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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | September 8, 2005 | ||||||||||||
| Last Updated Date | March 16, 2007 | ||||||||||||
| Start Date ICMJE | March 2004 | ||||||||||||
| Primary Completion Date | |||||||||||||
| Current Primary Outcome Measures ICMJE | |||||||||||||
| Original Primary Outcome Measures ICMJE | |||||||||||||
| Change History | Complete list of historical versions of study NCT00152737 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Objective Evaluation of Proximal Ischemia | ||||||||||||
| Official Title ICMJE | Effet Des Gestes de Revascularisation à l'étage Proximal | ||||||||||||
| Brief Summary | The whole study is divided in 4 parallel protocols. The first protocol estimates the reliability of the technique through test-retest recordings. The second protocol aims to prove that exercise Tcpo2 is efficient to estimate the benefit of proximal revascularisation on proximal and distal ischemia in patients suffering stage two lower extremity arterial disease. The third protocol aims at estimating with exercise tcpo2 the eventual apparison of proximal ischemia after aorto-bi-femoral bypasses. The last protocol is a transversal study of patients with aorto-bi-femoral bypasses aiming to analyse the presence of proximal and distal symptoms and ischemia. The hypothesis for protocol 2 is that TcpO2 at exercise is significantly improved after surgery at the aortic and primary iliac artery. The hypothesis for protocols 3 and 4 relates on the hypothesis that a significant number of patients benefiting aorto-bi-femoral bypass suffer isolated proximal pain/ischemia after surgery. Amendement to the project has been recently validated to study the neurologic and bone complication of chronic vascular ischemia |
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| Detailed Description | Patients included are submitted to: San Diego Claudication Questionnaire before and during the treadmill test Treadmill test(s) through the Strandness procedure (2MPh 10% slope) Transcutaneous oxygen pressure recording before during and after exercise Ankle and brachial pressure measurements. Neurologic investigation with Quantitative sensory Testing (QST) and neurophysiological tests for patients included in the sub-group analysing neurologic complication Whole body densitometry for patients included in the sub-group analysing osteo-articular complications |
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| Study Phase | |||||||||||||
| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study | ||||||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Enrollment ICMJE | 165 | ||||||||||||
| Estimated Completion Date | July 2008 | ||||||||||||
| Primary Completion Date | |||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00152737 | ||||||||||||
| Responsible Party | |||||||||||||
| Study ID Numbers ICMJE | PHRC 03-01 | ||||||||||||
| Study Sponsor ICMJE | University Hospital, Angers | ||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University Hospital, Angers | ||||||||||||
| Verification Date | March 2007 | ||||||||||||
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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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