At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Single arterial graft (procedure), Multiple arterial grafting (procedure)
- How long the study runs
- Study runs about 83 months (dates as stated)
- About the drug or intervention
- Single arterial graft — procedure: This interventions consists of patients receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. · Multiple arterial grafting — procedure: This intervention consists of the patient receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at heart surgery for women with coronary artery disease (narrowing of the heart's blood vessels). It compares outcomes when surgeons use one artery graft versus multiple artery grafts during coronary artery bypass grafting (surgery to improve blood flow to the heart). The study is sponsored by Weill Medical College of Cornell University.
Who can take part
- Women aged 18 or over
- Having coronary artery bypass grafting on its own, as a first-time heart operation
- Significant disease of the left main coronary artery, or of the left anterior descending and circumflex coronary arteries, with or without disease of the right coronary artery
Who may not be able to
- Men
- Having only a single graft
- Emergency surgery
- A heart attack within 72 hours before surgery
- A left ventricular ejection fraction (heart pumping strength) below 35%
- Any other heart or non-heart procedure at the same time
- Previous heart surgery
- Severe organ problems before surgery (such as dialysis, liver failure or respiratory failure), cancer, or any other illness that reduces life expectancy to less than 5 years
- Unable to use the saphenous vein (leg vein) or both the radial and right internal thoracic arteries
- Expected need for coronary thrombo-endarterectomy (removal of clots and plaque from an artery)
- Planned hybrid revascularisation (a mix of surgery and other treatments)
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Female
- Number of participants
- 2,300
- Started
- 2023-04-17
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for heart diseases
- • NA - 2,300 participants
- • 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)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with heart diseases
- • Female only
Where?
- • Blackpool - Blackpool Teaching Hospitals NHS Trust
- • Multiple Locations - Oxford University Hospitals NHS Trust
- • Stoke-on-Trent - University Hospitals of North Midlands NHS Trust
- • Cambridge - Royal Papworth NHS Foundation Trust
- • +14 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
ROMA:Women will leverage the infrastructure and the existing women population of the ROMA trial. ROMA:Women has two key Aims. In Aim 1, 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. In Aim 2, 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. Differences by important 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. ROMA:Women is a two-arm, international, multi-center, randomized clinical trial nested in the ROMA trial. ROMA:Women will include all the women enrolled in the parent ROMA trial and will leverage the existing ROMA infrastructure including clinical trial unit, database, case report forms (CRF), randomization system, site training resources, informed consent forms (ICF), regulatory approvals, Central Events Review Committee (CEC) processes/personnel, network of participating sites, site PIs, and study coordinators. The planned randomization procedure, interventions and treatment arms, outcome assessments and follow-up protocol of ROMA:Women are identical to those of the currently ongoing parent ROMA trial. The sites participating in ROMA will continue enrollment of women after the completion of the ROMA trial and additional sites will also be opened to reach the target sample size of ROMA:Women.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Female only
What the study is looking for
- ✓Women patients ≥18 years old.
- ✓Isolated coronary artery bypass grafting.
- ✓Primary (first time) heart surgery procedure.
- ✓Significant disease of the left main coronary artery or of the left anterior descending and the circumflex coronary...
Who cannot take part
- ✗Male gender
- ✗Single graft
- ✗Emergency operation
- ✗Myocardial infarction within 72 hours of surgery
- ✗Left ventricular ejection fraction \< 35%
See the full criteria
Where Is This Study? (18 UK sites)
Blackpool Teaching Hospitals NHS Trust
Blackpool FY3 8NR, United Kingdom
Oxford University Hospitals NHS Trust
Multiple Locations, United Kingdom
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent ST4 6QG, United Kingdom
Royal Papworth NHS Foundation Trust
Cambridge CB2 0A, United Kingdom
NHS Golden Jubilee
Clydebank G81 4DY, United Kingdom
The Royal Infirmary of Edinburgh
Edinburgh EH16 4SA, United Kingdom
Hull University Hospitals
Hull, United Kingdom
James Illingworth
hyp-tr.development.research@nhs.net01482 461883 or 461903University Hospitals of Leicester
Leicester, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351Liverpool Heart and Chest Hospital Foundation Trust
Liverpool L14 3PE, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London SE1 7EH, United Kingdom
Imperial College Healthcare NHS Trust
London W2 1NY, United Kingdom
Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital
London, United Kingdom
St George's University Hospitals
London, United Kingdom
Manchester University NHS Trust
Manchester M13 9WL, United Kingdom
South Tees Hospitals NHS Trust
Middlesbrough TS4 3BW, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield S10 2SB, United Kingdom
Mid and South Essex NHS Foundation Trust
Westcliff-on-Sea, United Kingdom
Royal Wolverhampton NHS Trust
Wolverhampton WV10 0QP, United Kingdom
How to Get in Touch
Mario Gaudino, Prof/PhD/MD
Sponsor contactCONTACT
Stephen Fremes, Prof/MD
Sponsor contactCONTACT