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
About this trial
This is an interventional diagnostic trial for Claudication
Eligibility Criteria
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
NCT ID
NCT01022606
First Posted
November 24, 2009
Last Updated
March 15, 2013
Sponsor
University Hospital, Angers
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
Learn more about this trial
Intra-arterial Measurement of pO2 in Walking Induced Transient Hack Profiles
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