NCT03015363

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

August 30, 2021

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

2.5 years

First QC Date

January 5, 2017

Results QC Date

August 3, 2021

Last Update Submit

August 3, 2021

Conditions

Hypertension

Keywords

HypertensionTelemonitoringVital signs

Outcome Measures

Primary Outcomes (4)

  • Systolic Pressure

    Central aortic pressure (mmHg)

    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)

    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)

    Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.

  • Diastolic Pressure

    Peripheral arterial pressure (mm Hg)

    Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Horizon Health Network

Saint John, New Brunswick, Canada

Location

Related Publications (1)

  • 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.

    PMID: 29695375DERIVED

Related Links

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Limitations and 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.

Results Point of Contact

Title
Sohrab Lutchmedial, MD, FRCP(C)
Organization
CardioVascular Research New Brunswick (CVR-NB)
sohrab.lutchmedial@horizonnb.ca
506-648-6101

Study Officials

  • Sohrab Lutchmedial, MD, FRCPC

    Cardiovascular Research New Brunswick

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Director of CVR-NB/ Director of NBHC Catheterization Laboratory

Study Record Dates

First Submitted

January 5, 2017

First Posted

January 10, 2017

Study Start

November 1, 2013

Primary Completion

May 1, 2016

Study Completion

December 1, 2018

Last Updated

August 30, 2021

Results First Posted

August 30, 2021

Record last verified: 2021-08

Locations

CA(1)