Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-02 @ 5:34 PM
Study NCT ID:
NCT04124120
Status:
RECRUITING
Last Update Posted:
2025-04-06
First Post:
2019-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The endpoint assessors will be blinded to treatment allocation (PROBE).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2030-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2019-10-10', 'studyFirstSubmitQcDate': '2019-10-10', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Other recorded outcomes (safety endpoints)', 'timeFrame': 'Within 30 days of surgery or during index hospitalization, whichever is longer.', 'description': '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).'}], 'primaryOutcomes': [{'measure': '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.', 'timeFrame': 'Postoperatively, minimum 2.5 year follow-up', 'description': '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.'}, {'measure': 'Primary outcome for aim 2: Disease-specific quality of life', 'timeFrame': 'Postoperatively, minimum 2.5 year follow-up', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Death from any cause, any stroke, non-procedural myocardial infarction, and repeat revascularization.', 'timeFrame': 'Postoperatively, minimum 2.5 year follow-up', 'description': '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': 'Death from cardiac cause, any stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.', 'timeFrame': 'Postoperatively, minimum 2.5 year follow-up', 'description': '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': 'Death from any cause', 'timeFrame': 'Postoperatively, minimum 2.5 year follow-up', 'description': 'Another secondary outcome for aim 1: Death will be considered to be cardiac unless a definite non-cardiac cause is identified.'}, {'measure': 'Stroke', 'timeFrame': 'Postoperatively, minimum 2.5 year follow-up', 'description': '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:\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': 'Non-procedural myocardial infarction', 'timeFrame': '> 48 hours postoperatively, minimum 2.5 year follow-up', 'description': '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:\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.'}, {'measure': 'Repeat revascularization', 'timeFrame': 'Postoperatively, minimum 2.5 year follow-up', 'description': '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': 'Readmission for acute coronary syndrome', 'timeFrame': 'Postoperatively, minimum 2.5 year follow-up', 'description': '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': 'Readmission for heart failure', 'timeFrame': 'Postoperatively, minimum 2.5 year follow-up', 'description': '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/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.'}, {'measure': 'Generic quality of life according to the Short Form Health Survey (SF-12v2)', 'timeFrame': 'Postoperatively, minimum 2.5 year follow-up', 'description': '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': 'Generic quality of life according to EuroQuol-5D (EQ-5D)', 'timeFrame': 'Postoperatively, minimum 2.5 year follow-up', 'description': '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': 'Mental and physical health symptoms according to PROMIS instruments', 'timeFrame': 'Postoperatively, minimum 2.5 year follow-up', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Diseases', 'Coronary Artery Disease', 'Coronary Artery Bypass Grafting']}, 'referencesModule': {'references': [{'pmid': '3484393', 'type': 'BACKGROUND', '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.'}, {'pmid': '14726042', 'type': 'BACKGROUND', '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.'}, {'pmid': '10220677', 'type': 'BACKGROUND', '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.'}, {'pmid': '11567701', 'type': 'BACKGROUND', '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."}, {'pmid': '24916209', 'type': 'BACKGROUND', '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.'}, {'pmid': '22070836', 'type': 'BACKGROUND', '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.'}, {'pmid': '25173339', 'type': 'BACKGROUND', '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.'}, {'pmid': '26680310', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24686003', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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).\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 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.\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.', 'detailedDescription': '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 2,000 women randomized 1:1 to MAG or SAG (690 from the parent ROMA trial + 1,310 from ROMA:Women). 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/personnel, 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': '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 \\< 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'}, 'identificationModule': {'nctId': 'NCT04124120', 'acronym': 'ROMA:Women', 'briefTitle': 'Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Randomized Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women (ROMA:Women) Trial', 'orgStudyIdInfo': {'id': '1703018094-ROMA-Women'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arterial Graft (SAG) group', 'description': '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.', 'interventionNames': ['Procedure: Single arterial graft']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple Arterial Graft (MAG) group', 'description': '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.', 'interventionNames': ['Procedure: Multiple arterial grafting']}], 'interventions': [{'name': 'Single arterial graft', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Single Arterial Graft (SAG) group']}, {'name': 'Multiple arterial grafting', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Multiple Arterial Graft (MAG) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joanna Chikwe, MD', 'role': 'CONTACT'}], 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91767', 'city': 'Pomona', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christine Montesa, MD', 'role': 'CONTACT'}], 'facility': 'Pomona Valley Hospital Medical Center', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}, {'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elaine Tseng, MD', 'role': 'CONTACT'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Rove, MD', 'role': 'CONTACT'}], 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Yaffee, MD', 'role': 'CONTACT'}], 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Roland Assi, MD', 'role': 'CONTACT'}], 'facility': 'Yale University Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alison Ward, MD', 'role': 'CONTACT'}], 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hasam Balkhy, MD', 'role': 'CONTACT'}], 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mohammad Bashir, MD', 'role': 'CONTACT'}], 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Lawton, MD', 'role': 'CONTACT'}], 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daniel Engelman, MD', 'role': 'CONTACT'}], 'facility': 'Baystate Health', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Leora Balsam, MD', 'role': 'CONTACT'}], 'facility': 'University of Massachusetts Chan Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48104', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robert Hawkins, MD', 'role': 'CONTACT'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Thomas Schwann, MD', 'role': 'CONTACT'}], 'facility': 'Corewell Health William Beaumont University Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Puja Kachroo, MD', 'role': 'CONTACT'}], 'facility': 'Washington University in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68526', 'city': 'Lincoln', 'state': 'Nebraska', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Omar Nass', 'role': 'CONTACT'}], 'facility': 'Nebraska Heart Hospital', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68118', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'HelenMari Merritt-Genore, DO', 'role': 'CONTACT'}], 'facility': 'Methodist Physicians Health', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aleem Siddique, MD', 'role': 'CONTACT'}], 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07631', 'city': 'Englewood', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Molly Schultheis, MD', 'role': 'CONTACT'}], 'facility': 'Englewood Health', 'geoPoint': {'lat': 40.89288, 'lon': -73.97264}}, {'zip': '07112', 'city': 'Newark', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Arash Salemi, MD', 'role': 'CONTACT'}], 'facility': 'Newark Beth Israel Medical Center', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '07450', 'city': 'Ridgewood', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Juan B Grau, MD', 'role': 'CONTACT'}], 'facility': 'The Valley Hospital', 'geoPoint': {'lat': 40.97926, 'lon': -74.11653}}, {'zip': '11215', 'city': 'Brooklyn', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sandhya 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'contacts': [{'name': 'Andre Lamy, MD', 'role': 'CONTACT'}], 'facility': 'Hamilton General Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'David Nagpal, MD', 'role': 'CONTACT'}], 'facility': 'London Health Sciences', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'K1Y 4W7', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Marc Ruel, MD', 'role': 'CONTACT'}], 'facility': 'University of Ottawa Heart Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Stephen E Fremes, MD', 'role': 'CONTACT'}], 'facility': 'Sunnybrook Health Sciences', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Vivek Rao, MD', 'role': 'CONTACT'}], 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Philippe Demers, MD', 'role': 'CONTACT'}], 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2X 3E4', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jessica Forcillo, MD', 'role': 'CONTACT'}], 'facility': 'University Hospital of Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4A 3J1', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Kevin Lachapelle, MD', 'role': 'CONTACT'}], 'facility': 'Royal Victoria Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4G5', 'city': 'Ste Foy', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Mohamed Marzouk, MD', 'role': 'CONTACT'}], 'facility': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec'}, {'city': 'Montreal', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Hugues Jeanmart, MD', 'role': 'CONTACT'}], 'facility': 'Hopital Sacre-Coeur', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'New Westminster', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Daniel Wong, MD', 'role': 'CONTACT'}], 'facility': 'Fraser Clinical Trials', 'geoPoint': {'lat': 49.20678, 'lon': -122.91092}}, {'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhe Zheng, MD', 'role': 'CONTACT'}], 'facility': 'Fuwai Hospital China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '130052', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Massimo Lemma, MD', 'role': 'CONTACT'}], 'facility': 'Jilin Heart Hospital China', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiang Zhao, MD', 'role': 'CONTACT'}], 'facility': 'Ruijin Hospital Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '300456', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guo-Wei He, MD', 'role': 'CONTACT'}], 'facility': 'Teda Hospital Tianjin China', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '10000', 'city': 'Zagreb', 'status': 'RECRUITING', 'country': 'Croatia', 'contacts': [{'name': 'Igor Rudez, MD', 'role': 'CONTACT'}], 'facility': 'University Hospital Dubrava', 'geoPoint': {'lat': 45.81444, 'lon': 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'79189', 'city': 'Bad Krozingen', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Martin Czerny, MD', 'role': 'CONTACT'}], 'facility': 'Universitäts-Herzzentrum Bad Krozingen Freiburg', 'geoPoint': {'lat': 47.91667, 'lon': 7.7}}, {'zip': '32545', 'city': 'Bad Oeynhausen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Marcus-Andre Deutsch, MD', 'role': 'CONTACT'}], 'facility': 'HDZ NRW Bad Oeynhausen Germany', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stephan Jacobs', 'role': 'CONTACT'}], 'facility': 'Deutsches Herzzentrum der Charite', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '47137', 'city': 'Duisburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jochen Börgermann, MD', 'role': 'CONTACT'}], 'facility': 'Duisburg Heart Center', 'geoPoint': {'lat': 51.43247, 'lon': 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'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Marc Albert, MD', 'role': 'CONTACT'}], 'facility': 'Robert-Bosch-Hospital Stuttgart Germany', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '54292', 'city': 'Trier', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Terrence J Donovan, MD', 'role': 'CONTACT'}], 'facility': 'Krankenhaus der Barmherzigen Brüder Trier', 'geoPoint': {'lat': 49.75565, 'lon': 6.63935}}, {'zip': '641037', 'city': 'Coimbatore', 'state': 'Tamil Nadu', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Chandra Padmanabhan, MD', 'role': 'CONTACT'}], 'facility': 'G Kuppuswamy Naidu Memorial Hospital (GKNM)', 'geoPoint': {'lat': 11.00555, 'lon': 76.96612}}, {'zip': '500034', 'city': 'Hyderabad', 'state': 'Telangana', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Gopichand Mannam, MD', 'role': 'CONTACT'}], 'facility': 'Star Hospitals - Hyderabad, India', 'geoPoint': {'lat': 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