[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100372032":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":67,"studyPopulation":61,"armGroups":68,"interventions":80,"overallOfficials":90,"centralContacts":108,"locations":117,"responsibleParty":1851,"collaborators":1853,"id":1860,"slug":1861,"hasResults":1862,"nctId":1863,"briefTitle":1864,"officialTitle":1865,"acronym":1866,"eligibilityCriteria":1867,"healthyVolunteers":1862,"sex":1868,"minAge":1869,"maxAge":61,"enrollmentInfo":1870,"targetDuration":61,"studyType":1873,"phases":1874,"briefSummary":1876,"conditions":1877,"keywords":61,"overallStatus":120,"whyStopped":61,"lastUpdateSubmitDate":1881,"lastUpdatePostDateStruct":1882,"startDateStruct":1885,"completionDateStruct":1887,"leadSponsor":1889,"locationsCount":1890},{"fullName":5,"class":6},"Weill Medical College of Cornell University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":51},[9,13],{"measure":10,"description":11,"timeFrame":12},"Primary outcome for aim 1: Death from any cause, any stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.","The primary outcome for aim 1 will be a composite of the first occurrence of death from any cause, any stroke, non-procedural myocardial infarction (\\>48 hours after surgery), repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.","Postoperatively, minimum 2.5 year follow-up",{"measure":14,"description":15,"timeFrame":12},"Primary outcome for aim 2: Disease-specific quality of life","Assessed using the Seattle Angina Questionnaire (SAQ), a validated 19-item questionnaire that measures five domains related to coronary disease: angina frequency, physical limitations, quality of life, angina stability, and treatment satisfaction. Scores range from 0 to 100 with higher scores indicating fewer symptoms and better health status. The minimum clinically important difference on the SAQ is 5 points.\n\nThe primary endpoint for aim 2 is the absolute change in the Seattle Angina Questionnaire (SAQ) at 12 months compared to baseline.",[17,20,23,26,29,33,36,39,42,45,48],{"measure":18,"description":19,"timeFrame":12},"Death from any cause, any stroke, non-procedural myocardial infarction, and repeat revascularization.","One of the secondary outcomes for aim 1: It will be a composite of the first occurrence of death from any cause, any stroke, non-procedural myocardial infarction (\\>48 hours after surgery), and repeat revascularization.\n\nThis is the primary outcome of the parent ROMA trial.",{"measure":21,"description":22,"timeFrame":12},"Death from cardiac cause, any stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.","Another secondary outcome for aim 1: It will be a composite of the first occurrence of death from cardiac cause, any stroke, non-procedural myocardial infarction (\\>48 hours after surgery), repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure.",{"measure":24,"description":25,"timeFrame":12},"Death from any cause","Another secondary outcome for aim 1: Death will be considered to be cardiac unless a definite non-cardiac cause is identified.",{"measure":27,"description":28,"timeFrame":12},"Stroke","Another secondary outcome for aim 1: Based on the American Heart Association\u002FAmerican Stroke Association Expert Consensus stroke definition, stroke will be identified in case of:\n\n1. pathological, imaging, or other objective evidence of cerebral ischemic injury in a defined vascular distribution; OR\n2. clinical evidence of cerebral ischemic injury based on symptoms persisting ≥24 hours or until death, and other etiologies excluded.",{"measure":30,"description":31,"timeFrame":32},"Non-procedural myocardial infarction","Another secondary outcome for aim 1: Based on the 4th Universal Definition, non-periprocedural myocardial infarction will be identified in case of detection of rise and\u002For fall of cardiac biomarkers with at least one value above the 99th percentile of the upper