Comparison of the Ankle-Brachial Index Measurement Using a Specific Oscillometric Device vs. the Doppler Method

Study Overview
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Brief Summary
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Several methods are available to measure ankle brachial index (ABI) non-invasively. A recent scientific statement of the AHA considers the Doppler method as the reference. However because Doppler devices are not widely available in primary care, several attempts have been made to propose alternative methods, among whom oscillometric methods (automatic blood pressure machines) have attracted most attention. We hypothesize that: - the diagnostic characteristics (i.e. sensitivity, specificity and AUC) of the oscillometric method would be very good as compared to the Doppler method. the oscillometric method would have better intra- and inter-observer reproducibilities as compared to the Doppler method.

Official Title
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Comparison of the Ankle-Brachial Index Measurement Using a Specific Oscillometric Device vs. the Doppler Method

Conditions
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Peripheral Arterial Disease, Ankle Brachial Index, Doppler

Intervention / Treatment
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* Diagnostic Test: Measure ankle brachial index (ABI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients referred with the suspicion of PAD, either because of: symptoms in favor of intermittent claudication or more atypical pain when walking, or asymptomatic individuals with the presence of at least 2 cardiovascular risk factors among the following : Men > 60 years or women > 65 years Regular cigarette smoking >10 years, either current or in the past Treated Type-2 diabetes >5 years or Type-1 diabetes >20 years Treated hypertension High blood cholesterol (either total-C >240 mg/dl or LDL-C >160 mg/dl) or treated by statins or other lipid-lowering agents Documented history of coronary artery disease (history of PCI or CABG, or previous myocardial infarction, or CAD documented by coronary angiography) Documented history of ischemic stroke Exclusion Criteria: Patients with revascularized PAD Patients with critical limb ischemia or leg/foot ulcers Cardiac arrhythmia: Atrial fibrillation, atrial flutter, frequent supra- and ventricular ectopic beats Patients under dialysis

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pattern A<br>Intervention : Each subject has 3 measurements of ABI starting with oscillometric device and then using the Doppler method. | Diagnostic Test: Measure ankle brachial index (ABI)<br>* This is a head-to-head comparison of 2 methods of determination of the ABI, taking the Doppler method as the standard and the oscillometric device AVP as the challenger<br>|
| Other: Pattern B<br>Intervention : Each subject has 3 measurements of ABI starting with Doppler method and then using oscillometric device. | Diagnostic Test: Measure ankle brachial index (ABI)<br>* This is a head-to-head comparison of 2 methods of determination of the ABI, taking the Doppler method as the standard and the oscillometric device AVP as the challenger<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the ABI | Measurement of the ABI, with Doppler method as reference | Day of the inclusion |