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Intra-arterial Measurement of pO2 in Walking Induced Transient Hack Profiles (Initial-VHS)

Primary Purpose

Claudication

Status
Terminated
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Arterial sampling
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Claudication

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • walking induced transient Hack (WITH) tcpO2 profile

Exclusion Criteria:

  • rejection by patient

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with walking limitation

Arm Description

Patients with claudication and Walking-Induced Transient Hack (W.I.T.H.) tcpO2 profiles are tested on treadmill with invasive pO2 arterial sampling and body temperature recording

Outcomes

Primary Outcome Measures

arterial pO2

Secondary Outcome Measures

Full Information

First Posted
November 24, 2009
Last Updated
March 15, 2013
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT01022606
Brief Title
Intra-arterial Measurement of pO2 in Walking Induced Transient Hack Profiles
Acronym
Initial-VHS
Official Title
Intra-arterial Measurement of pO2 in Walking Induced Transient Hack ("WITH") Profiles
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Why Stopped
Stopped for one complication event (arterial occlusion)
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Confirm with invasive measurement the presence of a Walking-Induced Transient Hack (WITH) profile
Detailed Description
Arterial PO2 and body temperature measurements during exercise

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Claudication

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with walking limitation
Arm Type
Other
Arm Description
Patients with claudication and Walking-Induced Transient Hack (W.I.T.H.) tcpO2 profiles are tested on treadmill with invasive pO2 arterial sampling and body temperature recording
Intervention Type
Other
Intervention Name(s)
Arterial sampling
Other Intervention Name(s)
All material is CE marked and approved for huamn use
Intervention Description
Arterial pO2 (ABL5) Body Temperature (Vitalsens Cortemp) tcpO2 TCM400
Primary Outcome Measure Information:
Title
arterial pO2
Time Frame
2 months (time required to organise the test)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: walking induced transient Hack (WITH) tcpO2 profile Exclusion Criteria: rejection by patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
P Abraham, MD, PhD
Organizational Affiliation
University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital
City
Angers
Country
France

12. IPD Sharing Statement

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Intra-arterial Measurement of pO2 in Walking Induced Transient Hack Profiles

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