Peripheral Arterial Disease, Ankle Brachial Index, Doppler
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTMeasure ankle brachial index (ABI)
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
Sponsors
University Hospital, Limoges
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of the ABI | Day of the inclusion | Measurement of the ABI, with Doppler method as reference |
Countries
France
Outcome results
None listed