[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621837":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":33,"locations":39,"responsibleParty":74,"collaborators":10,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":10,"studyType":90,"phases":10,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":98,"whyStopped":10,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Heart Input Output Inc","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"CT Angiogram",null,"This is the Cohort which received only Computed Tomography Angiography as a part of the study",[13],"Device: AI-ECG Analysis",{"label":15,"type":10,"description":16,"interventionNames":17},"Invasive Angiography","This is the Cohort which received both Computed Tomography Angiography and Invasive Angiography as a part of the study",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Enrollment Period 2","This Cohort is the continuation of enrollment of invasive angiogram patients beyond the completion of the primary endpoint",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DEVICE","AI-ECG Analysis","The AI-Analysis done on the ECGs in a retrospective fashion",[9,19,15],[29],{"name":30,"affiliation":31,"role":32},"Gary S Mintz","CardioVascular Research Foundation","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":10,"email":38},"Michael Leasure","CONTACT","6104517343","Michael.Leasure@heartio.ai",[40,58],{"facility":41,"status":10,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Medstar Washington Hospital Center","Washington D.C.","District of Columbia","20010","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-77.03637,38.89511,{"lat":51,"lon":50},[54],{"name":55,"role":36,"phone":56,"phoneExt":10,"email":57},"Hector Garcia, M.D","(202) 877-7000","Hector.M.GarciaGarcia@medstar.net",{"facility":59,"status":10,"city":60,"state":61,"zip":62,"country":45,"countryCode":46,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Cena Research Institute","Houston","Texas","77055",{"type":48,"coordinates":64},[65,66],-95.36327,29.76328,{"lat":66,"lon":65},[69,73],{"name":70,"role":36,"phone":71,"phoneExt":10,"email":72},"Asif Ali, MD","713-464-4140","drasif@hccheart.com",{"name":70,"role":32,"phone":10,"phoneExt":10,"email":10},{"type":75,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100621837","analysis-of-ecgio-to-predict-coronary-stenosis-against-a-mixed-reference-standard-100621837",false,"NCT07375810","Analysis of ECGio to Predict Coronary Stenosis Against a Mixed Reference Standard","A Study to Measure Underlying Coronary Stenosis; a Retrospective, Multi-center Study to Measure Efficacy of ECGio Against Multiple Reference Standards","SUMMER","Inclusion Criteria:\n\n1. Patients 18 years of age or older at time of data collection.\n2. Patients with medical records stored in a digitized format.\n3. Patients under suspicion of coronary artery disease (both suspicion of significant coronary artery disease as well as to rule out significant CAD) who present to the site with an electrocardiogram recorded up to 30 days prior to Coronary Computed Tomography Angiography.\n\nExclusion Criteria:\n\n1. Patients with acute coronary syndrome.\n2. Patients who previously underwent coronary artery bypass grafting.\n3. Patients whose electrocardiogram tracing has extreme noise or artifact to the extent that it would be recommended to redo the tracing.\n4. Patients with prior percutaneous coronary intervention resulting in stenting.\n5. Unanalyzable invasive coronary angiogram.\n6. Unanalyzable Coronary Computed Tomography Angiography.\n7. Unanalyzable electrocardiogram signal.\n8. Incomplete invasive coronary angiogram (e.g., only the right coronary artery was injected and visualized).\n9. Patient core lab analyzed Coronary Computed Tomography Angiography showed ≥ 50% blockage in any vessel but patient was not referred to invasive coronary angiogram.","ALL","18 Years","89 Years",{"count":88,"type":89},978,"ESTIMATED","OBSERVATIONAL","The study objective is to evaluate the effectiveness of the ECGio algorithm in predicting clinically significant coronary artery disease . ECGio's diagnostic performance during the trial will be compared against an objective performance ¬criteria using a mixed reference standard of quantitative coronary angiography and quantitative coronary computed tomography angiography in patients a general adult population under suspicion of coronary artery disease.",[93],"Coronary Artery Disease (CAD)",[95,96,97],"Artificial Intelligence","Electrocardiogram","Coronary Artery Disease","NOT_YET_RECRUITING","2026-03-25",{"date":101,"type":102},"2026-03-30","ACTUAL",{"date":104,"type":89},"2026-04-01",{"date":106,"type":89},"2026-09-01",{"name":5,"class":6},2]