NCT01801579

Brief Summary

Hemodynamic changes in the lower limbs are very important and rapid after maximal exercise. The automatic method allows a fastest measurement of the Ankle-Brachial Index (ABI). Thus, it appears important to know whether automatic assessment of ABI is as reliable and reproducible as the manual method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2012

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, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

February 12, 2016

Status Verified

February 1, 2016

Enrollment Period

1.4 years

First QC Date

February 18, 2013

Last Update Submit

February 11, 2016

Conditions

Normal Subjects

Keywords

Ankle Brachial IndexMaximal exercise

Outcome Measures

Primary Outcomes (1)

  • Test-retest difference in ankle to brachial pressure index

    Comparison of differendces observed on test-retest measures with manual and automatic measurements

    up to 2 week

Secondary Outcomes (1)

  • Duration of recordings.

    up to 2 weeks

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

health volunteers over 18 years old

You may qualify if:

  • Participant between 18 and 40 years old
  • Informed consent signed

You may not qualify if:

  • Do not want to participate to the protocol
  • Pregnant woman
  • Adults to enhanced protection, deprived of their liberty by judicial or administrative authority, without consent hospitalized or admitted to a health facility or social purposes other than research
  • Amputee or with a member dysgenesis
  • Not allowed to perform a maximal exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Angers, 49933, France

Location

Study Officials

  • Antoine BRUNEAU, MD

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 18, 2013

First Posted

March 1, 2013

Study Start

November 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

February 12, 2016

Record last verified: 2016-02

Locations

FR(1)