Objective Evaluation of Proximal Ischemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by University Hospital, Angers.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Sanofi-Synthelabo
Société Française de Médecine Vasculaire
Information provided by:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT00152737
First received: September 8, 2005
Last updated: March 16, 2007
Last verified: March 2007

September 8, 2005
March 16, 2007
March 2004
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Complete list of historical versions of study NCT00152737 on ClinicalTrials.gov Archive Site
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Objective Evaluation of Proximal Ischemia
Effet Des Gestes de Revascularisation à l'étage Proximal

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

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

Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
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  • Intermittent Claudication
  • Peripheral Vascular Diseases
  • Procedure: Exercise test with Transcutaneous oxygene pressure
  • Procedure: Ankle and arm pressure values
  • Procedure: San diego claudication questionnaire
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
165
July 2008
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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)
Both
18 Years and older
No
Contact: Pierre ABRAHAM, MD, PhD +33 (0) 2.41.35.36.89 piabraham@chu-angers.fr
France
 
NCT00152737
PHRC 03-01
Yes
Not Provided
University Hospital, Angers
  • Sanofi-Synthelabo
  • Société Française de Médecine Vasculaire
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
University Hospital, Angers
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP