Coronary Artery Disease Clinical Trial
— ROMA:WomenOfficial title:
Randomized Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women (ROMA:Women) 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 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.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | March 2030 |
Est. primary completion date | March 2030 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | The University of Melbourne | Melbourne | |
Austria | Medical University of Graz | Graz | |
Austria | Innsbruck Medical University | Innsbruck | |
Austria | Kepler University Hospital | Linz | |
Austria | Krankenhaus Nord Vienna North Hospital | Vienna | |
Austria | Medical University of Vienna | Vienna | |
Brazil | Institute of Cardiology Porto Alegre | Porto Alegre | |
Brazil | Heart Institute University of São Paulo | São Paulo | |
Brazil | Instituto Dante Pazzanese de Cardiologia | Vila Mariana | |
Canada | Hamilton General Hospital | Hamilton | Ontario |
Canada | London Health Sciences | London | Ontario |
Canada | Hopital Sacre-Coeur | Montréal | |
Canada | Montreal Heart Institute | Montréal | Quebec |
Canada | Royal Victoria Hospital | Montréal | Quebec |
Canada | University Hospital of Montreal | Montréal | Quebec |
Canada | Fraser Clinical Trials | New Westminster | |
Canada | University of Ottawa Heart Institute | Ottawa | Ontario |
Canada | Horizon Health Network - Saint John Regional Hospital | Saint John | New Brunswick |
Canada | Institut Universitaire de Cardiologie et de Pneumologie de Québec | Ste Foy | Quebec |
Canada | Health Sciences North | Sudbury | Ontario |
Canada | Sunnybrook Health Sciences | Toronto | Ontario |
Canada | Toronto General Hospital | Toronto | Ontario |
Canada | St. Boniface General Hospital | Winnipeg | Manitoba |
China | Fuwai Hospital China | Beijing | Beijing |
China | Jilin Heart Hospital China | Changchun | Jilin |
China | Ruijin Hospital Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai |
China | Teda Hospital Tianjin China | Tianjin | Tianjin |
Croatia | University Hospital Dubrava | Zagreb | |
Czechia | University Hradec Králové | Hradec Králové | |
Czechia | General University Hospital, Prague | Nové Mesto | |
Germany | Universitäts-Herzzentrum Bad Krozingen Freiburg | Bad Krozingen | Baden-Wuerttemberg |
Germany | HDZ NRW Bad Oeynhausen Germany | Bad Oeynhausen | |
Germany | Deutsches Herzzentrum der Charite | Berlin | |
Germany | Duisburg Heart Center | Duisburg | |
Germany | Essen University | Duisburg | |
Germany | Dusseldorf University | Düsseldorf | |
Germany | University Hospital Erlangen | Erlangen | |
Germany | Frankfurt University | Frankfurt | |
Germany | University Hospital of Giessen and Marburg | Gießen | |
Germany | University Medical Center of Göttingen | Göttingen | |
Germany | Jena University Hospital | Jena | |
Germany | Heart Center Herzzentrum, Leipzig | Leipzig | |
Germany | Robert-Bosch-Hospital Stuttgart Germany | Stuttgart | |
Germany | Krankenhaus der Barmherzigen Brüder Trier | Trier | |
India | G Kuppuswamy Naidu Memorial Hospital (GKNM) | Coimbatore | Tamil Nadu |
India | Star Hospitals - Hyderabad, India | Hyderabad | Telangana |
Israel | Rambam Health Care Campus | Haifa | |
Italy | Anthea Hospital | Bari | |
Italy | Fondazione Poliambulanza | Brescia | |
Italy | Maria Cecilia Hospital GVM | Cotignola | |
Italy | European Hospital | Roma | |
Italy | Universita' Cattolica del Sacro Cuore | Roma | |
Italy | Ospedale Le Molinette, Torino | Torino | |
Japan | Tokyo Medical and Dental University | Bunkyo-Ku | Tokyo |
Japan | Saitama Medical University Japan | Saitama | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | Severance Cardiovascular Hospital, Yonsei University College of Medicine | Seúl | |
Netherlands | Maastricht University Medical Centre | Maastricht | |
North Macedonia | Acibadem-Sistina Hospital | Skopje | |
Poland | Medical University of Silesia | Katowice | |
Poland | Zbigniew Religa Lower Silesian Heart Disease Centre | Zabrze | |
Portugal | University Hospital Coimbra | Coimbra | |
Portugal | Centro Hospitalar Lisboa Ocidental | Lisboa | |
Portugal | Centro Hospitalar e Universitário Sao João | Porto | |
Russian Federation | National Research Medical Center of the Russian Academy of Sciences - Tomsk, Russia | Tomsk | |
Serbia | Dedinje Cardiovascular Institute | Belgrade | |
Singapore | National University of Singapore | Singapore | |
Spain | Hospital Clinic de Barcelona | Barcelona | |
Spain | Hospital Universitario del Vinalopo | Elx | Alicante |
Spain | Hospital Clinico de San Carlos | Madrid | |
Spain | NavarraBiomed | Pamplona | |
Sweden | Sahlgrenska University Hospital | Gothenburg | |
Taiwan | National Taiwan University Hospital | Zhongzheng | Taipei |
United Kingdom | Hull University Hospitals | Hull | |
United Kingdom | University Hospitals of Leicester | Leicester | |
United Kingdom | St George's University Hospitals | London | |
United States | University of Colorado | Aurora | Colorado |
United States | Johns Hopkins University | Baltimore | Maryland |
United States | NewYork-Presbyterian Brooklyn Methodist Hospital | Brooklyn | New York |
United States | University of Chicago | Chicago | Illinois |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Ohio State University | Columbus | Ohio |
United States | Baylor Scott & White Research Institute | Dallas | Texas |
United States | Duke University | Durham | North Carolina |
United States | Englewood Health | Englewood | New Jersey |
United States | Nebraska Heart Hospital | Lincoln | Nebraska |
United States | Cedars-Sinai Medical Center | Los Angeles | California |
United States | Yale University Hospital | New Haven | Connecticut |
United States | Columbia University Medical Center | New York | New York |
United States | Icahn School of Medicine, Mount Sinai | New York | New York |
United States | Lenox Hill Hospital | New York | New York |
United States | Weill Cornell Medicine | New York | New York |
United States | Newark Beth Israel Medical Center | Newark | New Jersey |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | New York Presbyterian Queens | Queens | New York |
United States | The Valley Hospital | Ridgewood | New Jersey |
United States | Washington University in St. Louis | Saint Louis | Missouri |
United States | University of Utah | Salt Lake City | Utah |
United States | Baystate Health | Springfield | Massachusetts |
United States | Lankenau Medical Center | Wynnewood | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University | Cedars-Sinai Medical Center, Columbia University, Duke University, New York Presbyterian Hospital, Sunnybrook Health Sciences Centre |
United States, Australia, Austria, Brazil, Canada, China, Croatia, Czechia, Germany, India, Israel, Italy, Japan, Korea, Republic of, Netherlands, North Macedonia, Poland, Portugal, Russian Federation, Serbia, Singapore, Spain, Sweden, Taiwan, United Kingdom,
Aldea GS, Bakaeen FG, Pal J, Fremes S, Head SJ, Sabik J, Rosengart T, Kappetein AP, Thourani VH, Firestone S, Mitchell JD; Society of Thoracic Surgeons. The Society of Thoracic Surgeons Clinical Practice Guidelines on Arterial Conduits for Coronary Artery Bypass Grafting. Ann Thorac Surg. 2016 Feb;101(2):801-9. doi: 10.1016/j.athoracsur.2015.09.100. Epub 2015 Dec 8. — View Citation
Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available. — View Citation
Benedetto U, Raja SG, Albanese A, Amrani M, Biondi-Zoccai G, Frati G. Searching for the second best graft for coronary artery bypass surgery: a network meta-analysis of randomized controlled trialsdagger. Eur J Cardiothorac Surg. 2015 Jan;47(1):59-65; discussion 65. doi: 10.1093/ejcts/ezu111. Epub 2014 Mar 30. — View Citation
Hillis LD, Smith PK, Anderson JL, Bittl JA, Bridges CR, Byrne JG, Cigarroa JE, Disesa VJ, Hiratzka LF, Hutter AM Jr, Jessen ME, Keeley EC, Lahey SJ, Lange RA, London MJ, Mack MJ, Patel MR, Puskas JD, Sabik JF, Selnes O, Shahian DM, Trost JC, Winniford MD; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; Society of Cardiovascular Anesthesiologists; Society of Thoracic Surgeons. 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Developed in collaboration with the American Association for Thoracic Surgery, Society of Cardiovascular Anesthesiologists, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2011 Dec 6;58(24):e123-210. doi: 10.1016/j.jacc.2011.08.009. Epub 2011 Nov 7. No abstract available. — View Citation
Loop FD, Lytle BW, Cosgrove DM, Stewart RW, Goormastic M, Williams GW, Golding LA, Gill CC, Taylor PC, Sheldon WC, et al. Influence of the internal-mammary-artery graft on 10-year survival and other cardiac events. N Engl J Med. 1986 Jan 2;314(1):1-6. doi: 10.1056/NEJM198601023140101. — View Citation
Lytle BW, Blackstone EH, Loop FD, Houghtaling PL, Arnold JH, Akhrass R, McCarthy PM, Cosgrove DM. Two internal thoracic artery grafts are better than one. J Thorac Cardiovasc Surg. 1999 May;117(5):855-72. doi: 10.1016/S0022-5223(99)70365-X. — View Citation
Taggart DP, D'Amico R, Altman DG. Effect of arterial revascularisation on survival: a systematic review of studies comparing bilateral and single internal mammary arteries. Lancet. 2001 Sep 15;358(9285):870-5. doi: 10.1016/S0140-6736(01)06069-X. — View Citation
Tatoulis J, Buxton BF, Fuller JA. Patencies of 2127 arterial to coronary conduits over 15 years. Ann Thorac Surg. 2004 Jan;77(1):93-101. doi: 10.1016/s0003-4975(03)01331-6. — View Citation
Yi G, Shine B, Rehman SM, Altman DG, Taggart DP. Effect of bilateral internal mammary artery grafts on long-term survival: a meta-analysis approach. Circulation. 2014 Aug 12;130(7):539-45. doi: 10.1161/CIRCULATIONAHA.113.004255. Epub 2014 Jun 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Other recorded outcomes (safety endpoints) | 30-day mortality and major postoperative complications (revision for bleeding, perioperative MI (<48 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. | |
Primary | 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 | |
Primary | 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. The primary endpoint for aim 2 is the absolute change in the Seattle Angina Questionnaire (SAQ) at 12 months compared to baseline. |
Postoperatively, minimum 2.5 year follow-up | |
Secondary | 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. This is the primary outcome of the parent ROMA trial. |
Postoperatively, minimum 2.5 year follow-up | |
Secondary | 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. | Postoperatively, minimum 2.5 year follow-up | |
Secondary | 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. | Postoperatively, minimum 2.5 year follow-up | |
Secondary | Stroke | Another secondary outcome for aim 1: Based on the American Heart Association/American Stroke Association Expert Consensus stroke definition, stroke will be identified in case of: pathological, imaging, or other objective evidence of cerebral ischemic injury in a defined vascular distribution; OR clinical evidence of cerebral ischemic injury based on symptoms persisting =24 hours or until death, and other etiologies excluded. |
Postoperatively, minimum 2.5 year follow-up | |
Secondary | 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/or 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: symptoms of ischemia electrocardiogram changes indicative of new ischemia (new ST-T changes or new left bundle branch block) development of pathological Q waves in the electrocardiogram imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. |
> 48 hours postoperatively, minimum 2.5 year follow-up | |
Secondary | 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. | Postoperatively, minimum 2.5 year follow-up | |
Secondary | 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. | Postoperatively, minimum 2.5 year follow-up | |
Secondary | 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: i. Requires hospitalization AND ii. Clinical symptoms of heart failure AND iii. Physical signs of heart failure AND iv. Need for additional/increased 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. |
Postoperatively, minimum 2.5 year follow-up | |
Secondary | 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. The 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. |
Postoperatively, minimum 2.5 year follow-up | |
Secondary | 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. | Postoperatively, minimum 2.5 year follow-up | |
Secondary | 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. | Postoperatively, minimum 2.5 year follow-up |
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