Validation of Ankle-Barchial Index Measurement Using a Multi-Cuff Oscillometric Device Versus the Standard Doppler Method.

Validation of Ankle-Barchial Index Measurement Using a Multi-Cuff Oscillometric Device Versus the Standard Doppler Method. - Validation of Ankle-Barchial Index Measurement Using a Multi-Cuff Oscillometric Device

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000037436

Enrollment

120

Registered

2019-08-01

Start date

2016-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral arterial disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients suspect for lower extremity artery disease (LEAD) because of intermittent claudication or more atypical pain when walking, critical limb ischemia or leg/foot ulcers Asymptomatic individuals with the presence of at least two cardiovascular risk factors among the following Men > 60 years or women > 65 years Regular cigarette smoking (either current or in the past) for more than 10 years, Treated type-2 diabetes mellitus >5 years or type-1 diabetes mellitus >20 years, Treated hypertension or systolic blood pressure>140mmHg 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 percutaneous coronary intervention or coronary artery bypass grafting or previous myocardial infarction, or coronary artery disease documented by coronary angiography) Documented history of ischemic stroke Patients with re-vascularized LEAD

Exclusion criteria

Exclusion criteria: Cardiac arrhythmia: Atrial fibrillation, atrial flutter, frequent supra and ventricular ectopic beats Patients under dialysis

Design outcomes

Primary

Measure	Time frame
Sensitivity, specificity, PPV, NPV, and Prevalence of the oscillometric method to detect a low (<0.90) ABI were determined by usual formula, taking the Doppler method as the reference.	—

Secondary

Measure	Time frame
The intra and interobserver variability of measurements were first assessed by the determination of the intraclass correlation coefficient (ICC) of agreement for each method. In order to determine methods with the best reproducibility (the lowest variability), 95% CI of these ICCs were then compared. A second analysis of intra- and inter-observer reproducibility were made by the Bland and Altman's method.	—

Measure

Time frame

The intra and interobserver variability of measurements were first assessed by the determination of the intraclass correlation coefficient (ICC) of agreement for each method. In order to determine methods with the best reproducibility (the lowest variability), 95% CI of these ICCs were then compared. A second analysis of intra- and inter-observer reproducibility were made by the Bland and Altman's method.

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Countries

Japan,Europe

Contacts

Public ContactShigeo Ichihashi

Nara Medical University Radiology

ichihash@naramed-u.ac.jp0744-29-8900

Outcome results