CLE-PAD : Prevalence of PAD in Patients With Surgically Lumbar Spinal Stenosis

Official title

CLE-PAD : Prevalence of Lower Extremity Peripheral Artery Disease in Patients With Surgically Lumbar Spinal Stenosis

Overview

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.

Detailed description

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.

Interventions

• Diagnostic test contrast-enhanced CT scan
  contrast-enhanced CT scan

Primary outcome measures

• Number of patients with PAD identified during the contrast enhanced CT scan [Time frame: 3 months]

Secondary outcome measures (5)

• Efficiency of diagnosis test "pulse" [Time frame: 3 months]
• Efficiency of diagnosis test "systolic pressure index" [Time frame: 3 months]
• Efficiency of diagnosis test "toe systolic pressure index" [Time frame: 3 months]
• Efficiency of diagnosis test "Aorto-iliac and lower limb Doppler ultrasound" [Time frame: 3 months]
• Efficiency of diagnosis test "exercise oxymetry" [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

France · 3 centers

• Groupement des Hôpitaux de l'Institut Catholique de Lille — Lille
• Groupe hospitalier Paris Saint Joseph — Paris
• CHU Rennes — Rennes

Identifiers

NCT: NCT07469020 · 35R24_8825_04_CLE-PAD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