Actively Recruiting
Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women
Led by Weill Medical College of Cornell University · Updated on 2026-04-01
2300
Participants Needed
146
Research Sites
358 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
N
New York Presbyterian Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 grafting (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 grafting (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 2,300 women randomized 1:1 to MAG or SAG. 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.
CONDITIONS
Official Title
Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women patients 18 years old or older
- Undergoing isolated coronary artery bypass grafting
- First time (primary) cardiac surgery procedure
- 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
You will not qualify if you...
- Male gender
- Single graft procedure
- Emergency operation
- Heart attack within 72 hours before surgery
- Left ventricular ejection fraction less than 35%
- Any other cardiac or non-cardiac procedure planned
- Previous cardiac surgery
- Severe preoperative organ dysfunction such as dialysis, liver failure, or respiratory failure
- Cancer or other conditions reducing life expectancy to less than 5 years
- Unable to use the saphenous vein or both radial and right internal thoracic arteries
- Expected need for coronary thrombo-endarterectomy
- Planned hybrid revascularization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 146 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Pomona Valley Hospital Medical Center
Pomona, California, United States, 91767
Actively Recruiting
3
University of California, San Francisco
San Francisco, California, United States, 94118
Actively Recruiting
4
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Hartford Hospital
Hartford, Connecticut, United States, 06106
Actively Recruiting
6
Yale University Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
7
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
8
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
9
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
10
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
11
Johns Hopkins University
Baltimore, Maryland, United States, 21218
Actively Recruiting
12
Baystate Health
Springfield, Massachusetts, United States, 01199
Actively Recruiting
13
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States, 01655
Completed
14
University of Michigan
Ann Arbor, Michigan, United States, 48104
Actively Recruiting
15
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, United States, 48073
Actively Recruiting
16
Washington University in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
17
Nebraska Heart Hospital
Lincoln, Nebraska, United States, 68526
Not Yet Recruiting
18
Methodist Physicians Health
Omaha, Nebraska, United States, 68118
Actively Recruiting
19
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
20
Englewood Health
Englewood, New Jersey, United States, 07631
Actively Recruiting
21
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Actively Recruiting
22
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
Actively Recruiting
23
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States, 11215
Actively Recruiting
24
Weill Cornell Medicine
New York, New York, United States, 10021
Actively Recruiting
25
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
26
Lenox Hill Hospital
New York, New York, United States, 10075
Not Yet Recruiting
27
New York Presbyterian Queens
Queens, New York, United States, 11355
Actively Recruiting
28
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
29
East Carolina University
Greenville, North Carolina, United States, 27858
Actively Recruiting
30
Wake Forest University
Winston-Salem, North Carolina, United States, 27106
Actively Recruiting
31
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
32
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
33
Genesis Healthcare System
Zanesville, Ohio, United States, 43701
Actively Recruiting
34
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
35
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Not Yet Recruiting
36
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
Actively Recruiting
37
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
38
Baylor Scott & White Research Institute
Dallas, Texas, United States, 75204
Actively Recruiting
39
The University of Texas Medical Health Branch at Galveston
Galveston, Texas, United States, 77550
Actively Recruiting
40
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
41
UT Health San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
42
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
43
Victorian Heart Hospital
Clayton, Australia, 3168
Actively Recruiting
44
The University of Melbourne
Melbourne, Australia
Actively Recruiting
45
Medical University of Graz
Graz, Austria, 8010
Actively Recruiting
46
Innsbruck Medical University
Innsbruck, Austria, 6020
Actively Recruiting
47
Kepler University Hospital
Linz, Austria
Actively Recruiting
48
Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
49
Krankenhaus Nord Vienna North Hospital
Vienna, Austria, 1210
Actively Recruiting
50
Institute of Cardiology Porto Alegre
Porto Alegre, Brazil, 9062000
Not Yet Recruiting
51
Heart Institute University of São Paulo
São Paulo, Brazil, 05508
Actively Recruiting
52
Instituto Dante Pazzanese de Cardiologia
Vila Mariana, Brazil, 04012-909
Not Yet Recruiting
53
Mazankowski Alberta Heart Institute
Edmonton, Alberta, Canada
Actively Recruiting
54
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Actively Recruiting
55
Horizon Health Network - Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Actively Recruiting
56
Newfoundland and Labrador Health Services
St. John's, Newfoundland and Labrador, Canada, A1B 3R4
Actively Recruiting
57
Health Sciences North
Greater Sudbury, Ontario, Canada, P3E 5J1
Actively Recruiting
58
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Actively Recruiting
59
London Health Sciences
London, Ontario, Canada, N6A 5A5
Actively Recruiting
60
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Actively Recruiting
61
Sunnybrook Health Sciences
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
62
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Not Yet Recruiting
63
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Actively Recruiting
64
University Hospital of Montreal
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
65
Royal Victoria Hospital
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
66
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Ste Foy, Quebec, Canada, G1V 4G5
Actively Recruiting
67
Hopital Sacre-Coeur
Montreal, Canada
Actively Recruiting
68
Fraser Clinical Trials
New Westminster, Canada
Actively Recruiting
69
Fuwai Hospital China
Beijing, Beijing Municipality, China, 100037
Completed
70
Jilin Heart Hospital China
Changchun, Jilin, China, 130052
Completed
71
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Completed
72
Teda Hospital Tianjin China
Tianjin, Tianjin Municipality, China, 300456
Completed
73
University Hospital Dubrava
Zagreb, Croatia, 10000
Actively Recruiting
74
University Hradec Králové
Hradec Králové, Czechia, 500 03
Actively Recruiting
75
General University Hospital, Prague
New Town, Czechia, 128 08
Not Yet Recruiting
76
Aalborg University Hospital
Aalborg, Denmark, 9000
Actively Recruiting
77
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
78
Universitäts-Herzzentrum Bad Krozingen Freiburg
Bad Krozingen, Baden-Wurttemberg, Germany, 79189
Actively Recruiting
79
HDZ NRW Bad Oeynhausen Germany
Bad Oeynhausen, Germany, 32545
Actively Recruiting
80
Deutsches Herzzentrum der Charite
Berlin, Germany
Actively Recruiting
81
Duisburg Heart Center
Duisburg, Germany, 47137
Not Yet Recruiting
82
Dusseldorf University
Düsseldorf, Germany, 40225
Actively Recruiting
83
University Hospital Erlangen
Erlangen, Germany, 91054
Completed
84
Essen University
Essen, Germany, 45147
Actively Recruiting
85
Frankfurt University
Frankfurt, Germany, 60323
Not Yet Recruiting
86
University Hospital of Giessen and Marburg
Giessen, Germany, 35385
Actively Recruiting
87
University Medical Center of Göttingen
Göttingen, Germany, 37075
Actively Recruiting
88
Heidelberg University
Heidelberg, Germany
Actively Recruiting
89
Jena University Hospital
Jena, Germany, 07743
Actively Recruiting
90
Heart Center Herzzentrum, Leipzig
Leipzig, Germany, 04289
Actively Recruiting
91
TUM University Hospital German Heart Center
Munich, Germany
Actively Recruiting
92
Robert-Bosch-Hospital Stuttgart Germany
Stuttgart, Germany, 70376
Not Yet Recruiting
93
Krankenhaus der Barmherzigen Brüder Trier
Trier, Germany, 54292
Actively Recruiting
94
G Kuppuswamy Naidu Memorial Hospital (GKNM)
Coimbatore, Tamil Nadu, India, 641037
Completed
95
Star Hospitals - Hyderabad, India
Hyderabad, Telangana, India, 500034
Completed
96
Rambam Health Care Campus
Haifa, Israel, 3109601
Completed
97
Anthea Hospital
Bari, Italy, 70124
Actively Recruiting
98
Humanitas Gavazzeni of Bergamo
Bergamo, Italy, 24125
Actively Recruiting
99
Fondazione Poliambulanza
Brescia, Italy, 25124
Not Yet Recruiting
100
Maria Cecilia Hospital GVM
Cotignola, Italy, 48033
Not Yet Recruiting
101
Careggi University Hospital
Florence, Italy, 50134
Actively Recruiting
102
European Hospital
Roma, Italy, 00149
Actively Recruiting
103
Universita' Cattolica del Sacro Cuore
Roma, Italy, 00168
Actively Recruiting
104
Ospedale Le Molinette, Torino
Torino, Italy, 10126
Not Yet Recruiting
105
Tokyo Medical and Dental University
Bunkyō-Ku, Tokyo, Japan, 113-8510
Not Yet Recruiting
106
Saitama Medical University Japan
Saitama, Japan, 350-0451
Not Yet Recruiting
107
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333
Actively Recruiting
108
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015
Actively Recruiting
109
Maastricht University Medical Centre
Maastricht, Netherlands, 6229
Actively Recruiting
110
Acibadem-Sistina Hospital
Skopje, North Macedonia
Actively Recruiting
111
Medical University Gdansk
Gdansk, Poland, 80-210
Actively Recruiting
112
Medical University of Silesia
Katowice, Poland, 40-055
Actively Recruiting
113
Zbigniew Religa Lower Silesian Heart Disease Centre
Zabrze, Poland, 41-800
Actively Recruiting
114
University Hospital Coimbra
Coimbra, Portugal, 3004-561
Actively Recruiting
115
Centro Hospitalar Lisboa Ocidental
Lisbon, Portugal, 1300-598
Not Yet Recruiting
116
Centro Hospitalar e Universitário Sao Joao
Porto, Portugal, 4200-072
Actively Recruiting
117
National Research Medical Center of the Russian Academy of Sciences - Tomsk, Russia
Tomsk, Russia
Completed
118
Dedinje Cardiovascular Institute
Belgrade, Serbia, 11000
Actively Recruiting
119
National University of Singapore
Singapore, Singapore, 119077
Not Yet Recruiting
120
Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, South Korea, 03722
Not Yet Recruiting
121
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
122
Hospital Universitario del Vinalopo
Elche, Alicante, Spain, 03293
Actively Recruiting
123
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
124
Hospital Clinico de San Carlos
Madrid, Spain
Actively Recruiting
125
NavarraBiomed
Pamplona, Spain
Actively Recruiting
126
Sahlgrenska University Hospital
Gothenburg, Sweden
Actively Recruiting
127
Karonlinska University Hospital
Stockholm, Sweden, 171 76
Actively Recruiting
128
National Taiwan University Hospital
Zhongzheng, Taipei, Taiwan, 100229
Not Yet Recruiting
129
Blackpool Teaching Hospitals NHS Trust
Blackpool, Lancashire, United Kingdom, FY3 8NR
Actively Recruiting
130
Oxford University Hospitals NHS Trust
Multiple Locations, Oxford, United Kingdom
Actively Recruiting
131
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
Actively Recruiting
132
Royal Papworth NHS Foundation Trust
Cambridge, United Kingdom, CB2 0A
Actively Recruiting
133
NHS Golden Jubilee
Clydebank, United Kingdom, G81 4DY
Actively Recruiting
134
The Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH16 4SA
Actively Recruiting
135
Hull University Hospitals
Hull, United Kingdom
Actively Recruiting
136
University Hospitals of Leicester
Leicester, United Kingdom
Actively Recruiting
137
Liverpool Heart and Chest Hospital Foundation Trust
Liverpool, United Kingdom, L14 3PE
Actively Recruiting
138
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH
Actively Recruiting
139
Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1NY
Actively Recruiting
140
Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital
London, United Kingdom
Actively Recruiting
141
St George's University Hospitals
London, United Kingdom
Actively Recruiting
142
Manchester University NHS Trust
Manchester, United Kingdom, M13 9WL
Actively Recruiting
143
South Tees Hospitals NHS Trust
Middlesbrough, United Kingdom, TS4 3BW
Actively Recruiting
144
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom, S10 2SB
Actively Recruiting
145
Mid and South Essex NHS Foundation Trust
Westcliff-on-Sea, United Kingdom
Actively Recruiting
146
Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom, WV10 0QP
Actively Recruiting
Research Team
M
Mario Gaudino, Prof/PhD/MD
CONTACT
S
Stephen Fremes, Prof/MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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