Status:
TERMINATED
CONNEQT Pulse Validation Study
Lead Sponsor:
Mount Carmel Health System
Collaborating Sponsors:
AtCor Medical, Inc.
Conditions:
Pregnancy Related
Pre-Eclampsia
Eligibility:
FEMALE
18+ years
Brief Summary
The purpose of this study is to validate the accuracy of the CONNEQT Pulse blood pressure monitoring system for the measurement of blood pressure as compared to a gold standard, auscultatory sphygmoma...
Detailed Description
Clinical staff will review patient's medical record to determine eligibility. Following informed consent, a brief medical history will be collected. Serial blood pressure measurements will be collecte...
Eligibility Criteria
Inclusion
- All Groups:
- Able to provide informed consent
- Pregnant patient, beyond the first trimester (greater than 12 weeks of gestation)
- 18 years of age, or older
- Normotensive:
- 1\. Systolic blood pressure \<140 mmHg (18,66 kPa) and diastolic blood pressure \<90 mmHg (12 kPa)
- Hypertensive:
- Without proteinuria \>300 mg in 24 h; and
- With systolic blood pressure ≥140 mmHg (18,66 kPa) or diastolic blood pressure ≥ 90 mmHg (12 kPa)
- Pre-Eclampsia:
- With proteinuria \>300 mg in 24 h; and
- With systolic blood pressure ≥140 mmHg (18,66 kPa) or diastolic blood pressure ≥ 90 mmHg (12,00 kPa)
Exclusion
Key Trial Info
Start Date :
August 21 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 3 2025
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT06002971
Start Date
August 21 2023
End Date
June 3 2025
Last Update
June 25 2025
Active Locations (1)
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1
Mount Carmel East
Columbus, Ohio, United States, 43213