N/A N=37

Clinical Calibration & Validation of a Next-Generation Blood Pressure Monitor for Patient Management

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT03015363 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2021

Primary outcome: Primary: Systolic Pressure — 133.4 mmHg

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: Cardiovascular Research New Brunswick
Primary completion: May 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Systolic Pressure	145.7	—
PRIMARY Diastolic Pressure	66.2	—
PRIMARY Systolic Pressure	145.7	—
PRIMARY Diastolic Pressure	66.2	—

Summary

The objective of the Cloud DX Pulsewave Health Monitor study is to prospectively calibrate and validate a novel, non-invasive wrist cuff blood pressure device against the gold standard for hemodynamic monitoring (intra-arterial pressure) in voluntarily consented patient participants who are scheduled for an elective cardiac catheterization procedure for clinically valid reasons.

Eligibility Criteria

Inclusion Criteria

≥ 19 years of age
Patients recommended by their cardiologist for a first-time, elective cardiac catheterization procedure
Wrist circumference between 13.5cm - 23cm (5.3 - 9.1in.)
Bilateral arm blood pressure equality (systolic within ±10mmHg; diastolic within ±5mmHg) on 2 separate readings (Nurse Associate & TRA)
Willing to volunteer to participate and to sign the study specific informed consent form

Exclusion Criteria

No history of peripheral vascular disease, no previous percutaneous coronary intervention, nor previous coronary artery bypass graft
No arrhythmia
No abdominal aortic aneurysm
No hand/body tremor

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03015363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.