Hypertension
Conditions
Keywords
Hypertension, Telemonitoring, Vital signs
Brief 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.
Detailed description
The Cloud DX Pulsewave Health Monitor is a non-invasive wrist cuff blood pressure device that is licensed by Health Canada with Food and Drug Administration approval. Systolic and diastolic pressures are measured via the arterial pulse waveform of the left radial artery. Initially, the blood pressure algorithm was created and calibrated using the auscultatory method. The purpose of this study is to calibrate the device to the clinical gold standard of peripheral and central intra-arterial pressures. The device acquires a pulse signal in real-time, stores signal and measurement data, and displays stored signal and measurement data for interpretation via internet servers where it is accessible by end-users (physicians and/or patients). The system provides secure accounts for both in-patient and out-patient monitoring. Cloud DX's Pulsewave Health Monitor servers are housed in a secure data center. Privacy measures are to SSAE16 SOC-1 Type-II compliance: 1) restricted secure access, 2) dedicated firewall, 3) HTTPS channel communication via website, 4) self-encrypting hard-drives rendered useless if removed from the server.
Interventions
None listed
Sponsors
Horizon Health Network
Dalhousie University
Cloud DX Inc.
New Brunswick Health Research Foundation
Cardiovascular Research New Brunswick
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Pressure | Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure. | Central aortic pressure (mmHg) |
| Diastolic Pressure | Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure. | Central aortic pressure (mm Hg) |
Countries
Canada
Participant flow
Pre-assignment details
A total of 37 eligible patients voluntarily consented to participate in the study, although 3 participants withdrew and 14 participants failed to meet the study eligibility criteria.
Participants by arm
| Arm | Count |
|---|---|
| Prospective Cohort (1) Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 14 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Prospective Cohort (1) | — |
|---|---|---|
| Age, Continuous | 62.0 years STANDARD_DEVIATION 9 | — |
| Diabetes (%) | 7 Participants | — |
| Dyslipidemia (%) | 14 Participants | — |
| Hypertension (%) | 15 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 20 participants | — |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 15 Participants | — |
| Smoking (%) | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Diastolic Pressure
Peripheral arterial pressure (mm Hg)
Time frame: Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.
Population: Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prospective Cohort (1) | Diastolic Pressure | 66.2 mmHg | Standard Deviation 9.1 |
Primary
Diastolic Pressure
Central aortic pressure (mm Hg)
Time frame: Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure.
Population: Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prospective Cohort (1) | Diastolic Pressure | 67.4 mmHg | Standard Deviation 8.7 |
Primary
Systolic Pressure
Peripheral arterial pressure (mm Hg)
Time frame: Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.
Population: Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prospective Cohort (1) | Systolic Pressure | 145.7 mmHg | Standard Deviation 20.2 |
Primary
Systolic Pressure
Central aortic pressure (mmHg)
Time frame: Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure.
Population: Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prospective Cohort (1) | Systolic Pressure | 133.4 mmHg | Standard Deviation 22 |