Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03015363
Recruitment Status : Unknown
Verified February 2018 by Sohrab Lutchmedial, MD, FRCPC, Cardiovascular Research New Brunswick.
Recruitment status was:  Active, not recruiting
First Posted : January 10, 2017
Last Update Posted : February 20, 2018
Sponsor:
Collaborators:
Horizon Health Network
Cloud Diagnostics, Incorporated
New Brunswick Health Research Foundation
Information provided by (Responsible Party):
Sohrab Lutchmedial, MD, FRCPC, Cardiovascular Research New Brunswick

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
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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
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 : November 2013
Actual Primary Completion Date : May 2016
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Systolic pressure [ Time Frame: Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure. ]
  2. Diastolic pressure [ Time Frame: Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure. ]

Secondary Outcome Measures :
  1. Pulse rate [ Time Frame: Non-invasive blood pressure device measurements on day of cardiac catheterization procedure. ]
  2. Breathing rate [ Time Frame: Non-invasive blood pressure device measurements on day of cardiac catheterization procedure. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015363


Locations
Layout table for location information
Canada, New Brunswick
Horizon Health Network
Saint John, New Brunswick, Canada
Sponsors and Collaborators
Cardiovascular Research New Brunswick
Horizon Health Network
Cloud Diagnostics, Incorporated
New Brunswick Health Research Foundation
Investigators
Layout table for investigator information
Principal Investigator: Sohrab Lutchmedial, MD, FRCPC Cardiovascular Research New Brunswick
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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: January 10, 2017    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Sohrab Lutchmedial, MD, FRCPC, Cardiovascular Research New Brunswick:
Hypertension
Telemonitoring
Vital signs
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases