Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

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/ct2/show/NCT04124120




Registration number
NCT04124120
Ethics application status
Date submitted
10/10/2019
Date registered
11/10/2019
Date last updated
20/12/2023

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
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Nebraska
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Rhode Island
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Utah
Country [17] 0 0
Austria
State/province [17] 0 0
Graz
Country [18] 0 0
Austria
State/province [18] 0 0
Innsbruck
Country [19] 0 0
Austria
State/province [19] 0 0
Linz
Country [20] 0 0
Austria
State/province [20] 0 0
Vienna
Country [21] 0 0
Brazil
State/province [21] 0 0
Porto Alegre
Country [22] 0 0
Brazil
State/province [22] 0 0
São Paulo
Country [23] 0 0
Brazil
State/province [23] 0 0
Vila Mariana
Country [24] 0 0
Canada
State/province [24] 0 0
Manitoba
Country [25] 0 0
Canada
State/province [25] 0 0
New Brunswick
Country [26] 0 0
Canada
State/province [26] 0 0
Ontario
Country [27] 0 0
Canada
State/province [27] 0 0
Quebec
Country [28] 0 0
Canada
State/province [28] 0 0
Montréal
Country [29] 0 0
Canada
State/province [29] 0 0
New Westminster
Country [30] 0 0
China
State/province [30] 0 0
Beijing
Country [31] 0 0
China
State/province [31] 0 0
Jilin
Country [32] 0 0
China
State/province [32] 0 0
Shanghai
Country [33] 0 0
China
State/province [33] 0 0
Tianjin
Country [34] 0 0
Croatia
State/province [34] 0 0
Zagreb
Country [35] 0 0
Czechia
State/province [35] 0 0
Hradec Králové
Country [36] 0 0
Czechia
State/province [36] 0 0
Nové Mesto
Country [37] 0 0
Germany
State/province [37] 0 0
Baden-Wuerttemberg
Country [38] 0 0
Germany
State/province [38] 0 0
Bad Oeynhausen
Country [39] 0 0
Germany
State/province [39] 0 0
Berlin
Country [40] 0 0
Germany
State/province [40] 0 0
Duisburg
Country [41] 0 0
Germany
State/province [41] 0 0
Düsseldorf
Country [42] 0 0
Germany
State/province [42] 0 0
Erlangen
Country [43] 0 0
Germany
State/province [43] 0 0
Frankfurt
Country [44] 0 0
Germany
State/province [44] 0 0
Gießen
Country [45] 0 0
Germany
State/province [45] 0 0
Göttingen
Country [46] 0 0
Germany
State/province [46] 0 0
Jena
Country [47] 0 0
Germany
State/province [47] 0 0
Leipzig
Country [48] 0 0
Germany
State/province [48] 0 0
Stuttgart
Country [49] 0 0
Germany
State/province [49] 0 0
Trier
Country [50] 0 0
India
State/province [50] 0 0
Tamil Nadu
Country [51] 0 0
India
State/province [51] 0 0
Telangana
Country [52] 0 0
Israel
State/province [52] 0 0
Haifa
Country [53] 0 0
Italy
State/province [53] 0 0
Bari
Country [54] 0 0
Italy
State/province [54] 0 0
Brescia
Country [55] 0 0
Italy
State/province [55] 0 0
Cotignola
Country [56] 0 0
Italy
State/province [56] 0 0
Roma
Country [57] 0 0
Italy
State/province [57] 0 0
Torino
Country [58] 0 0
Japan
State/province [58] 0 0
Tokyo
Country [59] 0 0
Japan
State/province [59] 0 0
Saitama
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Seoul
Country [61] 0 0
Korea, Republic of
State/province [61] 0 0
Seúl
Country [62] 0 0
Netherlands
State/province [62] 0 0
Maastricht
Country [63] 0 0
North Macedonia
State/province [63] 0 0
Skopje
Country [64] 0 0
Poland
State/province [64] 0 0
Katowice
Country [65] 0 0
Poland
State/province [65] 0 0
Zabrze
Country [66] 0 0
Portugal
State/province [66] 0 0
Coimbra
Country [67] 0 0
Portugal
State/province [67] 0 0
Lisboa
Country [68] 0 0
Portugal
State/province [68] 0 0
Porto
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Tomsk
Country [70] 0 0
Serbia
State/province [70] 0 0
Belgrade
Country [71] 0 0
Singapore
State/province [71] 0 0
Singapore
Country [72] 0 0
Spain
State/province [72] 0 0
Alicante
Country [73] 0 0
Spain
State/province [73] 0 0
Barcelona
Country [74] 0 0
Spain
State/province [74] 0 0
Madrid
Country [75] 0 0
Spain
State/province [75] 0 0
Pamplona
Country [76] 0 0
Sweden
State/province [76] 0 0
Gothenburg
Country [77] 0 0
Taiwan
State/province [77] 0 0
Taipei
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Hull
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Leicester
Country [80] 0 0
United Kingdom
State/province [80] 0 0
London

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
The central hypothesis of ROMA:Women is that the use of multiple arterial grafting (MAG) will
improve clinical outcomes and quality of life (QOL) compared to single arterial grfating
(SAG).

