NCT01622842

Brief Summary

The overall objectives were to investigate if characteristic dimensions for tissue and vessels determined from measured bioimpedance spectra would provide the same values as dimensions determined from MR images of the upper arm and verify that temporal variations of impedances could be converted to blood pressure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2011

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 19, 2012

Completed
Last Updated

June 22, 2012

Status Verified

June 1, 2012

Enrollment Period

Same day

First QC Date

June 8, 2012

Last Update Submit

June 21, 2012

Conditions

Hypertension

Keywords

ImpedanceElectricalTissueExcitation frequencyarterial distensiondistension wave form

Outcome Measures

Primary Outcomes (1)

  • Conductivities and permittivities in the spectral region from 1 KHz to 1 MHz.

    Measured on persons with: (a) a normal distribution of fat and muscles, (b) exceptionally thick layers of subcutaneous fat, and (c) exceptionally thin layers of subcutaneous fat. Both sexes should be represented. Muscles and vessels followed expectations based on litterature values for electrical properties. Subcutaneous fat had a higher conductivity and permittivity than predicted from literature values in all cases.

    1 hour

Secondary Outcomes (1)

  • Temporal variations synchronous with the heartbeat

    1 hour

Study Arms (1)

Bioimpedance

8 females and 8 males BMI from 19 to 46 SBP from 119 to 182

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Equal number of females and males. Large variations of BMI Large variations of BP

You may qualify if:

  • Age 18 - 80 years
  • Mental ability to understand information to test subjects

You may not qualify if:

  • Serious illness
  • Allergic reactions to ECG or EMG electrodes
  • Mentally unstable or unable to perceive instructions
  • Metal implants
  • Claustrophobia
  • Disqualified for MR scanning
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshopsitalet (Copenhagen Univ. Hospital)

Copenhagen, DK-4011, Denmark

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Lars Lading, Prof.

    Sense A/S

    STUDY DIRECTOR

  • Tine W Hansen, MD, PhD

    Rigshospitalet (Copenhagen Univ. Hospital)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2012

First Posted

June 19, 2012

Study Start

September 1, 2011

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

June 22, 2012

Record last verified: 2012-06

Locations

DK(1)