reference limit together with evidence of myocardial ischemia with at least one of the following:\n\n1. symptoms of ischemia\n2. electrocardiogram changes indicative of new ischemia (new ST-T changes or new left bundle branch block)\n3. development of pathological Q waves in the electrocardiogram\n4. imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.","> 48 hours postoperatively, minimum 2.5 year follow-up",{"measure":34,"description":35,"timeFrame":12},"Repeat revascularization","Another secondary outcome for aim 1: Repeat revascularization will include any percutaneous or surgical revascularization on a grafted coronary artery after the initial operation.",{"measure":37,"description":38,"timeFrame":12},"Readmission for acute coronary syndrome","Another secondary outcome for aim 1: Prolonged ischemic symptoms at rest (usually ≥10 minutes in duration), or accelerating pattern of chest pain that occurs with a lower activity threshold (CCS class III or IV) considered to be myocardial ischemia upon final diagnosis resulting in an unscheduled visit to a healthcare facility resulting in an overnight stay generally within 24 hours of the most recent symptoms, cardiac biomarkers not meeting MI criteria, and ECG or angiographic evidence of ischemia.",{"measure":40,"description":41,"timeFrame":12},"Readmission for heart failure","Another secondary outcome for aim 1: While patients may have multiple simultaneous disease processes, for the outcome event of heart failure requiring hospitalization, the diagnosis of congestive heart failure would need to be the primary process. Heart failure (HF) requiring hospitalization is defined as an event that meets the following criteria:\n\ni. Requires hospitalization AND ii. Clinical symptoms of heart failure AND iii. Physical signs of heart failure AND iv. Need for additional\u002Fincreased therapy AND v. No other non-cardiac etiology (such as chronic obstructive pulmonary disease, hepatic cirrhosis, acute renal failure, or venous insufficiency) and no other cardiac etiology (such as pulmonary embolus, cor pulmonale, primary pulmonary hypertension, or congenital heart disease) for signs or symptoms are identified.",{"measure":43,"description":44,"timeFrame":12},"Generic quality of life according to the Short Form Health Survey (SF-12v2)","Secondary outcomes for aim 2: The SF-12v12 measures eight dimensions of health: physical functioning, role limitations due to physical problems, bodily pain, vitality, general health perception, social function, role limitations due to emotional problems, and mental health. Scores for each domain range from 0 to 100 with higher scores indicating better health status.\n\nThe SF-12v2 has two summary measures: physical and mental self-perceived health with norm-based methods that standardize the score to a mean of 50 and standard deviation of 10.",{"measure":46,"description":47,"timeFrame":12},"Generic quality of life according to EuroQuol-5D (EQ-5D)","Secondary outcomes for aim 2: EQ-5D is a five-item instrument to assess health status in the following five dimensions: mobility, self-care, usual activity, pain or discomfort, and anxiety or depression. Individual domain scores will be converted to a summary index representing utility weights, which allow conduct of cost-effectiveness analyses.",{"measure":49,"description":50,"timeFrame":12},"Mental and physical health symptoms according to PROMIS instruments","Secondary outcomes for aim 2: Physical and mental health symptoms and physical functioning will be measured with standardized PROMIS instruments, including: Pain interference, Neuropathic Pain, Fatigue, Sleep disturbance, Depression, Anxiety, and Physical Function. A mean of 50 and a standard deviation of 10 represent the general population in the US.",[52],{"measure":53,"description":54,"timeFrame":55},"Other recorded outcomes (safety endpoints)","30-day mortality and major postoperative complications (revision for bleeding, perioperative MI (\\\u003C48 hours after surgery), need for dialysis, need for tracheostomy, and surgical site complications).","Within 30 days of surgery or during index hospitalization, whichever is longer.",{"allocation":57,"interventionModel":58,"interventionModelDescription":59,"primaryPurpose":60,"observationalModel":61,"timePerspective":61,"maskingInfo":62},"RANDOMIZED","PARALLEL","Patients undergoing coronary artery bypass surgery will be in one of two groups. One group will receive a single arterial graft and the second group will receive two or more arterial grafts.","TREATMENT",null,{"masking":63,"maskingDescription":64,"whoMasked":65},"SINGLE","The endpoint assessors will be blinded to treatment allocation (PROBE).",[66],"OUTCOMES_ASSESSOR","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.\n\nROMA: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\u002Fpersonnel, 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.",[69,75],{"label":70,"type":71,"description":72,"interventionNames":73},"Single Arterial Graft (SAG) group","EXPERIMENTAL","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.",[74],"Procedure: Single arterial graft",{"label":76,"type":71,"description":77,"interventionNames":78},"Multiple Arterial Graft (MAG) group","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.",[79],"Procedure: Multiple arterial grafting",[81,86],{"type":82,"name":83,"description":84,"armGroupLabels":85,"otherNames":61},"PROCEDURE","Single arterial graft","This interventions consists of patients receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. In addition to the left internal thoracic artery patients will receive venous grafts for all additional grafting.",[70],{"type":82,"name":87,"description":88,"armGroupLabels":89,"otherNames":61},"Multiple arterial grafting","This intervention consists of the patient receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. The second arterial graft (right internal thoracic artery or radial artery) will be directed to the major branch of the circumflex. Additional grafts will include saphenous veins or arterial conduits.",[76],[91,94,97,100,103,105],{"name":92,"affiliation":5,"role":93},"Mario Gaudino, Prof\u002FPhD\u002FMD","PRINCIPAL_INVESTIGATOR",{"name":95,"affiliation":96,"role":93},"Stephen Fremes, MD","Sunnybrook Health Sciences Centre",{"name":98,"affiliation":99,"role":93},"Ruth Masterson Creber, RN, PhD","Columbia University",{"name":101,"affiliation":102,"role":93},"C. Noel Bairey Merz, MD","Cedars-Sinai",{"name":104,"affiliation":5,"role":93},"Karla Ballman, PhD",{"name":106,"affiliation":107,"role":93},"Sean O'Brien, PhD","Duke University",[109,113],{"name":92,"role":110,"phone":111,"phoneExt":61,"email":112},"CONTACT","212.746.1812","mfg9004@med.cornell.edu",{"name":114,"role":110,"phone":115,"phoneExt":61,"email":116},"Stephen Fremes, Prof\u002FMD","1 416 480 6073","stephen.fremes@sunnybrook.ca",[118,135,147,159,172,185,197,210,223,236,249,262,275,285,298,310,323,337,349,358,371,383,395,408,419,428,437,449,461,473,485,498,510,522,535,547,559,572,585,597,609,621,634,648,659,673,685,696,708,717,731,743,755,769,782,795,808,821,833,845,857,869,878,891,900,909,916,924,935,947,957,967,977,991,1004,1016,1030,1042,1057,1069,1080,1092,1104,1113,1125,1137,1149,1161,1172,1184,1196,1207,1219,1231,1243,1253,1264,1278,1290,1302,1314,1326,1338,1347,1359,1369,1381,1396,1408,1420,1433,1447,1459,1471,1485,1497,1509,1519,1533,1546,1559,1567,1582,1594,1605,1616,1629,1641,1651,1666,1673,1686,1698,1710,1722,1733,1744,1756,1767,1776,1784,1792,1804,1816,1828,1839],{"facility":119,"status":120,"city":121,"state":122,"zip":123,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":131,"contacts":132},"Cedars-Sinai Medical Center","RECRUITING","Los Angeles","California","90048","United States","US",{"type":127,"coordinates":128},"Point",[129,130],-118.24368,34.05223,{"lat":130,"lon":129},[133],{"name":134,"role":110,"phone":61,"phoneExt":61,"email":61},"Joanna Chikwe, MD",{"facility":136,"status":120,"city":137,"state":122,"zip":138,"country":124,"countryCode":125,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Pomona Valley Hospital Medical Center","Pomona","91767",{"type":127,"coordinates":140},[141,142],-117.75228,34.05529,{"lat":142,"lon":141},[145],{"name":146,"role":110,"phone":61,"phoneExt":61,"email":61},"Christine Montesa, MD",{"facility":148,"status":120,"city":149,"state":122,"zip":150,"country":124,"countryCode":125,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"University of California, San Francisco","San Francisco","94118",{"type":127,"coordinates":152},[153,154],-122.41942,37.77493,{"lat":154,"lon":153},[157],{"name":158,"role":110,"phone":61,"phoneExt":61,"email":61},"Elaine Tseng, MD",{"facility":160,"status":120,"city":161,"state":162,"zip":163,"country":124,"countryCode":125,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"University of Colorado","Aurora","Colorado","80045",{"type":127,"coordinates":165},[166,167],-104.83192,39.72943,{"lat":167,"lon":166},[170],{"name":171,"role":110,"phone":61,"phoneExt":61,"email":61},"Jessica Rove, MD",{"facility":173,"status":120,"city":174,"state":175,"zip":176,"country":124,"countryCode":125,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Hartford Hospital","Hartford","Connecticut","06106",{"type":127,"coordinates":178},[179,180],-72.68509,41.76371,{"lat":180,"lon":179},[183],{"name":184,"role":110,"phone":61,"phoneExt":61,"email":61},"David Yaffee, MD",{"facility":186,"status":120,"city":187,"state":175,"zip":188,"country":124,"countryCode":125,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"Yale University Hospital","New Haven","06510",{"type":127,"coordinates":190},[191,192],-72.92816,41.30815,{"lat":192,"lon":191},[195],{"name":196,"role":110,"phone":61,"phoneExt":61,"email":61},"Roland Assi, MD",{"facility":198,"status":120,"city":199,"state":200,"zip":201,"country":124,"countryCode":125,"cosmosGeoPoint":202,"geoPoint":206,"contacts":207},"Emory University","Atlanta","Georgia","30322",{"type":127,"coordinates":203},[204,205],-84.38798,33.749,{"lat":205,"lon":204},[208],{"name":209,"role":110,"phone":61,"phoneExt":61,"email":61},"John Puskas, MD",{"facility":211,"status":120,"city":212,"state":213,"zip":214,"country":124,"countryCode":125,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"University of Chicago","Chicago","Illinois","60637",{"type":127,"coordinates":216},[217,218],-87.65005,41.85003,{"lat":218,"lon":217},[221],{"name":222,"role":110,"phone":61,"phoneExt":61,"email":61},"Hasam Balkhy, MD",{"facility":224,"status":120,"city":225,"state":226,"zip":227,"country":124,"countryCode":125,"cosmosGeoPoint":228,"geoPoint":232,"contacts":233},"Indiana University","Indianapolis","Indiana","46202",{"type":127,"coordinates":229},[230,231],-86.15804,39.76838,{"lat":231,"lon":230},[234],{"name":235,"role":110,"phone":61,"phoneExt":61,"email":61},"Lola Chabtini, MD",{"facility":237,"status":120,"city":238,"state":239,"zip":240,"country":124,"countryCode":125,"cosmosGeoPoint":241,"geoPoint":245,"contacts":246},"University of Iowa","Iowa City","Iowa","52242",{"type":127,"coordinates":242},[243,244],-91.53017,41.66113,{"lat":244,"lon":243},[247],{"name":248,"role":110,"phone":61,"phoneExt":61,"email":61},"Mohammad Bashir, MD",{"facility":250,"status":120,"city":251,"state":252,"zip":253,"country":124,"countryCode":125,"cosmosGeoPoint":254,"geoPoint":258,"contacts":259},"Johns Hopkins University","Baltimore","Maryland","21218",{"type":127,"coordinates":255},[256,257],-76.61219,39.29038,{"lat":257,"lon":256},[260],{"name":261,"role":110,"phone":61,"phoneExt":61,"email":61},"Jennifer Lawton, MD",{"facility":263,"status":120,"city":264,"state":265,"zip":266,"country":124,"countryCode":125,"cosmosGeoPoint":267,"geoPoint":271,"contacts":272},"Baystate Health","Springfield","Massachusetts","01199",{"type":127,"coordinates":268},[269,270],-72.58981,42.10148,{"lat":270,"lon":269},[273],{"name":274,"role":110,"phone":61,"phoneExt":61,"email":61},"Daniel Engelman, MD",{"facility":276,"status":277,"city":278,"state":265,"zip":279,"country":124,"countryCode":125,"cosmosGeoPoint":280,"geoPoint":284,"contacts":61},"University of Massachusetts Chan Medical School","COMPLETED","Worcester","01655",{"type":127,"coordinates":281},[282,283],-71.80229,42.26259,{"lat":283,"lon":282},{"facility":286,"status":120,"city":287,"state":288,"zip":289,"country":124,"countryCode":125,"cosmosGeoPoint":290,"geoPoint":294,"contacts":295},"University of Michigan","Ann Arbor","Michigan","48104",{"type":127,"coordinates":291},[292,293],-83.74088,42.27756,{"lat":293,"lon":292},[296],{"name":297,"role":110,"phone":61,"phoneExt":61,"email":61},"Robert Hawkins, MD",{"facility":299,"status":120,"city":300,"state":288,"zip":301,"country":124,"countryCode":125,"cosmosGeoPoint":302,"geoPoint":306,"contacts":307},"Corewell Health William Beaumont University Hospital","Royal Oak","48073",{"type":127,"coordinates":303},[304,305],-83.14465,42.48948,{"lat":305,"lon":304},[308],{"name":309,"role":110,"phone":61,"phoneExt":61,"email":61},"Thomas Schwann, MD",{"facility":311,"status":120,"city":312,"state":313,"zip":314,"country":124,"countryCode":125,"cosmosGeoPoint":315,"geoPoint":319,"contacts":320},"Washington University in St. Louis","St Louis","Missouri","63110",{"type":127,"coordinates":316},[317,318],-90.19789,38.62727,{"lat":318,"lon":317},[321],{"name":322,"role":110,"phone":61,"phoneExt":61,"email":61},"Puja Kachroo, MD",{"facility":324,"status":325,"city":326,"state":327,"zip":328,"country":124,"countryCode":125,"cosmosGeoPoint":329,"geoPoint":333,"contacts":334},"Nebraska Heart Hospital","NOT_YET_RECRUITING","Lincoln","Nebraska","68526",{"type":127,"coordinates":330},[331,332],-96.66696,40.8,{"lat":332,"lon":331},[335],{"name":336,"role":110,"phone":61,"phoneExt":61,"email":61},"Omar Nass",{"facility":338,"status":120,"city":339,"state":327,"zip":340,"country":124,"countryCode":125,"cosmosGeoPoint":341,"geoPoint":345,"contacts":346},"Methodist Physicians Health","Omaha","68118",{"type":127,"coordinates":342},[343,344],-95.94043,41.25626,{"lat":344,"lon":343},[347],{"name":348,"role":110,"phone":61,"phoneExt":61,"email":61},"HelenMari Merritt-Genore, DO",{"facility":350,"status":120,"city":339,"state":327,"zip":351,"country":124,"countryCode":125,"cosmosGeoPoint":352,"geoPoint":354,"contacts":355},"University of Nebraska Medical Center","68198",{"type":127,"coordinates":353},[343,344],{"lat":344,"lon":343},[356],{"name":357,"role":110,"phone":61,"phoneExt":61,"email":61},"Aleem Siddique, MD",{"facility":359,"status":120,"city":360,"state":361,"zip":362,"country":124,"countryCode":125,"cosmosGeoPoint":363,"geoPoint":367,"contacts":368},"Englewood Health","Englewood","New Jersey","07631",{"type":127,"coordinates":364},[365,366],-73.97264,40.89288,{"lat":366,"lon":365},[369],{"name":370,"role":110,"phone":61,"phoneExt":61,"email":61},"Molly Schultheis, MD",{"facility":372,"status":120,"city":373,"state":361,"zip":374,"country":124,"countryCode":125,"cosmosGeoPoint":375,"geoPoint":379,"contacts":380},"Newark Beth Israel Medical Center","Newark","07112",{"type":127,"coordinates":376},[377,378],-74.17237,40.73566,{"lat":378,"lon":377},[381],{"name":382,"role":110,"phone":61,"phoneExt":61,"email":61},"Arash Salemi, MD",{"facility":384,"status":120,"city":385,"state":361,"zip":386,"country":124,"countryCode":125,"cosmosGeoPoint":387,"geoPoint":391,"contacts":392},"The Valley Hospital","Ridgewood","07450",{"type":127,"coordinates":388},[389,390],-74.11653,40.97926,{"lat":390,"lon":389},[393],{"name":394,"role":110,"phone":61,"phoneExt":61,"email":61},"Juan B Grau, MD",{"facility":396,"status":120,"city":397,"state":398,"zip":399,"country":124,"countryCode":125,"cosmosGeoPoint":400,"geoPoint":404,"contacts":405},"NewYork-Presbyterian Brooklyn Methodist Hospital","Brooklyn","New York","11215",{"type":127,"coordinates":401},[402,403],-73.94958,40.6501,{"lat":403,"lon":402},[406],{"name":407,"role":110,"phone":61,"phoneExt":61,"email":61},"Sandhya Balaram, MD",{"facility":409,"status":120,"city":398,"state":398,"zip":410,"country":124,"countryCode":125,"cosmosGeoPoint":411,"geoPoint":415,"contacts":416},"Weill Cornell Medicine","10021",{"type":127,"coordinates":412},[413,414],-74.00597,40.71427,{"lat":414,"lon":413},[417],{"name":92,"role":110,"phone":418,"phoneExt":61,"email":112},"212-746-1812",{"facility":420,"status":120,"city":398,"state":398,"zip":421,"country":124,"countryCode":125,"cosmosGeoPoint":422,"geoPoint":424,"contacts":425},"Columbia University Medical Center","10032",{"type":127,"coordinates":423},[413,414],{"lat":414,"lon":413},[426],{"name":427,"role":110,"phone":61,"phoneExt":61,"email":61},"Koji Takeda, MD",{"facility":429,"status":325,"city":398,"state":398,"zip":430,"country":124,"countryCode":125,"cosmosGeoPoint":431,"geoPoint":433,"contacts":434},"Lenox Hill Hospital","10075",{"type":127,"coordinates":432},[413,414],{"lat":414,"lon":413},[435],{"name":436,"role":110,"phone":61,"phoneExt":61,"email":61},"Nirav Patel, MD",{"facility":438,"status":120,"city":439,"state":398,"zip":440,"country":124,"countryCode":125,"cosmosGeoPoint":441,"geoPoint":445,"contacts":446},"New York Presbyterian Queens","Queens","11355",{"type":127,"coordinates":442},[443,444],-73.83652,40.68149,{"lat":444,"lon":443},[447],{"name":448,"role":110,"phone":61,"phoneExt":61,"email":61},"Charles Mack, MD",{"facility":107,"status":120,"city":450,"state":451,"zip":452,"country":124,"countryCode":125,"cosmosGeoPoint":453,"geoPoint":457,"contacts":458},"Durham","North Carolina","27710",{"type":127,"coordinates":454},[455,456],-78.89862,35.99403,{"lat":456,"lon":455},[459],{"name":460,"role":110,"phone":61,"phoneExt":61,"email":61},"Brittany Zwischenberger, MD",{"facility":462,"status":120,"city":463,"state":451,"zip":464,"country":124,"countryCode":125,"cosmosGeoPoint":465,"geoPoint":469,"contacts":470},"East Carolina University","Greenville","27858",{"type":127,"coordinates":466},[467,468],-77.36635,35.61266,{"lat":468,"lon":467},[471],{"name":472,"role":110,"phone":61,"phoneExt":61,"email":61},"Benjamin Degner, MD",{"facility":474,"status":120,"city":475,"state":451,"zip":476,"country":124,"countryCode":125,"cosmosGeoPoint":477,"geoPoint":481,"contacts":482},"Wake Forest University","Winston-Salem","27106",{"type":127,"coordinates":478},[479,480],-80.24422,36.09986,{"lat":480,"lon":479},[483],{"name":484,"role":110,"phone":61,"phoneExt":61,"email":61},"Bart Imielski, 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MD",{"facility":1777,"status":120,"city":835,"state":61,"zip":61,"country":1656,"countryCode":1657,"cosmosGeoPoint":1778,"geoPoint":1780,"contacts":1781},"Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital",{"type":127,"coordinates":1779},[1761,1762],{"lat":1762,"lon":1761},[1782],{"name":1783,"role":110,"phone":61,"phoneExt":61,"email":61},"Gianluca Lucchese, MD",{"facility":1785,"status":120,"city":835,"state":61,"zip":61,"country":1656,"countryCode":1657,"cosmosGeoPoint":1786,"geoPoint":1788,"contacts":1789},"St George's University Hospitals",{"type":127,"coordinates":1787},[1761,1762],{"lat":1762,"lon":1761},[1790],{"name":1791,"role":110,"phone":61,"phoneExt":61,"email":61},"Marjan Jahangiri, MD",{"facility":1793,"status":120,"city":1794,"state":61,"zip":1795,"country":1656,"countryCode":1657,"cosmosGeoPoint":1796,"geoPoint":1800,"contacts":1801},"Manchester University NHS Trust","Manchester","M13 9WL",{"type":127,"coordinates":1797},[1798,1799],-2.23743,53.48095,{"lat":1799,"lon":1798},[1802],{"name":1803,"role":110,"phone":61,"phoneExt":61,"email":61},"Nnamdi Nwaejike, MD",{"facility":1805,"status":120,"city":1806,"state":61,"zip":1807,"country":1656,"countryCode":1657,"cosmosGeoPoint":1808,"geoPoint":1812,"contacts":1813},"South Tees Hospitals NHS Trust","Middlesbrough","TS4 3BW",{"type":127,"coordinates":1809},[1810,1811],-1.23483,54.57623,{"lat":1811,"lon":1810},[1814],{"name":1815,"role":110,"phone":61,"phoneExt":61,"email":61},"Ralph White, MD",{"facility":1817,"status":120,"city":1818,"state":61,"zip":1819,"country":1656,"countryCode":1657,"cosmosGeoPoint":1820,"geoPoint":1824,"contacts":1825},"Sheffield Teaching Hospitals NHS Foundation Trust","Sheffield","S10 2SB",{"type":127,"coordinates":1821},[1822,1823],-1.4659,53.38297,{"lat":1823,"lon":1822},[1826],{"name":1827,"role":110,"phone":61,"phoneExt":61,"email":61},"Govind Chetty, MBBS",{"facility":1829,"status":120,"city":1830,"state":61,"zip":61,"country":1656,"countryCode":1657,"cosmosGeoPoint":1831,"geoPoint":1835,"contacts":1836},"Mid and South Essex NHS Foundation Trust","Westcliff-on-Sea",{"type":127,"coordinates":1832},[1833,1834],0.69179,51.54424,{"lat":1834,"lon":1833},[1837],{"name":1838,"role":110,"phone":61,"phoneExt":61,"email":61},"Arvind Singh",{"facility":1840,"status":120,"city":1841,"state":61,"zip":1842,"country":1656,"countryCode":1657,"cosmosGeoPoint":1843,"geoPoint":1847,"contacts":1848},"Royal Wolverhampton NHS Trust","Wolverhampton","WV10 0QP",{"type":127,"coordinates":1844},[1845,1846],-2.12296,52.58547,{"lat":1846,"lon":1845},[1849],{"name":1850,"role":110,"phone":61,"phoneExt":61,"email":61},"Giuseppe Rescigno, MD",{"type":1852,"investigatorFullName":61,"investigatorTitle":61,"investigatorAffiliation":61,"oldNameTitle":61,"oldOrganization":61},"SPONSOR",[1854,1856,1857,1858,1859],{"name":1855,"class":6},"New York Presbyterian Hospital",{"name":96,"class":6},{"name":119,"class":6},{"name":99,"class":6},{"name":107,"class":6},"100372032","comparison-of-the-outcomes-of-single-vs-multiple-arterial-grafts-in-women-100372032",false,"NCT04124120","Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women","Randomized Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women (ROMA:Women) Trial","ROMA:Women","Inclusion Criteria:\n\n1. Women patients ≥18 years old.\n2. Isolated coronary artery bypass grafting.\n3. Primary (first time) cardiac surgery procedure.\n4. 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.\n\nExclusion Criteria:\n\n* Male gender\n* Single graft\n* Emergency operation\n* Myocardial infarction within 72 hours of surgery\n* Left ventricular ejection fraction \\\u003C 35%\n* Any concomitant cardiac or non-cardiac procedure\n* Previous cardiac surgery\n* Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure), cancer or any co-morbidity that reduces life expectancy to less than 5 years.\n* Inability to use the saphenous vein or to use both radial and right internal thoracic arteries\n* Anticipated need for coronary thrombo-endarterectomy\n* Planned hybrid revascularization","FEMALE","18 Years",{"count":1871,"type":1872},2300,"ESTIMATED","INTERVENTIONAL",[1875],"NA","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).\n\nThe specific aims of ROMA:Women are:\n\nAim 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.\n\nHypothesis 1.0. MAG will reduce the incidence of major adverse cardiac and cerebrovascular events.\n\nHypothesis 1.1. The improvement with MAG will be consistent across key subgroups.\n\nAim 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.\n\nHypothesis 2.0. MAG will improve generic and disease-specific QOL compared to SAG.\n\nHypothesis 2.1. MAG will improve physical and mental health symptoms compared to SAG.\n\nHypothesis 2.2. The improvement with MAG will be consistent across key subgroups.",[1878,1879,1880],"Heart Diseases","Coronary Artery Disease","Coronary Artery Bypass Grafting","2026-03-31",{"date":1883,"type":1884},"2026-04-01","ACTUAL",{"date":1886,"type":1884},"2023-04-17",{"date":1888,"type":1872},"2030-03",{"name":5,"class":6},146]