Intra-arterial Measurement of pO2 in Walking Induced Transient Hack Profiles (Initial-VHS)
This study has been terminated.
(Stopped for one complication event (arterial occlusion))
Sponsor:
University Hospital, Angers
Information provided by (Responsible Party):
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01022606
First received: November 24, 2009
Last updated: March 15, 2013
Last verified: March 2013
| Tracking Information | |||||
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| First Received Date ICMJE | November 24, 2009 | ||||
| Last Updated Date | March 15, 2013 | ||||
| Start Date ICMJE | October 2009 | ||||
| Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
arterial pO2 [ Time Frame: 2 months (time required to organise the test) ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01022606 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intra-arterial Measurement of pO2 in Walking Induced Transient Hack Profiles | ||||
| Official Title ICMJE | Intra-arterial Measurement of pO2 in Walking Induced Transient Hack ("WITH") Profiles | ||||
| Brief Summary | Confirm with invasive measurement the presence of a Walking-Induced Transient Hack (WITH) profile |
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| Detailed Description | Arterial PO2 and body temperature measurements during exercise |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Diagnostic |
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| Condition ICMJE | Claudication | ||||
| Intervention ICMJE | Other: Arterial sampling
Arterial pO2 (ABL5) Body Temperature (Vitalsens Cortemp) tcpO2 TCM400
Other Name: All material is CE marked and approved for huamn use |
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| Study Arm (s) | 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
Intervention: Other: Arterial sampling |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 10 | ||||
| Completion Date | October 2012 | ||||
| Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01022606 | ||||
| Other Study ID Numbers ICMJE | PE 2009-16 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | University Hospital, Angers | ||||
| Study Sponsor ICMJE | University Hospital, Angers | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Angers | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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