[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06655779":3,"trial-entities:NCT06655779":78,"trial-summary:NCT06655779":82},{"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":20,"study_type":22,"primary_purpose":16,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":32,"secondary_outcomes":37,"sex":38,"minimum_age":39,"maximum_age":16,"healthy_volunteers":40,"eligibility_criteria":41,"std_ages":45,"locations":48,"central_contacts":69,"overall_officials":72,"references":76,"see_also_links":77},"NCT06655779","Integrisbmc","Performance of the Acoustic Based CADScor System in Coronary Artery Disease","NOT_YET_RECRUITING","2026-03","2024-10","2024-10-23","2024-11","INTEGRIS Baptist Medical Center","OTHER",false,"The purpose of this study is to determine if the CAD Score, collected from the CADscore system, performs as well as the Coronary CTA in determining Coronary Artery Disease, in low to intermediate risk patients that are referred for coronary CTA.",null,[18,19],"Coronary Artery Disease","Angina (stable)",[21],"CADScore","OBSERVATIONAL",[],{"count":25,"type":26},200,"ESTIMATED",[28],{"type":29,"name":30,"description":31},"DIAGNOSTIC_TEST","Acoustic Detection of Blood Flow","Subject will have the acoustic device scoring performed prior to a Coronary CTA. No treatment decisions will be based upon the acoustic device score.",[33],{"measure":34,"description":35,"timeFrame":36},"Primary Objective","To determine that the sensitivity of the CAD score in low to intermediate-risk patients referred for coronary CTA in non-inferior to the device specified sensitivity at 89%.","From enrollment through 1 year",[],"ALL","30 Years",true,{"inclusion":42,"exclusion":43,"raw_text":44},[],[],"Inclusion:\n\n* Signed ICF\n* Male or female, aged 30 years or above\n* Symptoms suggestive of stable coronary artery disease\n* No history of coronary artery disease(prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft).\n\nExclusion:\n\n* Asymptomatic for angina or chest pain\n* Implanted donor heart\n* Previous Coronary Artery Bypass Graft(CABG)\n* Previous Coronary Stenting or known CAD\n* Arrhythmia causing non-sinus rhythm\n* Fragile or compromised skin, or abnormal anatomy or significant operation scars in the fourth left int3er Costal 9IC4-L) recording area\n* Implanted mechanical heart or mechanical heart pump\n* Implanted pacemaker or Cardioverter Defibrillator(ICD), other implanted active electronics or act5ive electronic support equipment closer than 50 cm to the CADScore System.",[46,47],"ADULT","OLDER_ADULT",[49],{"facility":12,"city":50,"state":51,"zip":52,"country":53,"contacts":54,"geoPoint":66},"Oklahoma City","Oklahoma","73112","United States",[55,60,64],{"name":56,"role":57,"phone":58,"email":59},"Jill Fife, RN","CONTACT","405-951-8607","bethany.fife@integrishealth.org",{"name":61,"role":57,"phone":62,"email":63},"Linda Pitchford, RN, APRN","405-949-3648","linda.pitchford@integrishealth.org",{"name":65,"role":57},"Jon p Blaschke, MD",{"lat":67,"lon":68},35.46756,-97.51643,[70,71],{"name":56,"role":57,"phone":58,"email":59},{"name":61,"role":57,"phone":62,"email":63},[73],{"name":74,"affiliation":12,"role":75},"Jon P Blaschke, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":79,"biomarkers":81},[80,18],"Angina",[],{"nct_id":4,"found":40,"summary":83,"prompt_version":93},{"design":84,"status":85,"heading":86,"summary":87,"follow_up":88,"word_count":89,"commitments":90,"compensation":91,"drugs_mentioned":92},"This is an observational study planning to enroll 200 participants. It is designed to compare a new diagnostic test to a standard one.","completed","Observational Study of the CADScor System for Coronary Artery Disease","This study is looking at how well a device called the CADScor System performs in detecting Coronary Artery Disease (CAD), a condition where blood vessels supplying the heart become narrowed. The study will compare the results from the Acoustic Detection of Blood Flow using the CADScor System to those from a Coronary CTA (Computed Tomography Angiography), a special X-ray test. You may be able to join if you are 30 years or older, have symptoms that suggest stable angina (chest pain or discomfort due to CAD), and have no prior history of heart attack or procedures like stents or bypass surgery. The main goal is to see how well the CADScor System works over one year. The study is currently unclear on its recruitment status.","Participants will be followed from enrollment through 1 year.",125,"You will have the acoustic device scoring performed before a Coronary CTA. No treatment decisions will be based on the acoustic device score.","Not stated in the trial record.",[30],"v2"]