The specific aims of ROMA:Women are:

Aim 1: Determine the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events
in women undergoing coronary artery bypass grfating (CABG). The investigators will compare
major adverse cardiac and cerebrovascular events (death, stroke, non-procedural myocardial
infarction, repeat revascularization, and hospital readmission for acute coronary syndrome or
heart failure) in a cohort of 2,000 women randomized 1:1 to MAG or SAG (690 from the parent
ROMA trial + 1,310 from ROMA:Women). Differences by important clinical and surgical subgroups
(patients younger or older than 70 years, diabetics, racial and ethnic minorities, on vs off
pump CABG, type of arterial grafts used) will also be evaluated. The women enrolled in the
ongoing ROMA trial (anticipated to be approximately 690) will be included in ROMA:Women,
increasing efficiency and reducing enrollment time.

Hypothesis 1.0. MAG will reduce the incidence of major adverse cardiac and cerebrovascular
events.

Hypothesis 1.1. The improvement with MAG will be consistent across key subgroups.

Aim 2: Determine the impact of MAG vs SAG on generic and disease-specific QOL, physical and
mental health symptoms in women undergoing CABG. The investigators will compare generic
(SF-12, EQ-5D) and disease-specific (Seattle Angina Questionnaire) QOL and physical and
mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG
(including those enrolled in ROMA:QOL). Differences by important subgroups (as defined above)
will also be evaluated.

Hypothesis 2.0. MAG will improve generic and disease-specific QOL compared to SAG.

Hypothesis 2.1. MAG will improve physical and mental health symptoms compared to SAG.

Hypothesis 2.2. The improvement with MAG will be consistent across key subgroups.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04124120
Trial related presentations / publications
Loop FD, Lytle BW, Cosgrove DM, Stewart RW, Goormastic M, Williams GW, Golding LA, Gill CC, Taylor PC, Sheldon WC, et al. Influence of the internal-mammary-artery graft on 10-year survival and other cardiac events. N Engl J Med. 1986 Jan 2;314(1):1-6. doi: 10.1056/NEJM198601023140101.
Tatoulis J, Buxton BF, Fuller JA. Patencies of 2127 arterial to coronary conduits over 15 years. Ann Thorac Surg. 2004 Jan;77(1):93-101. doi: 10.1016/s0003-4975(03)01331-6.
Lytle BW, Blackstone EH, Loop FD, Houghtaling PL, Arnold JH, Akhrass R, McCarthy PM, Cosgrove DM. Two internal thoracic artery grafts are better than one. J Thorac Cardiovasc Surg. 1999 May;117(5):855-72. doi: 10.1016/S0022-5223(99)70365-X.
Taggart DP, D'Amico R, Altman DG. Effect of arterial revascularisation on survival: a systematic review of studies comparing bilateral and single internal mammary arteries. Lancet. 2001 Sep 15;358(9285):870-5. doi: 10.1016/S0140-6736(01)06069-X.
Yi G, Shine B, Rehman SM, Altman DG, Taggart DP. Effect of bilateral internal mammary artery grafts on long-term survival: a meta-analysis approach. Circulation. 2014 Aug 12;130(7):539-45. doi: 10.1161/CIRCULATIONAHA.113.004255. Epub 2014 Jun 10.
Hillis LD, Smith PK, Anderson JL, Bittl JA, Bridges CR, Byrne JG, Cigarroa JE, Disesa VJ, Hiratzka LF, Hutter AM Jr, Jessen ME, Keeley EC, Lahey SJ, Lange RA, London MJ, Mack MJ, Patel MR, Puskas JD, Sabik JF, Selnes O, Shahian DM, Trost JC, Winniford MD; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; Society of Cardiovascular Anesthesiologists; Society of Thoracic Surgeons. 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Developed in collaboration with the American Association for Thoracic Surgery, Society of Cardiovascular Anesthesiologists, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2011 Dec 6;58(24):e123-210. doi: 10.1016/j.jacc.2011.08.009. Epub 2011 Nov 7. No abstract available.
Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.
Aldea GS, Bakaeen FG, Pal J, Fremes S, Head SJ, Sabik J, Rosengart T, Kappetein AP, Thourani VH, Firestone S, Mitchell JD; Society of Thoracic Surgeons. The Society of Thoracic Surgeons Clinical Practice Guidelines on Arterial Conduits for Coronary Artery Bypass Grafting. Ann Thorac Surg. 2016 Feb;101(2):801-9. doi: 10.1016/j.athoracsur.2015.09.100. Epub 2015 Dec 8.
Benedetto U, Raja SG, Albanese A, Amrani M, Biondi-Zoccai G, Frati G. Searching for the second best graft for coronary artery bypass surgery: a network meta-analysis of randomized controlled trialsdagger. Eur J Cardiothorac Surg. 2015 Jan;47(1):59-65; discussion 65. doi: 10.1093/ejcts/ezu111. Epub 2014 Mar 30.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04124120