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临床试验/NCT00152737
NCT00152737已完成不适用

Effet Des Gestes de Revascularisation à l'étage Proximal

University Hospital, Angers1 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2004年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
165
试验地点
1

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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