[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06178744":3,"trial-entities:NCT06178744":76,"trial-summary:NCT06178744":80},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":17,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":27,"secondary_outcomes":32,"sex":33,"minimum_age":34,"maximum_age":17,"healthy_volunteers":17,"eligibility_criteria":35,"std_ages":41,"locations":44,"central_contacts":66,"overall_officials":72,"references":74,"see_also_links":75},"NCT06178744","23-006378","A Study of AI in Cardiac Transplant in Echocardiographic Analysis (ORACLE)","Outcome Reflection for Immune Mediated Rejection by Utilizing Artificial Intelligence in Cardiac Transplant Patients Through Early and Late Echocardiographic Analysis (ORACLE)","RECRUITING","2028-06","2026-06","2026-06-24","2024-04-04","Mayo Clinic","OTHER",false,"The purpose of this research is to detect episodes of rejection versus non-rejection after cardiac transplant and the diagnostic accuracy of an Artificial Intelligence (AI) algorithm using the data from an ECG (electrocardiogram) and Cardiac Ultrasound (Echocardiogram and\u002For point of care ultrasound).",null,[19],"Cardiac Transplant Rejection",[],"OBSERVATIONAL",[],{"count":24,"type":25},500,"ESTIMATED",[],[28],{"measure":29,"description":30,"timeFrame":31},"Number of episodes identified by the Artificial Intelligence (AI) algorithm as 1R or greater acute cellular rejection, grade 1 or greater antibody mediated rejection, reduction in LVEF to \u003C50%, or a drop in LVEF >5%","Number of episodes identified by the AI algorithm as 1R or greater acute cellular rejection, grade 1 or greater antibody mediated rejection, reduction in LVEF to \\\u003C50%, or a drop in LVEF \\>5% utilizing electrocardiograms and cardiac ultrasound images\u002Fvideos obtained from point of care ultrasound (POCUS) or echocardiograms.","2 years",[],"ALL","18 Years",{"inclusion":36,"exclusion":38,"raw_text":40},[37],"Patients undergoing post-cardiac transplant endomyocardial biopsy, and the ability to provide informed consent and a consent for the study.",[39],"Refusal of study participation","Inclusion Criteria:\n\n* Patients undergoing post-cardiac transplant endomyocardial biopsy, and the ability to provide informed consent and a consent for the study.\n\nExclusion Criteria:\n\n* Refusal of study participation",[42,43],"ADULT","OLDER_ADULT",[45],{"facility":46,"status":8,"city":47,"state":48,"zip":49,"country":50,"contacts":51,"geoPoint":63},"Mayo Clinic in Rochester","Rochester","Minnesota","55905","United States",[52,57,61],{"name":53,"role":54,"phone":55,"email":56},"Ellie Thein","CONTACT","(507) 266-6519","Thein.Ellie@mayo.edu",{"name":58,"role":54,"phone":59,"email":60},"Atta Behfar, MD, PhD","507-266-0318","Behfar.Atta@mayo.edu",{"name":58,"role":62},"PRINCIPAL_INVESTIGATOR",{"lat":64,"lon":65},44.02163,-92.4699,[67,71],{"name":68,"role":54,"phone":69,"email":70},"Alyssa Lokensgard","507-422-5123","lokensgard.alyssa@mayo.edu",{"name":58,"role":54,"phone":59,"email":60},[73],{"name":58,"affiliation":13,"role":62},[],[],{"nct_id":4,"conditions":77,"biomarkers":79},[78],"Cardiac transplant rejection",[],{"nct_id":4,"found":81,"summary":82,"prompt_version":92},true,{"design":83,"status":84,"heading":85,"summary":86,"follow_up":87,"word_count":88,"commitments":89,"compensation":90,"drugs_mentioned":91},"This is an observational study with a planned enrollment of 500 participants. It is not specified if it is a specific phase of research.","completed","AI in Cardiac Transplant Echocardiographic Analysis (ORACLE)","This study, called ORACLE, is looking at how well Artificial Intelligence (AI) can help detect rejection after a heart transplant. Researchers are using AI to analyze data from your electrocardiogram (ECG, a test that checks your heart's electrical activity) and cardiac ultrasound (echocardiogram, a test that uses sound waves to create images of your heart). The goal is to see if the AI can accurately identify episodes of rejection, such as acute cellular rejection or antibody-mediated rejection, or a significant drop in your heart's pumping ability. You may be able to join if you are 18 or older, have had a heart transplant, and are undergoing a post-transplant endomyocardial biopsy (a procedure to take a small tissue sample from your heart). The study aims to enroll 500 participants.","The primary endpoint measures are assessed at 2 years.",128,"You would need to be undergoing a post-cardiac transplant endomyocardial biopsy and provide informed consent for the study.","Not stated in the trial record.",[],"v2"]