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

• Sponsor: Cardiovascular Research New Brunswick (Other)
• Overall Status: Completed
• CT.gov ID: NCT03015363
• Collaborator: Horizon Health Network (Other), Dalhousie University (Other), Cloud DX Inc. (Industry), New Brunswick Health Research Foundation (Other)
• Enrollment: 20
• Location: 1
• Duration (Months): 61
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension

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

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: Dec 1, 2018

Outcome Measures

Primary Outcome Measures

1. 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)

2. 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)

3. Systolic Pressure [Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.]

   Peripheral arterial pressure (mm Hg)

4. Diastolic Pressure [Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.]

   Peripheral arterial pressure (mm Hg)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Horizon Health Network	Saint John	New Brunswick	Canada

Sponsors and Collaborators

• Cardiovascular Research New Brunswick
• Horizon Health Network
• Dalhousie University
• Cloud DX Inc.
• New Brunswick Health Research Foundation

Investigators

• Principal Investigator: Sohrab Lutchmedial, MD, FRCPC, Cardiovascular Research New Brunswick

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Device company website

Publications

None provided.

• Responsible Party: Sohrab Lutchmedial, MD, FRCPC, Co-Director of CVR-NB/ Director of NBHC Catheterization Laboratory, Cardiovascular Research New Brunswick
• ClinicalTrials.gov Identifier: NCT03015363
• Other Study ID Numbers: RS#: 2013-1919
• First Posted: Jan 10, 2017
• Last Update Posted: Aug 30, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Sohrab Lutchmedial, MD, FRCPC, Co-Director of CVR-NB/ Director of NBHC Catheterization Laboratory, Cardiovascular Research New Brunswick: Hypertension; Telemonitoring; Vital signs
• Additional relevant MeSH terms: Hypertension

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Prospective Cohort (1)
Arm/Group Description	Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.
Period Title: Overall Study
STARTED	37
COMPLETED	20
NOT COMPLETED	17

Baseline Characteristics

Arm/Group Title	Prospective Cohort (1)
Arm/Group Description	Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.
Overall Participants	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.0 (9.0)
Sex: Female, Male (Count of Participants)
Female	5 25%
Male	15 75%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Canada	20 100%
Smoking (%) (Count of Participants)
Count of Participants [Participants]	3 15%
Diabetes (%) (Count of Participants)
Count of Participants [Participants]	7 35%
Dyslipidemia (%) (Count of Participants)
Count of Participants [Participants]	14 70%
Hypertension (%) (Count of Participants)
Count of Participants [Participants]	15 75%

Outcome Measures

1. Primary Outcome

Title	Systolic Pressure
Description	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.

Outcome Measure Data

Analysis Population Description

Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.

Arm/Group Title	Prospective Cohort (1)
Arm/Group Description	Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.
Measure Participants	20
Mean (Standard Deviation) [mmHg]	133.4 (22.0)

2. Primary Outcome

Title	Diastolic Pressure
Description	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.

Outcome Measure Data

Analysis Population Description

Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.

Arm/Group Title	Prospective Cohort (1)
Arm/Group Description	Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.
Measure Participants	20
Mean (Standard Deviation) [mmHg]	67.4 (8.7)

3. Primary Outcome

Title	Systolic Pressure
Description	Peripheral arterial pressure (mm Hg)
Time Frame	Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.

Outcome Measure Data

Analysis Population Description

Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.

Arm/Group Title	Prospective Cohort (1)
Arm/Group Description	Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.
Measure Participants	20
Mean (Standard Deviation) [mmHg]	145.7 (20.2)

4. Primary Outcome

Title	Diastolic Pressure
Description	Peripheral arterial pressure (mm Hg)
Time Frame	Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.

Outcome Measure Data

Analysis Population Description

Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.

Arm/Group Title	Prospective Cohort (1)
Arm/Group Description	Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.
Measure Participants	20
Mean (Standard Deviation) [mmHg]	66.2 (9.1)

Adverse Events

Arm/Group Title	Prospective Cohort (1)
Arm/Group Description	Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.
All Cause Mortality
	Prospective Cohort (1)
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	Prospective Cohort (1)
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Prospective Cohort (1)
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

This study was an iterative process in the calibration and validation of the Cloud DX, Inc. Pulsewave Health Monitor oscillometric (automatic) wrist cuff device. The device has not yet been calibrated and validated via the ISO 81060-2_2020 'universal' protocol, although this requirement is currently in progress.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.