Status:

RECRUITING

Personal BP - CAI Study

Lead Sponsor:

Edwards Lifesciences

Conditions:

Blood Pressure

Eligibility:

All Genders

45+ years

Phase:

NA

Brief Summary

A single-center, prospective, observational pilot of the Cerebral Adaptive Index for assessing personalized blood pressure targets

Eligibility Criteria

Inclusion

  • Signed informed consent
  • Age ≥ 45 years
  • Planned cardiac surgery with Cardiopulmonary Bypass (CPB)
  • Planned monitoring with ForeSight sensor and HemoSphere monitor
  • Planned arterial catheterization for blood pressure monitoring
  • 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

  • Non-English speaking
  • Confirmed to be pregnant
  • Surgery for congenital heart defect
  • Non-availability of HemoSphere with laptop CAI interface

Key Trial Info

Start Date :

June 3 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT06492746

Start Date

June 3 2024

End Date

December 1 2025

Last Update

July 14 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Northwestern University Hospital

Evanston, Illinois, United States, 60611