[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553950":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":20,"interventions":26,"overallOfficials":13,"centralContacts":32,"locations":38,"responsibleParty":56,"collaborators":13,"id":58,"slug":13,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":13,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":13,"enrollmentInfo":66,"targetDuration":13,"studyType":69,"phases":70,"briefSummary":71,"conditions":72,"keywords":13,"overallStatus":41,"whyStopped":13,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Edwards Lifesciences","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"To determine the magnitude and duration of CAI","To determine the sum of the product of magnitude and duration that CAI during cardiopulmonary bypass (CPB) is at or above the threshold of 45 during current standard of care and assess the incidence of CAI ≥45 in the absence of decreased cerebral StO2 or MAP thresholds.","Duration of the procedure through 30 days",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","OTHER",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE",[21],{"label":22,"type":23,"description":13,"interventionNames":24},"Cardiopulmonary bypass patients receiving blood pressure and oximetry monitoring","EXPERIMENTAL",[25],"Device: HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":13},"DEVICE","HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring","The arterial line with Acumen IQ sensor and Foresight Elite sensor will be connected to the HemoSphere monitor with laptop displaying the CAI parameter.",[22],[33],{"name":34,"role":35,"phone":36,"phoneExt":13,"email":37},"Cristina Johnson","CONTACT","888-713-1564","cc_clinical_affairs@edwards.com",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Northwestern University Hospital","RECRUITING","Evanston","Illinois","60611","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-87.69006,42.04114,{"lat":51,"lon":50},[54],{"name":55,"role":35,"phone":13,"phoneExt":13,"email":13},"Bin Zhang",{"type":57,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100553950",false,"NCT06492746","Personal BP - CAI Study","Assessing for Personalized Blood Pressure Targets During Cardiopulmonary Bypass With the Proprietary Cerebral Adaptive Index: A Pilot Investigation","Inclusion Criteria:\n\n1. Signed informed consent\n2. Age ≥ 45 years\n3. Planned cardiac surgery with Cardiopulmonary Bypass (CPB)\n4. Planned monitoring with ForeSight sensor and HemoSphere monitor\n5. Planned arterial catheterization for blood pressure monitoring\n6. High risk for cerebral vascular disease, defined as: a history of hypertension, pulse pressure \\> 60 mmHg, diabetes, stroke, transient ischemic attack, carotid bruit, tobacco smoking, or peripheral vascular disease\n\nExclusion Criteria:\n\n1. Non-English speaking\n2. Confirmed to be pregnant\n3. Surgery for congenital heart defect\n4. Non-availability of HemoSphere with laptop CAI interface","ALL","45 Years",{"count":67,"type":68},120,"ESTIMATED","INTERVENTIONAL",[15],"A single-center, prospective, observational pilot of the Cerebral Adaptive Index for assessing personalized blood pressure targets",[73],"Blood Pressure","2025-07-09",{"date":76,"type":77},"2025-07-14","ACTUAL",{"date":79,"type":77},"2024-06-03",{"date":81,"type":68},"2025-12",{"name":5,"class":6},1]