Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women

RECRUITING

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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.

Conditions:

🦠 Heart Diseases 🦠 Coronary Artery Disease 🦠 Coronary Artery Bypass Grafting

🗓️ Study Start (Actual) 17 April 2023

🗓️ Primary Completion (Estimated) March 2030

✅ Study Completion (Estimated) March 2030

👥 Enrollment (Estimated) 2000

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Los Angeles, California, United States

📍 Aurora, Colorado, United States

📍 New Haven, Connecticut, United States

📍 Chicago, Illinois, United States

📍 Baltimore, Maryland, United States

📍 Springfield, Massachusetts, United States

📍 Saint Louis, Missouri, United States

📍 Lincoln, Nebraska, United States

📍 Omaha, Nebraska, United States

📍 Englewood, New Jersey, United States

📍 Newark, New Jersey, United States

📍 Ridgewood, New Jersey, United States

📍 Brooklyn, New York, United States

📍 New York, New York, United States

📍 Queens, New York, United States

📍 Durham, North Carolina, United States

📍 Cleveland, Ohio, United States

📍 Columbus, Ohio, United States

📍 Philadelphia, Pennsylvania, United States

📍 Pittsburgh, Pennsylvania, United States

📍 Wynnewood, Pennsylvania, United States

📍 Providence, Rhode Island, United States

📍 Dallas, Texas, United States

📍 Salt Lake City, Utah, United States

📍 Melbourne, Australia

📍 Graz, Austria

📍 Innsbruck, Austria

📍 Linz, Austria

📍 Vienna, Austria

📍 Porto Alegre, Brazil

📍 São Paulo, Brazil

📍 Vila Mariana, Brazil

📍 Winnipeg, Manitoba, Canada

📍 Saint John, New Brunswick, Canada

📍 Hamilton, Ontario, Canada

📍 London, Ontario, Canada

📍 Ottawa, Ontario, Canada

📍 Sudbury, Ontario, Canada

📍 Toronto, Ontario, Canada

📍 Montréal, Quebec, Canada

📍 Ste Foy, Quebec, Canada

📍 Montréal, Canada

📍 New Westminster, Canada

📍 Beijing, Beijing, China

📍 Changchun, Jilin, China

📍 Shanghai, Shanghai, China

📍 Tianjin, Tianjin, China

📍 Zagreb, Croatia

📍 Hradec Králové, Czechia

📍 Nové Město, Czechia

📍 Bad Krozingen, Baden-Wuerttemberg, Germany

📍 Bad Oeynhausen, Germany

📍 Berlin, Germany

📍 Duisburg, Germany

📍 Düsseldorf, Germany

📍 Erlangen, Germany

📍 Frankfurt, Germany

📍 Gießen, Germany

📍 Göttingen, Germany

📍 Jena, Germany

📍 Leipzig, Germany

📍 Stuttgart, Germany

📍 Trier, Germany

📍 Coimbatore, Tamil Nadu, India

📍 Hyderabad, Telangana, India

📍 Haifa, Israel

📍 Bari, Italy

📍 Brescia, Italy

📍 Cotignola, Italy

📍 Roma, Italy

📍 Torino, Italy

📍 Bunkyō-Ku, Tokyo, Japan

📍 Saitama, Japan

📍 Seoul, Korea, Republic of

📍 Seúl, Korea, Republic of

📍 Maastricht, Netherlands

📍 Skopje, North Macedonia

📍 Katowice, Poland

📍 Zabrze, Poland

📍 Coimbra, Portugal

📍 Lisboa, Portugal

📍 Porto, Portugal

📍 Tomsk, Russian Federation

📍 Belgrade, Serbia

📍 Singapore, Singapore

📍 Elx, Alicante, Spain

📍 Barcelona, Spain

📍 Madrid, Spain

📍 Pamplona, Spain

📍 Gothenburg, Sweden

📍 Zhongzheng, Taipei, Taiwan

📍 Hull, United Kingdom

📍 Leicester, United Kingdom

📍 London, United Kingdom

More locations available...

📋 Eligibility Criteria

Description

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.

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

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: FEMALE

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 10 October 2019
First Submitted that Met QC Criteria 10 October 2019
First Posted 11 October 2019

Study Record Updates

Last Update Submitted that Met QC Criteria 19 December 2023
Last Update Posted 20 December 2023
Last Verified December 2023