CLE-PAD : Prevalence of PAD in Patients With Surgically Lumbar Spinal Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRennes University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
contrast-enhanced CT scan
Diagnostic testcontrast-enhanced CT scan
Treatment groups
49 Participants
are divided into 1 treatment groupGroup A: ParticipantsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of patients with PAD identified during the contrast enhanced CT scan
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.
Time frame
3 monthsSecondary outcomes
1
Efficiency of diagnosis test "pulse"
determination of the sensitivity and specificity, positive predictive value and negative predictive value of the diagnostic test "pulse" : the absence of distal pulses will be considered pathological
Time frame
3 months2
Efficiency of diagnosis test "systolic pressure index"
determination of the sensitivity and specificity, positive predictive value and negative predictive value of the diagnostic test "systolic pressure index" : A resting systolic pressure index ≤ 0.90 will be considered pathological in accordance with the recommendations.
Time frame
3 months3
Efficiency of diagnosis test "toe systolic pressure index"
determination of the sensitivity and specificity, positive predictive value and negative predictive value of the diagnostic test "toe systolic pressure index" : A resting toe systolic pressure index ≤ 0.70 will be considered pathological in accordance with the recommendations.
Time frame
3 months4
Efficiency of diagnosis test "Aorto-iliac and lower limb Doppler ultrasound"
determination of the sensitivity and specificity, positive predictive value and negative predictive value of the diagnostic test "Aorto-iliac and lower limb Doppler ultrasound " : velocimetric criteria for stenosis and Saint-Bonnet B and CD, E and 0 Doppler curves considered pathological (i.e. AOMI) in accordance with recommendations .
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov