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

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.

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Key information

Conditions

Peripheral Arterial Disease, Ankle Brachial Index, Doppler Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Limoges, 87200, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measure ankle brachial index (ABI)

Diagnostic Test

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

Primary outcomes

Measurement of the ABI

Time frame: Day of the inclusion

Measurement of the ABI, with Doppler method as reference

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: ABIOSCILLO

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Apr 30, 2018
Registry last updated: Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed