About ROMA:WOMEN
Summary
ROMA:WOMEN is a prospective un-blinded randomized multicenter clinical trial. Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG). All patients will receive a single internal thoracic artery (ITA) to the left anterior descending coronary artery (LAD). In the Multiple Arterial Graft group, the major vessel to the lateral wall will be grafted with a radial artery or a second ITA. The primary outcome will be a composite of death from any cause, 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. The secondary outcome will be the impact of MAG vs SAG on generic and disease-specific Quality of Life (QOL), and physical and mental health symptoms in women undergoing CABG.
Principal Investigators
Mario F. L. Gaudino, MD
Principal Investigator
Department of Cardiothoracic Surgery, Weill Cornell Medicine
New York, NY, USA
Stephen Fremes, MD
Principal Investigator
Sunnybrook Health Science, University of Toronto
Toronto, ON, Canada
Noel Bairey Merz, MD
Principal Investigator
Info coming soon.
Ruth Masterson Creber, PhD
Principal Investigator
Info coming soon.
Investigators
| Name | Institution | Location |
|---|---|---|
| NameMario F. L. Gaudino MD, Principal Investigator | InstitutionDepartment of Cardiothoracic Surgery, Weill Cornell Medicine | LocationNew York, NY, USA |
| NameStephen Fremes MD, Principal Investigator | InstitutionSunnybrook Health Science, University of Toronto | LocationToronto, ON, Canada |
| NameC Noel Bairey Merz, MD, Principal Investigator | InstitutionSmidt Heart Institute | LocationLos Angeles, CA, USA |
| NameRuth Masterson Creber, Ph.D., Principal Investigaor' | InstitutionColumbia University | LocationColorado, USA |
| NameKarla Ballman, PhD | InstitutionWeill Cornell Medicine | LocationNew York, USA |
| NameSean O'Brien, PhD | InstitutionDuke University | LocationNorth Carolina, USA |
| NameAlistair Royse, M.D. | InstitutionThe University of Melbourne | LocationMelbourne, Australia |
| NameElfriede Ruttmann-Ulmer, M.D. | InstitutionInnsbruck (Medical University) Austria | LocationInnsbruck, Austria |
| NameSigrid Sandner, M.D. | InstitutionMU Vienna Austria | LocationAustria |
| NameHeinrich Mächler, M.D. | InstitutionMU Graz | LocationAustria |
| NameAndreas F. Zierer, M.D. | InstitutionKepler University Hospital | LocationAustria |
| NameSteven Meyer, M.D. | InstitutionMazankowski Alberta Heart Institute | LocationAlberta, Canada |
| NameDaniel Wong, M.D. | InstitutionFraser Clinical Trials | LocationBritish Columbia, Canada |
| NameNitin Ghorpade, M.D. | InstitutionSt. Boniface General Hospital / WHRA | LocationManitoba, Canada |
| NameAndre Lamy, M.D. | InstitutionHamilton General Hospital | LocationOntario, Canada |
| NameDavid Nagpal, M.D. | InstitutionLondon Health Sciences Ontario Canada | LocationOntario, Canada |
| NameMarc Ruel, M.D. | InstitutionU of Ottawa Heart Institute Canada | LocationOntario, Canada |
| NameHugues Jeanmart, M.D. | InstitutionHôpital Sacré-Cœur | LocationQuebec, Canada |
| NameMohamed Marzouk, M.D. | InstitutionUniversite Laval Quebec (CRIUCPQ) Canada - Institut Universitaire de cardiologie et de pneumologie de Québec | LocationQuebec, Canada |
| NameKevin Lachapelle, M.D. | InstitutionRoyal Victoria Hospital (McGill Univ Health Ctr) | LocationQuebec, Canada |
| NameJessica Forcillo, M.D. | InstitutionUniversity Hospital of Montreal (CHUM) | LocationQuebec, Canada |
| NamePhilippe Demers, M.D. | InstitutionMontreal Heart Institute | LocationQuebec, Canada |
| NameCraig Brown, M.D. | InstitutionHorizon Health Network - Saint John Regional Hospital (New Brunswick) | LocationNew Brunswick, Canada |
| NameMassimo Lemma, M.D. | InstitutionJilin Heart Hospital China | LocationJilin, China |
| NameZhe Zheng, M.D. | InstitutionFuwai Hospital China | LocationBeijing, China |
| NameQiang Zhao, M.D. | InstitutionRuijin Hospital Shanghai Jiao Tong University School of Medicine | LocationShanghai, China |
| NameIgor Rudez, M.D. | InstitutionUniversity Hospital Dubrava | LocationZagreb, Croatia |
| NameJan Vojacek, M.D. | InstitutionUniversity Hradec Králové | LocationHradec Králové, Czech Republic |
| NameMartin Czerny, M.D. | InstitutionUniversitäts-Herzzentrum Bad Krozingen/Freiburg | LocationBad Krozingen/Freiburg, Germany |
| NameAndreas Boening, M.D. | InstitutionUniversity Hospital of Giessen and Marburg | LocationGermany |
| NameMarcus-Andre Deutsch, M.D. | InstitutionHDZ NRW Bad Oeynhausen Germany | LocationBad Oeynhausen, Germany |
| NameMichael Borger, M.D. | InstitutionHeart Center (Herzzentrum) Leipzig Germany | LocationLeipzig, Germany |
| NameTerrence John Donovan, M.D. | InstitutionKrankenhaus der Barmherzigen Brüder Trier | LocationGermany |
| NameAlexander Assmann, M.D. | InstitutionDusseldorf University | LocationGermany |
| NameTorsten Doenst, M.D. | InstitutionJena University Hospital | LocationGermany |
| NameBernhard Danner, M.D. | InstitutionUniversity Medical Center of Goettingen | LocationGöttingen, Germany |
| NameStephan Jacobs, M.D. | InstitutionDeutsches Herzzentrum der Charité | LocationGermany |
| NameGopichand Mannam, M.D. Lokeswara Rao Sajja, M.D. | InstitutionStar Hospitals - Hyderabad, India | LocationIndia |
| NameChandra Padmanabhan, M.D. | InstitutionG Kuppuswamy Naidu Memorial Hospital (GKNM) | LocationIndia |
| NameRuggero De Paulis, M.D. | InstitutionEuropean Hospital, Roma, Italy | LocationRoma, Italy |
| NameGiuseppe Speziale, M.D. | InstitutionAnthea Hospital, Bari, Italy | LocationBari, Italy |
| NameMassimo Massetti, M.D. | InstitutionUniversita’ Cattolica del Sacro Cuore, Roma, Italy | LocationRoma, Italy |
| NameRoberto Lorusso, M.D. | InstitutionMUMC Maastricht (University Medical Centre) Netherlands | LocationMaastricht, Netherlands |
| NameAleksandar Nikolikj, M.D. | InstitutionAcibadem-Sistina Hospital | LocationNorth Macedonia |
| NameMark Deja, M.D. | InstitutionMedical University of Silesia, (Katowice) | LocationPoland |
| NameRomuald Cichon, M.D. | InstitutionZbigniew Religa Lower Silesian Heart Disease Centre - Medinet | LocationPoland |
| NameAndrzej Łoś, M.D | InstitutionMedical University Gdansk | LocationGdańsk, Poland |
| NameManuel Antunes, M.D. | InstitutionUniversity Hospital Coimbra Portugal | LocationCoimbra, Portugal |
| NameYuri Vechersky, M.D. | InstitutionNational Research Medical Center of the Russian Academy of Sciences - Tomsk, Russia | LocationTomsk, Russia |
| NameHo Young Hwang, M.D. | InstitutionSeoul National University Hospital | LocationSeolul, S. Korea |
| NameMilan Milojevic, M.D. | InstitutionDedinje Cardiovascular Institute | LocationBeograd, Serbia |
| NameJose Albors Martin, M.D. | InstitutionHospital Universitario del Vinalopo, Alicante, Spain (lead site in Spain) | LocationSpain |
| NameJorge Alcocer, M.D. | InstitutionHospital Clinic de Barcelona (ICCV) | LocationBarcelona, Spain |
| NameJavier De Diego Candela, M.D. | InstitutionNavarra Biomed | LocationNavarra, Spain |
| NamePaula Campelos, M.D. | InstitutionHospital Clinico de San Carlos | LocationMadrid, Spain |
| NameAnders Jeppsson, M.D. | InstitutionSahlgrenska University Hospital | LocationGothenburg, Sweden |
| NameJanice Kallonen, M.D. | InstitutionKaronlinska University Hospital | LocationSolna, Sweden |
| NameMahmoud Loubani, M.D. | InstitutionHull University Hospitals | LocationYorkshire, United Kingdom - England |
| NameMarjan Jahangiri, M.D. | InstitutionSt George's University Hospitals | LocationLondon, United Kingdom - England |
| NameMustafa Zakkar, M.D. | InstitutionUniversity Hospitals of Leicester | LocationLondon, United Kingdom - England |
| NameJessica Rove, M.D. | InstitutionUniversity of Colorado | LocationColorado, USA |
| NameDaniel Engelman, M.D. | InstitutionBaystate Health | LocationMassachussets, USA |
| NameCharles Mack, M.D. | InstitutionNew York Presbyterian Queens | LocationNew, York, USA |
| NameSandhya Balaram, M.D. | InstitutionNewYork-Presbyterian Brooklyn Methodist Hospital | LocationNew York, USA |
| NameBrittany Zwischenberger, M.D. | InstitutionDuke University | LocationNorth Carolina, USA |
| NameRoland Assi, M.D. | InstitutionYale University | LocationConnecticut, USA |
| NameJuan B. Grau, M.D. | InstitutionThe Valley Hospital | LocationNew Jersey, USA |
| NameKoji Takeda, M.D. | InstitutionColumbia University | LocationNew York, USA |
| NamePuja Kachroo, M.D. | InstitutionWashington University in St. Louis | LocationMissouri, USA |
| NameHasam Balkhy, M.D. | InstitutionUniversity of Chicago | LocationIllinois, USA |
| NameGianluca Torregrossa, M.D. | InstitutionLankenau Medical Center | LocationPennsylvania, USA |
| NameMolly Schultheis, M.D. | InstitutionEnglewood Health | LocationNew Jersey, USA |
| NameSara Pereira, M.D. | InstitutionUniversity of Utah | LocationUtah, USA |
| NameMarisa Cevasco, M.D. | InstitutionUniversity of Pennsylvania | LocationPennsylvania, USA |
| NameMichael DiMaio, M.D. | InstitutionBaylor Scott & White Research Institute | LocationTexas, USA |
| NameAbe DeAnda, M.D. | InstitutionThe University of Texas Medical Health Branch at Galveston | LocationTexas, USA |
| NameBenjamin Degner, M.D. | InstitutionEast Carolina University | LocationNorth Carolina, USA |
| NameArash Salemi, M.D. | InstitutionNewark Beth Israel Medical Center | LocationNew Jersey, USA |
| NameJoanna Chikwe, M.D. | InstitutionCedars-Sinai Medical Center | LocationCalifornia, USA |
| NameAfshin Efsan, M.D. | InstitutionRhode Island Hospital | LocationRhode Island, USA |
| NameJennifer Lawton, M.D. | InstitutionJohn Hopkins University | LocationMaryland, USA |
| NameAleem Siddique, M.D. | InstitutionUniversity of Nebraska Medical Center | LocationNebraska, USA |
| NameNirav Patel, M.D. | InstitutionNorthwell Health - North Shore Campus/Lenox Hill Hospital/ Staten Island/ Southside | LocationNew York, USA |
| NameJohn Bozinovski, M.D. | InstitutionOhio State University (OSU) | LocationOhio, USA |
| NameBindu Bittira, M.D. | InstitutionHealth Sciences North - Sudbury (HSN Sudbury) | LocationOntario, Canada |
| NameJanet Ngu, M.D. | InstitutionNL Health Services | LocationNewfoundland and Labrador, Canada |
| NameChristian Carranza, M.D. | InstitutionRigshospitalet | LocationDenmark |
| NameGennady Atroshchenko, M.D. | InstitutionAalborg University Hospital | LocationDenmark |
| NameEhab Noob, M.D. | InstitutionUniversity Hospital Erlangen | LocationGermany |
| NameMatthias Klaus Thielmann, M.D. | InstitutionEssen University | LocationGermany |
| NameAlfonso Agnino, M.D. | InstitutionHumanitas Gavazzeni of Bergamo | LocationItaly |
| NameMassimo Bonacchi, M.D. | InstitutionCareggi University Hospital | LocationItaly |
| NameRalph White, M.D. | InstitutionSouth Tees Hospitals NHS Trust | LocationUnited Kingdom |
| NameVipin Zamvar, M.D. | InstitutionRoyal Infirmary of Edinburgh | LocationUnited Kingdom |
| NameNnamdi Nwaejike, M.D. | InstitutionManchester University NHS Trust | LocationUnited Kingdom |
| NameAntonios Kourliouros, M.D. | InstitutionOxford University Hospitals NHS Trust | LocationUnited Kingdom |
| NameGuiseppe Rescigno, M.D. | InstitutionRoyal Wolverhampton NHS Trust | LocationUnited Kingdom |
| NameGovind Chetty, M.D. | InstitutionSheffield Teaching Hospitals NHS Foundation Trust | LocationUnited Kingdom |
| NameCesare Quarto, M.D. | InstitutionGuy's and St Thomas' NHS Foundation Trust | LocationUnited Kingdom |
| NameAl-Attar, Nawwar | InstitutionNHS Golden Jubilee | LocationUnited Kingdom |
| NameBil Kirmani, M.D. | InstitutionLiverpool Heart and Chest Hospital Foundation Trust | LocationUnited Kingdom |
| NamePrakash Punjabi, M.D. | InstitutionImperial College Healthcare NHS Trust | LocationUnited Kingdom |
| NameAlison Ward, M.D. | InstitutionEmory University | LocationGeorgia, USA |
| NameLauren Barron, M.D. | InstitutionBaylor College of Medicine | LocationTexas, USA |
| NameDawn Hui, M.D. | InstitutionUT Health San Antonio | LocationTexas, USA |
| NameLeora Balsam, M.D. | InstitutionUniversity of Massachusetts Chan Medical School | LocationMassachussets, USA |
| NameHelenMari Merritt-Genore, M.D. | InstitutionMethodists Physicians Health | LocationNebraska, USA |