0 0
Florence
Country [63] 0 0
Italy
State/province [63] 0 0
Roma
Country [64] 0 0
Italy
State/province [64] 0 0
Torino
Country [65] 0 0
Japan
State/province [65] 0 0
Tokyo
Country [66] 0 0
Japan
State/province [66] 0 0
Saitama
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Seoul
Country [68] 0 0
Korea, Republic of
State/province [68] 0 0
Seúl
Country [69] 0 0
Netherlands
State/province [69] 0 0
Maastricht
Country [70] 0 0
North Macedonia
State/province [70] 0 0
Skopje
Country [71] 0 0
Poland
State/province [71] 0 0
Katowice
Country [72] 0 0
Poland
State/province [72] 0 0
Zabrze
Country [73] 0 0
Portugal
State/province [73] 0 0
Coimbra
Country [74] 0 0
Portugal
State/province [74] 0 0
Lisboa
Country [75] 0 0
Portugal
State/province [75] 0 0
Porto
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Tomsk
Country [77] 0 0
Serbia
State/province [77] 0 0
Belgrade
Country [78] 0 0
Singapore
State/province [78] 0 0
Singapore
Country [79] 0 0
Spain
State/province [79] 0 0
Alicante
Country [80] 0 0
Spain
State/province [80] 0 0
Barcelona
Country [81] 0 0
Spain
State/province [81] 0 0
Madrid
Country [82] 0 0
Spain
State/province [82] 0 0
Pamplona
Country [83] 0 0
Sweden
State/province [83] 0 0
Gothenburg
Country [84] 0 0
Taiwan
State/province [84] 0 0
Taipei
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Oxford
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Clydebank
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Edinburgh
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Hull
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Leicester
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Liverpool
Country [91] 0 0
United Kingdom
State/province [91] 0 0
London
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Manchester
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Middlesbrough
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Sheffield
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Other
Name
Weill Medical College of Cornell University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
New York Presbyterian Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Sunnybrook Health Sciences Centre
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Cedars-Sinai Medical Center
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Columbia University
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Duke University
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mario Gaudino, Prof/PhD/MD
Address 0 0
Weill Medical College of Cornell University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Mario Gaudino, Prof/PhD/MD
Address 0 0
Country 0 0
Phone 0 0
212.746.1812
Fax 0 0
Email 0 0
mfg9004@med.cornell.edu
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Primary outcome data under request

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
From publication until the third year after publication
Available to whom?
Research scope
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04124120