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
  Purpose

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 Intervention
Intermittent Claudication
Peripheral Vascular Diseases
Procedure: Exercise test with Transcutaneous oxygene pressure
Procedure: Ankle and arm pressure values
Procedure: San diego claudication questionnaire

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Effet Des Gestes de Revascularisation à l'étage Proximal

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

Estimated Enrollment: 165
Study Start Date: March 2004
Estimated Study Completion Date: July 2008
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152737

Contacts
Contact: Pierre ABRAHAM, MD, PhD +33 (0) 2.41.35.36.89 piabraham@chu-angers.fr

Locations
France
Laboratoire d'explorations vasculaires Recruiting
Angers, France, 49033
Contact: Pierre Abraham, MD PhD    +33 (0) 2.41.35.36.89      
Sponsors and Collaborators
University Hospital, Angers
Sanofi-Synthelabo
Société Française de Médecine Vasculaire
Investigators
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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00152737     History of Changes
Other Study ID Numbers: PHRC 03-01
Study First Received: September 8, 2005
Last Updated: March 16, 2007
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Angers:
Intermittent Claudication
Peripheral Vascular Diseases
Blood Gas Monitoring, Transcutaneous
Surgery

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Intermittent Claudication
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 02, 2014