[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06399705":3,"trial-entities:NCT06399705":219,"trial-summary:NCT06399705":222},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":48,"secondary_outcomes":53,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":60,"eligibility_criteria":61,"std_ages":65,"locations":68,"central_contacts":197,"overall_officials":205,"references":210,"see_also_links":218},"NCT06399705","23-11026800 - 2","REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Minorities","RECRUITING","2039-01-01","2025-09","2025-10-01","2024-10-02","Weill Medical College of Cornell University","OTHER",true,"This is a research study in minorities to compare the outcomes of two procedures that restore blood flow to the arteries of the heart. In one procedure the blockages are ballooned and then stented with a small wire mesh tube through a small incision in the wrist or the groin. The other procedure is an open-heart operation in which healthy blood vessels from inside the chest, leg, and\u002For forearm are used to \"bypass\" the blockages (like a detour). Outcomes will be measured by comparing survival and improvement in quality-of-life.","The RECHARGE: Minorities Trial is a multicenter, 1:1 randomized, open-label superiority trial.\n\nPatients meeting the eligibility criteria for whom there is equipoise for revascularization with CABG and PCI, as determined by the local Heart Team, will be included. Participants will be followed for 5-10 years. Telephone follow-up will be conducted by the a central follow-up coordinating center at 30 days, 3 months, 6 months, and thereafter every 6 months through 36 months post-randomization. After 36 months, follow-up will be performed every year (48, 60, 72, 84, 96, 108, 120 months). A repeat transthoracic echocardiogram and blood draw for serum creatinine, hemoglobin and lipids should be performed at 1 year, as per standard of care, at either an out-patient facility or in a hospital.",[18],"Coronary Artery Disease",[20,21,22,23,24],"RECHARGE","Cardiac Surgery","Minority","percutaneous coronary intervention","Quality of Life","INTERVENTIONAL","PREVENTION",[28],"PHASE3",{"count":30,"type":31},600,"ESTIMATED",[33,41],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":39},"PROCEDURE","Coronary artery bypass grafting","Coronary artery bypass grafting (CABG), also called heart bypass surgery, is a medical procedure to improve blood flow to the heart.",[38],"RECHARGE: Minorities - CABG",[40],"CABG",{"type":34,"name":42,"description":43,"armGroupLabels":44,"otherNames":46},"Percutaneous coronary intervention","Percutaneous coronary intervention (PCI) is a non-surgical procedure used to treat the blockages in a coronary artery; it opens up narrowed or blocked sections of the artery, restoring blood flow to the heart",[45],"RECHARGE: Minorities - PCI",[47],"PCI",[49],{"measure":50,"description":51,"timeFrame":52},"Hierarchical composite of all-cause death and time-averaged change from baseline in generic quality of life using the SF-12v2","Generic quality of life (QOL) will be assessed by utilizing the 12-item Short Form Survey (SF-12v2). The score ranges from 1-100, with higher scores indicating a better health status. The win ratio will be used","5 years",[54],{"measure":55,"description":56,"timeFrame":52},"Time averaged change from baseline in disease-specific quality of life using the SAQ-OS","Disease-specific quality of life (QOL) will be assessed by utilizing the Seattle Angina Questionnaire overall summary (SAQ-OS) score. The score ranges from 1-100, with higher scores indicating a better health status.","ALL","18 Years",null,false,{"inclusion":62,"exclusion":63,"raw_text":64},[],[],"Inclusion Criteria:\n\n1. Patient must identify as a minority\n2. Patient is at least 18 years old.\n3. Multivessel or left main CAD is present for which revascularization is intended and for which there is equipoise between CABG and PCI according to local Heart Team assessment.\n4. Ability to provide written informed consent and comply with all follow-up procedures, including QOL questionnaires.\n\nExclusion Criteria:\n\n1. ST-segment elevation MI within 3 days\n2. Cardiogenic shock\n3. Prior PCI within 1 year or any prior CABG anytime\n4. Planned hybrid revascularization (PCI after CABG or CABG after PCI)\n5. Planned single vessel revascularization (other than isolated left main disease)\n6. Need for any cardiac surgical or interventional procedure other than coronary revascularization at the present time or anticipated within 3 years\n7. Pregnancy (women of child-bearing potential must have a negative pregnancy test within 1 week before randomization) or intent to become pregnant within 1 year after randomization Unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 3 months if presentation with stable CAD or 6 months if presentation with a troponin-positive acute coronary syndrome Current participation in another investigational drug or device study that has not reached its primary endpoint Life-expectancy less than 3 years due to concomitant non-cardiac conditions Any condition(s) are present that are likely to interfere with the study protocol procedures including medication adherence and follow-up through 10 years (e.g. mental disability, substance abuse, anticipated international relocation, etc.)",[66,67],"ADULT","OLDER_ADULT",[69,78,86,94,102,109,117,125,133,139,143,147,151,158,166,174,182,189],{"facility":70,"status":7,"city":71,"state":72,"zip":73,"country":74,"geoPoint":75},"Adventist Health Glendale","Glendale","California","91206","United States",{"lat":76,"lon":77},34.14251,-118.25508,{"facility":79,"status":7,"city":80,"state":81,"zip":82,"country":74,"geoPoint":83},"Emory University","Atlanta","Georgia","30322",{"lat":84,"lon":85},33.749,-84.38798,{"facility":87,"status":7,"city":88,"state":89,"zip":90,"country":74,"geoPoint":91},"Ascension St. Vincent Cardiovascular Research Institute","Carmel","Indiana","46290",{"lat":92,"lon":93},39.97837,-86.11804,{"facility":95,"status":7,"city":96,"state":97,"zip":98,"country":74,"geoPoint":99},"Baptist Health Lexington","Lexington","Kentucky","40503",{"lat":100,"lon":101},37.98869,-84.47772,{"facility":103,"status":7,"city":104,"state":97,"zip":105,"country":74,"geoPoint":106},"Baptist Health Louisville","Louisville","40207",{"lat":107,"lon":108},38.25424,-85.75941,{"facility":110,"status":7,"city":111,"state":112,"zip":113,"country":74,"geoPoint":114},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"lat":115,"lon":116},42.35843,-71.05977,{"facility":118,"status":7,"city":119,"state":120,"zip":121,"country":74,"geoPoint":122},"Englewood Hospital","Englewood","New Jersey","07631",{"lat":123,"lon":124},40.89288,-73.97264,{"facility":126,"status":7,"city":127,"state":128,"zip":129,"country":74,"geoPoint":130},"NewYork-Presbyterian Hospital - Queens","Flushing","New York","11355",{"lat":131,"lon":132},40.76538,-73.81736,{"facility":134,"status":7,"city":128,"state":128,"zip":135,"country":74,"geoPoint":136},"Icahn School of Medicine - Mount Sinai Morningside","10025",{"lat":137,"lon":138},40.71427,-74.00597,{"facility":140,"status":7,"city":128,"state":128,"zip":141,"country":74,"geoPoint":142},"Icahn School of Medicine - Mount Sinai Hospital","10029",{"lat":137,"lon":138},{"facility":144,"status":7,"city":128,"state":128,"zip":145,"country":74,"geoPoint":146},"Columbia University Irving Medical Center\u002FNewYork-Presbyterian Hospital","10032",{"lat":137,"lon":138},{"facility":148,"status":7,"city":128,"state":128,"zip":149,"country":74,"geoPoint":150},"Weill Cornell Medicine\u002FNewYork-Presbyterian Hospital","10065",{"lat":137,"lon":138},{"facility":152,"status":7,"city":153,"state":128,"zip":154,"country":74,"geoPoint":155},"Westchester Medical Center","Valhalla","10595",{"lat":156,"lon":157},41.07482,-73.77513,{"facility":159,"status":7,"city":160,"state":161,"zip":162,"country":74,"geoPoint":163},"Duke University","Durham","North Carolina","27710",{"lat":164,"lon":165},35.99403,-78.89862,{"facility":167,"status":7,"city":168,"state":169,"zip":170,"country":74,"geoPoint":171},"Ohio State University","Columbus","Ohio","43210",{"lat":172,"lon":173},39.96118,-82.99879,{"facility":175,"status":7,"city":176,"state":177,"zip":178,"country":74,"geoPoint":179},"Methodist Le Bonheur Healthcare","Memphis","Tennessee","38104",{"lat":180,"lon":181},35.14953,-90.04898,{"facility":183,"status":7,"city":184,"state":177,"zip":185,"country":74,"geoPoint":186},"Ascension Saint Thomas Hospital","Nashville","37205",{"lat":187,"lon":188},36.16589,-86.78444,{"facility":190,"status":7,"city":191,"state":192,"zip":193,"country":74,"geoPoint":194},"Baylor Scott and White","Dallas","Texas","75246",{"lat":195,"lon":196},32.78306,-96.80667,[198,203],{"name":199,"role":200,"phone":201,"email":202},"Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC","CONTACT","Gregg.Stone@mountsinai.org","mfg9004@med.cornell.edu",{"name":204,"role":200,"email":201},"Gregg Stone, MD, FACC, MSCAI",[206,208],{"name":199,"affiliation":12,"role":207},"PRINCIPAL_INVESTIGATOR",{"name":204,"affiliation":209,"role":207},"Icahn School of Medicine at Mount Sinai",[211,215],{"pmid":212,"type":213,"citation":214},"42323001","DERIVED","Gaudino M, Stone GW, Puskas J, Krieger K, Redfors B, Bagiella E, Gelijns A, Bhatt DL, Sandner S, Barman N, Bozinovski J, Gee P, Haider A, Hafiz AM, Jolly SS, Li D, Mack C, Madani MM, Mahmud E, Pineda AM, Masoudi FA, Mazzaferri E, Monroe R, Nicholson W, Pocock SJ, Sachdeva R, Yong C, Zwischenberger BA, Yancy C, Creber RM, Spertus J. Lessons learned from the feasibility phase of the REvascularization CHoices Among Under-Represented Groups Evaluation (RECHARGE) trial program. Am Heart J. 2026 Jun 20;301:107515. doi: 10.1016\u002Fj.ahj.2026.107515. Online ahead of print.",{"pmid":216,"type":213,"citation":217},"42283075","Nino de Rivera S, Suero-Tejeda NM, Monroe R, Tang M, Eslami S, Sallam A, Gee PO, Redfors B, Yancy CW, Gaudino MFL, Stone GW, Spertus JA, Masterson Creber RM. Patient Perspectives in Cardiovascular Research: A Qualitative Study of Barriers, Trust, and Strategies for Inclusive Clinical Trials. Circ Popul Health Outcomes. 2026 Jul;19(7):e012189. doi: 10.1161\u002FCIRCOUTCOMES.125.012189. Epub 2026 Jun 12.",[],{"nct_id":4,"conditions":220,"biomarkers":221},[18],[],{"nct_id":4,"found":14,"summary":223,"prompt_version":233},{"design":224,"status":225,"heading":226,"summary":227,"follow_up":228,"word_count":229,"commitments":230,"compensation":231,"drugs_mentioned":232},"This is a randomized, open-label study where participants are randomly assigned to one of two treatment groups. It aims to enroll 600 participants.","completed","RECHARGE Trial: Comparing Heart Procedures for Coronary Artery Disease in Minorities","This study, called RECHARGE: Minorities, is for people with coronary artery disease (blocked heart arteries) who identify as a minority. It compares two ways to restore blood flow to the heart: coronary artery bypass grafting (CABG), which is open-heart surgery, and percutaneous coronary intervention (PCI), a non-surgical procedure using a balloon and stent. Doctors will decide if either procedure is equally suitable for you. The study aims to see which treatment leads to better survival and quality of life over 5 years. We are looking to enroll 600 participants, but the current recruitment status is unclear.","Participants will be followed for 5 to 10 years after their treatment.",96,"You would have follow-up phone calls at 30 days, 3, 6, 12, 18, 24, 30, and 36 months, then yearly for up to 10 years. You will also have a repeat echocardiogram and blood tests at 1 year.","Not stated in the trial record.",[35,42],"v2"]