NCT02444650

Brief Summary

Optically-based data will be compared to tonometry to determine correlation of pulse wave velocity measurement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2015

Shorter than P25 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

April 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 10, 2015

Status Verified

July 1, 2015

Enrollment Period

3 months

First QC Date

April 29, 2015

Last Update Submit

July 9, 2015

Conditions

Healthy

Keywords

Correlationpulse wave velocity measurementtonometry

Outcome Measures

Primary Outcomes (1)

  • Optically based pulse wave velocity measurement correlation to the tonometry measure.

    2 hours

Interventions

Pulse wave velocity measurement PhotoplethysmogramDEVICE

Correlation of pulse wave velocity measurement.

tonometerDEVICE

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy normotensive and hypertensive subjects.

You may qualify if:

  • Between the ages of18-25 and 65-90 will be studied.
  • Normotensive and hypertensive subjects
  • Willing to provide informed consent

You may not qualify if:

  • has finger deformities or amputations that will prohibit proper sensor placement
  • pregnant or actively trying to get pregnant
  • Cardiogreen or other intravascular/tissue dyes less than 5 hours prior to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Study Officials

  • Timothy Curry, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2015

First Posted

May 14, 2015

Study Start

April 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 10, 2015

Record last verified: 2015-07

Locations

US(1)