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

University of Limoges (UL)

Status: Completed

Conditions: Peripheral Arterial Disease, Ankle Brachial Index, Doppler

Treatments: Diagnostic Test: Measure ankle brachial index (ABI)

Study type: Interventional

Funder types: Other

Identifiers

NCT03511612

87RC17_0075 (ABIOSCILLO)

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

51 participants in 2 patient groups

Pattern A

Other group

Description:

Intervention : Each subject has 3 measurements of ABI starting with oscillometric device and then using the Doppler method.

Treatment:

Diagnostic Test: Measure ankle brachial index (ABI)

Pattern B

Other group

Description:

Intervention : Each subject has 3 measurements of ABI starting with Doppler method and then using oscillometric device.

Treatment:

Diagnostic Test: Measure ankle brachial index (ABI)