Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
The Personal BP - CAI Study is a research trial designed to explore how to better set personalized blood pressure targets for patients undergoing planned heart surgery. The study aims to use a special tool called the Cerebral Adaptive Index to help doctors understand which blood pressure levels are safest for each patient, especially those at higher risk for issues related to blood flow to the brain.
To participate in this study, you need to be at least 45 years old and scheduled for cardiac surgery that involves a technique called Cardiopulmonary Bypass. You should also have a history of high blood pressure or other conditions that increase your risk for brain-related health issues, like diabetes or previous strokes. If you join, you will be monitored closely during your surgery using advanced equipment to keep track of your blood pressure. The study is currently looking for participants, and it is important that you can understand English, are not pregnant, and are not having surgery for a congenital heart defect. Your involvement could help improve how doctors manage blood pressure during surgery for future patients.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Signed informed consent
- • 2. Age ≥ 45 years
- • 3. Planned cardiac surgery with Cardiopulmonary Bypass (CPB)
- • 4. Planned monitoring with ForeSight sensor and HemoSphere monitor
- • 5. Planned arterial catheterization for blood pressure monitoring
- • 6. 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
- Exclusion Criteria:
- • 1. Non-English speaking
- • 2. Confirmed to be pregnant
- • 3. Surgery for congenital heart defect
- • 4. Non-availability of HemoSphere with laptop CAI interface
About Edwards Lifesciences
Edwards Lifesciences is a global leader in heart valve technologies and critical care monitoring, dedicated to advancing patient outcomes through innovative medical devices. With a strong focus on research and development, the company specializes in minimally invasive solutions for structural heart disease and surgical heart valve replacements. Committed to clinical excellence, Edwards Lifesciences collaborates with healthcare professionals to enhance the quality of care for patients with cardiovascular conditions, driving progress in the field through rigorous clinical trials and a robust portfolio of proprietary technologies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Evanston, Illinois, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported