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Objective Evaluation of Proximal Ischemia

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ClinicalTrials.gov Identifier: NCT00152737
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : July 17, 2015
Sponsor:
Collaborators:
Sanofi-Synthelabo
Société Française de Médecine Vasculaire
Information provided by (Responsible Party):
University Hospital, Angers

Study Description
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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


Condition or disease Intervention/treatment
Intermittent Claudication Peripheral Vascular Diseases Procedure: Exercise test with Transcutaneous oxygene pressure Procedure: Ankle and arm pressure values

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

Study Design
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Study Type : Observational
Actual Enrollment : 165 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effet Des Gestes de Revascularisation à l'étage Proximal
Study Start Date : March 2004
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008
Groups and Cohorts
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Intervention Details:
  • Procedure: Exercise test with Transcutaneous oxygene pressure
    Ce marked devices
  • Procedure: Ankle and arm pressure values
    one test before and one test after surgery

Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with claudication
Criteria

Inclusion Criteria:

  • protocol 1 - 3 stage 2 claudication
  • Protocols 2 & 3 : Indication for surgery
  • protocol 4 : Patent aorto bio femoral bypass for more than 4 months
  • Ability to perform a treadmill test

Exclusion Criteria:

  • Stage 4 LEAD
  • Aortic aneurysm
  • Acute coronary syndrom
  • claudication of documented non vascular origin (for protocols 1-3 only)
Contacts and Locations
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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): NCT00152737


Locations
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France
Laboratoire d'explorations vasculaires
Angers, France, 49033
Sponsors and Collaborators
University Hospital, Angers
Sanofi-Synthelabo
Société Française de Médecine Vasculaire
Investigators
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Study Chair: jean louis Saumet, MD PhD University Hospital in Angers
Principal Investigator: Pierre Abraham, MD PhD University Hospital in Angers
Study Chair: Bernard Enon, MD University Hospital in Angers
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT00152737    
Other Study ID Numbers: PHRC 03-01
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: July 17, 2015
Last Verified: July 2015
Keywords provided by University Hospital, Angers:
Intermittent Claudication
Peripheral Vascular Diseases
Blood Gas Monitoring, Transcutaneous
Surgery
Additional relevant MeSH terms:
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Vascular Diseases
Intermittent Claudication
Peripheral Vascular Diseases
Peripheral Arterial Disease
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Atherosclerosis