Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2026-03-07 @ 10:43 PM
Study NCT ID:
NCT05591118
Status:
RECRUITING
Last Update Posted:
2025-06-19
First Post:
2022-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-06-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2022-10-18', 'studyFirstSubmitQcDate': '2022-10-18', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Oxygen Consumption (PVO2)', 'timeFrame': 'Month 3', 'description': 'PVO2 measured during cardiopulmonary exercise test (CPET).'}, {'measure': 'New York Heart Association (NYHA) Functional Classification', 'timeFrame': 'Month 12', 'description': 'The NYHA classifies the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity; the limitations/symptoms are in regards to normal breathing and varying degrees in shortness of breath and or angina pain:\n\n* Class I - No symptoms and no limitation with ordinary physical activity.\n* Class II - Mild symptoms and slight limitation during ordinary activity.\n* Class III - Moderate limitation in activity (even less than ordinary) due to symptoms.\n* Class IV - Symptoms occur at rest and severe limitation with any physical activity.\n* Class V - Dead.'}, {'measure': 'Incidence of Major Bleeding at Day 7', 'timeFrame': 'Up to Day 7', 'description': 'International Society on Thrombosis and Haemostasis (ISTH) definition of "Major Bleeding" to be used. Per ISTH, Major Bleeding defined as:\n\n1. Fatal bleeding, AND/OR;\n2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, AND/OR;\n3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.'}], 'secondaryOutcomes': [{'measure': 'Six-Minute Walk Distance (6MWD)', 'timeFrame': 'Month 12'}, {'measure': 'Short-Form Health Survey-36 (SF-36) Score', 'timeFrame': 'Month 12', 'description': '36-item questionnaire assessing general health. It measures 8 dimensions of health status: social function, physical function, emotional role, physical role, mental health, vitality, physical pain, and general health. Scores range from 0 (worst health status) to 100 (best health status).'}, {'measure': 'Incidence of Clinical Deterioration (Fatal and Non-Fatal) at Day 7', 'timeFrame': 'Up to Day 7', 'description': 'Clinical deterioration defined as hemodynamic decompensation or respiratory decompensation requiring endotracheal intubation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Catheter-Directed Therapy (CDT)'], 'conditions': ['Pulmonary Embolism']}, 'referencesModule': {'references': [{'pmid': '39638275', 'type': 'DERIVED', 'citation': 'Sista AK, Troxel AB, Tarpey T, Parpia S, Goldhaber SZ, Stringer WW, Magnuson EA, Cohen DJ, Kahn SR, Rao SV, Morris TA, Goldfeld KS, Vedantham S. Rationale and design of the PE-TRACT trial: A multicenter randomized trial to evaluate catheter-directed therapy for the treatment of intermediate-risk pulmonary embolism. Am Heart J. 2025 Mar;281:112-122. doi: 10.1016/j.ahj.2024.11.016. Epub 2024 Dec 3.'}]}, 'descriptionModule': {'briefSummary': 'PE-TRACT is an open-label, assessor-blinded, randomized trial, aiming to compare catheter-directed therapy (CDT) and anticoagulation (CDT group) with anticoagulation alone (No-CDT) in 500 patients with submassive PE, proximal pulmonary artery thrombus and right ventricular dilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Symptomatic PE diagnosed by contrast-enhanced CT angiography with involvement of a main or lobar pulmonary artery branch; and\n2. Right ventricular (RV) dilation as defined by the presence of an RV/Left ventricular ratio \\> 1 on CT angiography\n\nExclusion Criteria:\n\n1. Age \\< 18 years\n2. Systolic blood pressure \\< 90 mmHg for \\>15 consecutive minutes or \\> 40 mmHg drop from baseline, or vasopressor requirement for blood pressure support (i.e., massive PE), occurring within 1 hour prior to eligibility assessment.\n3. Symptom duration \\> 14 days for the current PE episode\n4. Irreversible INR \\> 3\n5. Irreversible Thrombocytopenia (Platelets \\< 50,000/microliter)\n6. Creatinine \\> 2.0 mg/dl\n7. Hemoglobin \\< 7.0 g/dl\n8. Pregnancy (positive urine or blood pregnancy test (a pregnancy test must be obtained within 7 days prior to randomization in people of childbearing potential))\n9. Allergy or hypersensitivity to Recombinant Tissue Plasminogen Activator (rt-PA), or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used\n10. Life expectancy \\< 1 year\n11. Chronic inability to independently walk prior to the current PE episode (e.g. wheelchair dependent, walker or cane dependent, paraplegic, and/or bed-bound)\n12. Allergy to heparin or history of Heparin-Induced Thrombocytopenia (HIT)\n13. Unable or unwilling to provide informed consent\n14. Major contraindication or unsuitability for all CDT methods available at the Clinical Center'}, 'identificationModule': {'nctId': 'NCT05591118', 'acronym': 'PE-TRACT', 'briefTitle': 'Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy', 'orgStudyIdInfo': {'id': '22-01272'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Catheter-Directed Therapy (CDT) plus Anticoagulation', 'description': 'Participants will receive CDT consisting of mechanical thrombectomy (MT) or intrathrombus catheter-directed thrombolysis (CDL) using FDA-cleared devices for pulmonary embolism (PE). The exact technique and devices used will be at the discretion of the endovascular physician, within parameters defined by the PE-TRACT Manual of Operations (MOP) and accepted standard care. Before and after CDT, patients will receive standard PE therapy as in the no-CDT Arm.', 'interventionNames': ['Drug: Anticoagulant Therapy', 'Device: Catheter-Directed Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No Catheter-Directed Therapy (No-CDT)', 'description': 'Standard anticoagulant therapy (FDA-approved regimen) for the treatment of PE.', 'interventionNames': ['Drug: Anticoagulant Therapy']}], 'interventions': [{'name': 'Anticoagulant Therapy', 'type': 'DRUG', 'description': 'All subjects will receive anticoagulation for a minimum of 3 months.', 'armGroupLabels': ['Catheter-Directed Therapy (CDT) plus Anticoagulation', 'No Catheter-Directed Therapy (No-CDT)']}, {'name': 'Catheter-Directed Therapy', 'type': 'DEVICE', 'description': 'The endovascular physician can choose to use either mechanical thrombectomy (MT) using a device cleared by the FDA to treat PE or catheter-directed thrombolysis (CDL) using an infusion catheter cleared by the FDA to administer thrombolytic drugs for the treatment of PE', 'armGroupLabels': ['Catheter-Directed Therapy (CDT) plus Anticoagulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Samuel McElwee, MD', 'role': 'CONTACT', 'email': 'skmcelwee@uabmc.edu', 'phone': '205-975-7123'}], 'facility': 'The University of Alabama At Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andrew Kesselman, MD', 'role': 'CONTACT', 'email': 'ajk266@stanford.edu', 'phone': '650-723-6855'}], 'facility': 'Stanford Medicine', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Roger Goldman', 'role': 'CONTACT', 'email': 'regoldman@ucdavis.edu', 'phone': '916-734-8462'}], 'facility': 'UC Davis Health', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92121', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daniel S. Jones, MD', 'role': 'CONTACT', 'email': 'Jones.Daniel@scrippshealth.org', 'phone': '215-908-5726'}], 'facility': 'Scripps Memorial Hospital, La Jolla', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Janine Vintch, MD', 'role': 'CONTACT', 'email': 'jvintch@dhs.lacounty.gov', 'phone': '310-222-8200'}], 'facility': 'The Lundquist Institute', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'George Kimbiris, MD', 'role': 'CONTACT', 'email': 'gkimbiris@christianacare.org', 'phone': '302-733-5625'}, {'name': 'George Kimbiris, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Christiana Care', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Saher Sabri, MD', 'role': 'CONTACT', 'email': 'saher.s.sabri@medstar.net', 'phone': '202-877-3657'}], 'facility': 'MedStar Health Research Institute', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ripal Gandhi, MD', 'role': 'CONTACT', 'email': 'gandhi@baptisthealth.net', 'phone': '786-596-5990'}, {'name': 'Ripal Gandhi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baptist Health Miami Cardiac & Vascular Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Glenn Hoots, MD', 'role': 'CONTACT', 'email': 'hoots@usf.edu', 'phone': '813-844-4570'}], 'facility': 'University of South Florida/ Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Wissam Jabar, MD', 'role': 'CONTACT', 'email': 'wissam.jaber@emory.edu', 'phone': '404-686-7568'}, {'name': 'Wissam Jabar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emory University School of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jonathan D. Paul, MD', 'role': 'CONTACT', 'email': 'jpaul@medicine.bsd.uchicago.edu', 'phone': '773-834-1497'}], 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60515', 'city': 'Downers Grove', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mahesh Raju, MD', 'role': 'CONTACT', 'email': 'Mahesh.raju@aah.org', 'phone': '630-719-4799'}, {'name': 'Mahesh Raju, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Advocate Good Samaritan Hospital', 'geoPoint': {'lat': 41.80892, 'lon': -88.01117}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amir Darki, MD', 'role': 'CONTACT', 'email': 'adarki@lumc.edu', 'phone': '708-216-4466'}], 'facility': 'Loyola University Chicago', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '62781', 'city': 'Springfield', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Abdul Moiz Hafiz', 'role': 'CONTACT', 'email': 'ahafiz96@siumed.edu', 'phone': '217-545-8000'}], 'facility': 'Southern Illinois University School of Medicine', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kevin Doerschug', 'role': 'CONTACT', 'email': 'kevin-doerschug@uiowa.edu', 'phone': '319-356-1445'}], 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '04102', 'city': 'Portland', 'state': 'Maine', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Paul Kim, MD', 'role': 'CONTACT', 'email': 'kimp9@spectrummg.com', 'phone': '207-956-6650'}], 'facility': 'MaineHealth', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashvin Pande, MD', 'role': 'CONTACT', 'email': 'Ashvin.pande@bmc.org', 'phone': '617-638-8703'}, {'name': 'Ashvin Pande, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brett Carroll, MD', 'role': 'CONTACT', 'email': 'bcarrol2@bidmc.harvard.edu', 'phone': '617-667-8800'}, {'name': 'Brett Carroll, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Minhajuddin Khaja, MD, MBA', 'role': 'CONTACT', 'email': 'mkhaja@med.umich.edu', 'phone': '734-936-4478'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48197', 'city': 'Ypsilanti', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hriday Shah, MD', 'role': 'CONTACT', 'email': 'hriday.shah@aiarad.com', 'phone': '734-712-8350'}], 'facility': 'Trinity Health - Ann Arbor Hospital', 'geoPoint': {'lat': 42.24115, 'lon': -83.61299}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Pavan Kavali, MD', 'role': 'CONTACT', 'email': 'pavan.kavali@wustl.edu', 'phone': '314-362-2900'}], 'facility': 'Washington University in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Abhishek Kumar, M.D.', 'role': 'CONTACT', 'email': 'kumarab@njms.rutgers.edu', 'phone': '973-972-5188'}], 'facility': 'Rutgers New Jersey Medical School', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Carolina Ponce Orellana, MD', 'role': 'CONTACT', 'email': 'CPonceOr@salud.unm.edu', 'phone': '505-272-6020'}], 'facility': 'University of New Mexico Health Sciences Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bedros Taslakian, MD, EBIR, FCIRSE', 'role': 'CONTACT', 'email': 'bedros.taslakian@nyulangone.org', 'phone': '332-237-9866'}], 'facility': 'NYU Langone Health - Tisch Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hooman Poor, MD', 'role': 'CONTACT', 'email': 'hooman.poor@mountsinai.org', 'phone': '212-241-5656'}], 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christopher M. Harnain, MD, MBA, RPVI', 'role': 'CONTACT', 'email': 'cmh9017@med.cornell.edu', 'phone': '212.746.4635'}], 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Zakaria Assi, MD', 'role': 'CONTACT', 'email': 'zassi@buckeye-express.com', 'phone': '419-291-4438'}], 'facility': 'Promedica', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Khashayar Farsad, MD, PhD', 'role': 'CONTACT', 'email': 'farsad@ohsu.edu', 'phone': '503-494-7226'}], 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Steven Pugliese, MD', 'role': 'CONTACT', 'email': 'Steven.Pugliese@pennmedicine.upenn.edu', 'phone': '215-614-1527'}], 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Carin Gonsalves, MD', 'role': 'CONTACT', 'email': 'Carin.Gonsalves@jefferson.edu', 'phone': '215-955-6609'}], 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rabih A. Chaer, MD', 'role': 'CONTACT', 'email': 'chaerra@upmc.edu', 'phone': '412-802-3025'}], 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '19096', 'city': 'Wynnewood', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lee Greenspon, MD', 'role': 'CONTACT', 'email': 'GreensponL@MLHS.ORG', 'phone': '610-642-3796'}], 'facility': 'Main Line Healh', 'geoPoint': {'lat': 40.00289, 'lon': -75.27074}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'DaeHee Kim, MD', 'role': 'CONTACT', 'email': 'daehee_kim@brown.edu', 'phone': '401-444-5184'}], 'facility': 'Lifespan', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kevin W. Dickey', 'role': 'CONTACT', 'email': 'dickeyke@musc.edu', 'phone': '843-792-5069'}], 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bela Patel, MD', 'role': 'CONTACT', 'email': 'Bela.patel@uth.tmc.edu', 'phone': '713-500-6831'}], 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mark Dodson, MD', 'role': 'CONTACT', 'email': 'Mark.Dodson@imail.org', 'phone': '801-507-4603'}], 'facility': 'Intermountain Health', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nathan Hatton, MD', 'role': 'CONTACT', 'email': 'nathan.hatton@hsc.utah.edu', 'phone': '801-581-5811'}], 'facility': 'University of Utah Health', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Dexter, MD', 'role': 'CONTACT', 'email': 'djdexte1@sentara.com', 'phone': '757-388-5480'}], 'facility': 'Sentara Health Research Center', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '24014', 'city': 'Roanoke', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joseph A. Hughes, M.D', 'role': 'CONTACT', 'email': 'jahughes1@carilionclinic.org', 'phone': '540-981-7083'}, {'name': 'Joseph Hughes, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Carilion Clinic', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew J. Scheidt, MD', 'role': 'CONTACT', 'email': 'mscheidt@mcw.edu', 'phone': '414-805-3125'}], 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'centralContacts': [{'name': 'Sunil Rao', 'role': 'CONTACT', 'email': 'Sunil.rao@nyulangone.org', 'phone': '212-263-0456'}, {'name': 'Stephanie Boumakis', 'role': 'CONTACT', 'email': 'stephanie.mavromichalis@nyulangone.org', 'phone': '212-263-0159'}], 'overallOfficials': [{'name': 'Sunil Rao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.', 'ipdSharing': 'YES', 'description': 'The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: aks9010@med.cornell.edu.The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.', 'accessCriteria': 'The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to aks9010@med.cornell.edu. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}