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

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ClinicalTrials.gov Identifier: NCT01022606
Recruitment Status : Terminated (Stopped for one complication event (arterial occlusion))
First Posted : December 1, 2009
Last Update Posted : March 18, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Brief Summary:
Confirm with invasive measurement the presence of a Walking-Induced Transient Hack (WITH) profile

Condition or disease Intervention/treatment Phase
Claudication Other: Arterial sampling Phase 1

Detailed Description:
Arterial PO2 and body temperature measurements during exercise

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Intra-arterial Measurement of pO2 in Walking Induced Transient Hack ("WITH") Profiles
Study Start Date : October 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Arm Intervention/treatment
Patients with walking limitation
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
Other: Arterial sampling
Arterial pO2 (ABL5) Body Temperature (Vitalsens Cortemp) tcpO2 TCM400
Other Name: All material is CE marked and approved for huamn use




Primary Outcome Measures :
  1. arterial pO2 [ Time Frame: 2 months (time required to organise the test) ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • walking induced transient Hack (WITH) tcpO2 profile

Exclusion Criteria:

  • rejection by patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022606


Locations
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France
University Hospital
Angers, France
Sponsors and Collaborators
University Hospital, Angers
Investigators
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Study Chair: P Abraham, MD, PhD University Hospital

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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01022606     History of Changes
Other Study ID Numbers: PE 2009-16
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: March 18, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
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Intermittent Claudication
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms