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

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease, Ankle Brachial Index, Doppler
• Interventions: Diagnostic Test: Measure ankle brachial index (ABI)

• Registration Number: NCT03511612
• Lead Sponsor: University Hospital, Limoges

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-04
• Study First Submitted: 2018-04-18
• Study First Submitted QC: 2018-04-18
• Study Start: 2018-04-24
• Study First Posted: 2018-04-30
• Primary Completion: 2018-10-24
• Study Completion: 2018-10-24
• Last Update Submitted: 2019-01-21
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pattern B	Measure ankle brachial index (ABI)	Intervention : Each subject has 3 measurements of ABI starting with Doppler method and then using oscillometric device.
Pattern A	Measure ankle brachial index (ABI)	Intervention : Each subject has 3 measurements of ABI starting with oscillometric device and then using the Doppler method.

Primary Outcome Measures

Name	Time	Method
Measurement of the ABI	Day of the inclusion	Measurement of the ABI, with Doppler method as reference

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Limoges, France