HypertensionCCVNCT03015363
Clinical Calibration & Validation of a Next-Generation Blood Pressure Monitor for Patient Management
An observational study of Hypertension, run by Cardiovascular Research New Brunswick at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Dec 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison, Calibration, and Validation of the Non-invasive Cloud DX Pulsewave Health MonitorTM With Direct Invasive Radial and Central Arterial Measurements During Cardiac Catheterization
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.
Read the 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.
- Conditions
- Hypertension
- Keywords
- Hypertension, Telemonitoring, Vital signs
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Pressure
Central aortic pressure (mmHg)
Measured: 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)
Measured: 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)
Measured: Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.
Diastolic Pressure
Peripheral arterial pressure (mm Hg)
Measured: Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startNov 2013
- Primary completionMay 2016
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiovascular Research New Brunswick
- Sponsor type
- University, hospital or other
- Collaborators
- Horizon Health Network, Dalhousie University, Cloud DX Inc., New Brunswick Health Research Foundation
- Responsible party
- Principal investigator, Sohrab Lutchmedial, MD, FRCPC, Cardiovascular Research New Brunswick
- Investigators
- Sohrab Lutchmedial, MD, FRCPC, Principal investigator, Cardiovascular Research New Brunswick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015363
- Sponsor's protocol ID
- RS#: 2013-1919
- Acronym
- CCV
- Status last verified
- Aug 2021
- First submitted
- 5 Jan 2017
- Last updated
- 30 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Melville S, Teskey R, Philip S, Simpson JA, Lutchmedial S, Brunt KR. A Comparison and Calibration of a Wrist-Worn Blood Pressure Monitor for Patient Management: Assessing the Reliability of Innovative Blood Pressure Devices. J Med Internet Res. 2018 Apr 25;20(4):e111. doi: 10.2196/jmir.8009.
PubMed 29695375
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison, Calibration, and Validation of the Non-invasive Cloud DX Pulsewave Health MonitorTM With Direct Invasive Radial and Central Arterial Measurements During Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT03015363
- Acronym / sponsor ID
- CCV / RS#: 2013-1919
- Conditions
- Hypertension
- Keywords
- Hypertension, Telemonitoring, Vital signs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cardiovascular Research New BrunswickUniversity, hospital or other
- Collaborators
- Horizon Health Network, Dalhousie University, Cloud DX Inc., New Brunswick Health Research Foundation
- Study start
- Nov 2013
- Primary completion
- May 2016 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Posted 30 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- ≥ 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Systolic Pressure
Time frame: 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
Time frame: 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)
Systolic Pressure
Time frame: Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.
Peripheral arterial pressure (mm Hg)
Diastolic Pressure
Time frame: Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.
Peripheral arterial pressure (mm Hg)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29695375Melville S, Teskey R, Philip S, Simpson JA, Lutchmedial S, Brunt KR. A Comparison and Calibration of a Wrist-Worn Blood Pressure Monitor for Patient Management: Assessing the Reliability of Innovative Blood Pressure Devices. J Med Internet Res. 2018 Apr 25;20(4):e111. doi: 10.2196/jmir.8009.
- Device company websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sohrab Lutchmedial, MD, FRCPC principal investigator
Cardiovascular Research New Brunswick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Cardiovascular Research New Brunswick at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Pressure (time frame: Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03015363, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.