An observational study in Hypertension, sponsored by Cardiovascular Research New Brunswick. Completed at 1 site in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-08-30.
Sponsored by Cardiovascular Research New Brunswick · Observational
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.
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 20 is below the median of 210 across 1,359 observational studies indexed under Hypertension.
Browse Hypertension studies →Cardiovascular Research New Brunswick is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients scheduled for an elective, non-emergent cardiac catheterization with right radial access; exclusion criteria being no history of peripheral vascular disease, no previous coronary artery bypass graft, no precious percutaneous coronary intervention, abdominal aortic aneurysm, arrhythmia, hand/body tremor, nor bilateral arm pressure inequality during history and physical.
Exclusion Criteria:
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.
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.
Systolic Pressure
Peripheral arterial pressure (mm Hg)
Time frame: Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.
Diastolic Pressure
Peripheral arterial pressure (mm Hg)
Time frame: Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.
| Milestone | Prospective Cohort (1) |
|---|---|
| Started | 37 |
| Completed | 20 |
| Not completed | 17 |
| Withdrew: Physician decision | 14 |
| Withdrew: Withdrawal by subject | 3 |
Central aortic pressure (mmHg)
| mmHg | Prospective Cohort (1) |
|---|---|
| Systolic Pressure | 133.4 ± 22.0 |
Central aortic pressure (mm Hg)
| mmHg | Prospective Cohort (1) |
|---|---|
| Diastolic Pressure | 67.4 ± 8.7 |
Peripheral arterial pressure (mm Hg)
| mmHg | Prospective Cohort (1) |
|---|---|
| Systolic Pressure | 145.7 ± 20.2 |
Peripheral arterial pressure (mm Hg)
| mmHg | Prospective Cohort (1) |
|---|---|
| Diastolic Pressure | 66.2 ± 9.1 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prospective Cohort (1) | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Prospective Cohort (1) |
|---|---|
| Mean | 62.0 ± 9.0 |
| Sex: Female, Male(Participants) | Prospective Cohort (1) |
|---|---|
| Female | 5 |
| Male | 15 |
| Race and Ethnicity Not Collected(Participants) | Prospective Cohort (1) |
|---|
| Region of Enrollment(participants) | Prospective Cohort (1) |
|---|---|
| Canada | 20 |
| Smoking (%)(Participants) | Prospective Cohort (1) |
|---|---|
| Count of participants | 3 |
| Diabetes (%)(Participants) | Prospective Cohort (1) |
|---|---|
| Count of participants | 7 |
| Dyslipidemia (%)(Participants) | Prospective Cohort (1) |
|---|---|
| Count of participants | 14 |
| Hypertension (%)(Participants) | Prospective Cohort (1) |
|---|---|
| Count of participants | 15 |
Plan to share: Undecided
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Cardiovascular Research New Brunswick