Clinical trial NCT00152737: Objective Evaluation of Proximal Ischemia
Official title: Effet Des Gestes de Revascularisation à l'étage Proximal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intermittent Claudication
Peripheral Vascular Diseases
Keywords: Intermittent Claudication
Peripheral Vascular Diseases
Blood Gas Monitoring, Transcutaneous
Surgery
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Sanofi-Synthelabo
name: Société Française de Médecine Vasculaire
First posted: 2005-09-09
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with claudication

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

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

Eligibility 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Laboratoire d'explorations vasculaires
Study officials:
affiliation: University Hospital in Angers
name: jean louis Saumet, MD PhD
role: STUDY_CHAIR
affiliation: University Hospital in Angers
name: Pierre Abraham, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital in Angers
name: Bernard Enon, MD
role: STUDY_CHAIR
References:
citation: Jaquinandi V, Picquet J, Bouye P, Saumet JL, Leftheriotis G, Abraham P. High prevalence of proximal claudication among patients with patent aortobifemoral bypasses. J Vasc Surg. 2007 Feb;45(2):312-8. doi: 10.1016/j.jvs.2006.09.050.
citation: Jaquinandi V, Abraham P, Picquet J, Paisant-Thouveny F, Leftheriotis G, Saumet JL. Estimation of the functional role of arterial pathways to the buttock circulation during treadmill walking in patients with claudication. J Appl Physiol (1985). 2007 Mar;102(3):1105-12. doi: 10.1152/japplphysiol.00912.2006. Epub 2006 Nov 16.
citation: Ouedraogo N, Feuilloy M, Mahe G, Leftheriotis G, Saumet JL, Abraham P. Chest tcpO2 changes during constant-load treadmill walking tests in patients with claudication. Physiol Meas. 2011 Feb;32(2):181-94. doi: 10.1088/0967-3334/32/2/003. Epub 2010 Dec 22.