CLE-PAD : Prevalence of Lower Extremity Peripheral Artery Disease in Patients With Surgically Lumbar Spinal Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 49
- 试验地点
- 3
- 主要终点
- Number of patients with PAD identified during the contrast enhanced CT scan
研究概览
简要总结
The goal of this interventional study is to evaluate the rate of existing lower limb peripheral artery disease (PAD) in patients with surgically lumbar spinal stenosis (LSS). PAD and LSS can present similar symptoms and it can be difficult to diagnose PAD using conventional methods, depending on the location of the arterial disease. The main questions it aims to answer are :
- What's the prevalence of PAD in LSS patients?
- Which exam among routine tools is the most accurate to diagnose PAD in this population? Around their surgery for LSS (a few weeks before or after), participants will be included in a vascular medicine service. After checking of eligibility criteria, they will undergo a contrast-enhanced CT scan for the diagnosis of PAD and various routine diagnostic tests: Doppler ultrasound, treadmill tests, pressure index, pulse palpation.
详细描述
Lumbar spinal stenosis (LSS) is a debilitating degenerative condition in older people associated with lower back pain, pain in the lower limbs and a reduced quality of life. LSS can be treated surgically, but the results are mixed: 35% of patients report low satisfaction one year after surgery. The symptoms of LSC in the lower limbs can mimic those associated with peripheral arterial disease (PAD). The prevalence of PAD in the LSC population varies between 4.1% and 67.8% depending on the diagnostic tests used and the populations studied. Thus, the precise analysis of the prevalence of PAD and the sensitivity and specificity of PAD diagnostic tests in this population remain to be determined. These analyses would help to optimise PAD diagnostic tools, while possibly providing an explanation for the post-operative persistence of functional discomfort in CLE patients. Furthermore, a better understanding of the vascular system in the CLE population offers hope for optimising patient care, both from a medical and a medico-economic point of view.
The experimental visit takes place as soon as possible after receipt of the biological assessment and within a maximum period of 3 months. During this visit, specific research examinations will be performed, including stress tests (stress TcPO2 according to the modified Strandness protocol and stress TcPO2 according to the Gardner-Skinner increasing load protocol), as well as an injected scan of the aorta of the lower limbs. The pseudonymised CT scan will be sent to the sponsor for blind review. A follow-up telephone call will be made between 7 and 10 days after the CT scan to detect the occurrence of any adverse events. The study will then be completed for the participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Presenting with a lumbar spinal stenosis with surgical indication, either unoperated or operated on less than 3 months ago
- •Affiliated with a social security scheme
- •Having received oral and written information about the protocol and having signed a written consent form to participate in this research.
排除标准
- •emergency surgical care
- •Contraindication to contrast enhanced CT scan
- •Stroke or myocardial infarction (MI) within the last 3 months
- •Known severe or poorly tolerated arrhythmia
- •Known severe or symptomatic left ventricular outflow obstruction
- •Decompensated heart failure
- •History within the last 3 months of venous thromboembolic disease, myopericarditis, endocarditis, aortic dissection or intracardiac thrombus
- •Severe uncontrolled hypertension (BP > 200/110 mmHg)
- •Inability to walk on the treadmill
- •Major lower limb amputation
- •Adult subject to legal protection
研究组 & 干预措施
Participants
干预措施: contrast-enhanced CT scan (Diagnostic Test)
结局指标
主要结局
Number of patients with PAD identified during the contrast enhanced CT scan
时间窗: 3 months
Number of patients with PAD identified during the contrast enhanced CT scan. PAD will be defined by the presence of at least one arterial stenosis ≥ 50% on the arterial axes located from the abdominal aorta to the origin of the tibiofibular arterial trunk, as determined by CT scan of the aorta and lower limbs in accordance with the recommendations.
次要结局
- Efficiency of diagnosis test "pulse"(3 months)
- Efficiency of diagnosis test "systolic pressure index"(3 months)
- Efficiency of diagnosis test "toe systolic pressure index"(3 months)
- Efficiency of diagnosis test "Aorto-iliac and lower limb Doppler ultrasound"(3 months)
- Efficiency of diagnosis test "exercise oxymetry"(3 months)
