Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women (ROMA:Women)
Heart Diseases, Coronary Artery Disease, Coronary Artery Bypass Grafting
About this trial
This is an interventional treatment trial for Heart Diseases
Eligibility Criteria
Inclusion Criteria:
- Women patients ≥18 years old.
- Isolated coronary artery bypass grafting.
- Primary (first time) 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.
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
Sites / Locations
- University of ColoradoRecruiting
- Baystate HealthRecruiting
- Nebraska Heart Hospital
- University of Nebraska Medical CenterRecruiting
- Weill Cornell MedicineRecruiting
- Icahn School of Medicine, Mount Sinai
- Lenox Hill Hospital
- Cleveland Clinic Foundation
- Ohio State UniversityRecruiting
- Allegheny General Hospital
- Medical University of GrazRecruiting
- Innsbruck Medical UniversityRecruiting
- Medical University of ViennaRecruiting
- Krankenhaus Nord Vienna North HospitalRecruiting
- Institute of Cardiology Porto Alegre
- Heart Institute University of São Paulo
- Instituto Dante Pazzanese de Cardiologia
- St. Boniface General HospitalRecruiting
- Horizon Health Network - Saint John Regional HospitalRecruiting
- Hamilton General HospitalRecruiting
- London Health SciencesRecruiting
- University of Ottawa Heart InstituteRecruiting
- Health Sciences North
- Sunnybrook Health SciencesRecruiting
- Toronto General Hospital
- Montreal Heart InstituteRecruiting
- University Hospital of MontrealRecruiting
- Royal Victoria HospitalRecruiting
- Institut Universitaire de Cardiologie et de Pneumologie de QuébecRecruiting
- Fuwai Hospital China
- Jilin Heart Hospital ChinaRecruiting
- Ruijin Hospital Shanghai Jiao Tong University School of MedicineRecruiting
- Teda Hospital Tianjin China
- University Hospital DubravaRecruiting
- University Hradec Králové
- General University Hospital, Prague
- Universitäts-Herzzentrum Bad Krozingen Freiburg
- HDZ NRW Bad Oeynhausen Germany
- Essen University
- Duisburg Heart Center
- Dusseldorf UniversityRecruiting
- University Hospital Erlangen
- Frankfurt University
- University Hospital of Giessen and MarburgRecruiting
- University Medical Center of Göttingen
- Jena University HospitalRecruiting
- Heart Center Herzzentrum, LeipzigRecruiting
- Robert-Bosch-Hospital Stuttgart Germany
- Krankenhaus der Barmherzigen Brüder TrierRecruiting
- G Kuppuswamy Naidu Memorial Hospital (GKNM)Recruiting
- Star Hospitals - Hyderabad, IndiaRecruiting
- Rambam Health Care CampusRecruiting
- Anthea HospitalRecruiting
- Fondazione Poliambulanza
- Maria Cecilia Hospital GVM
- European HospitalRecruiting
- Universita' Cattolica del Sacro CuoreRecruiting
- Ospedale Le Molinette, Torino
- Tokyo Medical and Dental University
- Saitama Medical University Japan
- Severance Cardiovascular Hospital, Yonsei University College of Medicine
- Maastricht University Medical CentreRecruiting
- Medical University of SilesiaRecruiting
- Zbigniew Religa Lower Silesian Heart Disease CentreRecruiting
- University Hospital CoimbraRecruiting
- Centro Hospitalar Lisboa Ocidental
- Centro Hospitalar e Universitário Sao João
- Dedinje Cardiovascular InstituteRecruiting
- National University of Singapore
- Hospital Universitario del VinalopoRecruiting
- Hospital Clinic de BarcelonaRecruiting
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Single Arterial Graft (SAG) group
Multiple Arterial Graft (MAG) 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.
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.