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

Peripheral Arterial Disease, Ankle Brachial Index, Doppler Clinical Trial

— ABIOSCILLO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03511612
• Other study ID #: 87RC17_0075 (ABIOSCILLO)
• Status: Completed
• Phase: N/A
• Start date: April 24, 2018
• Est. completion date: October 24, 2018

Study information

• Verified date: April 2018
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 24, 2018
• Est. primary completion date: October 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Arterial Disease, Ankle Brachial Index, Doppler
• Peripheral Vascular Diseases

Intervention

Diagnostic Test:
• Measure 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

Locations

Country	Name	City	State
France	University Hospital	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of the ABI	Measurement of the ABI, with Doppler method as reference	Day of the inclusion