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

Primary Purpose

Peripheral Arterial Disease, Ankle Brachial Index, Doppler

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Measure ankle brachial index (ABI)
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Peripheral Arterial Disease, Ankle Brachial Index, Doppler

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Pattern A

Pattern B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Measurement of the ABI
Measurement of the ABI, with Doppler method as reference

Secondary Outcome Measures

Full Information

First Posted
April 18, 2018
Last Updated
January 21, 2019
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT03511612
Brief Title
Comparison of the Ankle-Brachial Index Measurement Using a Specific Oscillometric Device vs. the Doppler Method
Acronym
ABIOSCILLO
Official Title
Comparison of the Ankle-Brachial Index Measurement Using a Specific Oscillometric Device vs. the Doppler Method
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 24, 2018 (Actual)
Primary Completion Date
October 24, 2018 (Actual)
Study Completion Date
October 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Ankle Brachial Index, Doppler

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pattern A
Arm Type
Other
Arm Description
Intervention : Each subject has 3 measurements of ABI starting with oscillometric device and then using the Doppler method.
Arm Title
Pattern B
Arm Type
Other
Arm Description
Intervention : Each subject has 3 measurements of ABI starting with Doppler method and then using oscillometric device.
Intervention Type
Diagnostic Test
Intervention Name(s)
Measure ankle brachial index (ABI)
Intervention Description
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 Outcome Measure Information:
Title
Measurement of the ABI
Description
Measurement of the ABI, with Doppler method as reference
Time Frame
Day of the inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital
City
Limoges
ZIP/Postal Code
87200
Country
France

12. IPD Sharing Statement

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

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