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Digital Ankle Brachial Index (ABI) as a Screening Tool in Detecting Peripheral Arterial Disease

NCT03161327 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2018-12-11

Study results available
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Summary

Peripheral artery disease (PAD) affects 8-18 million in the US and is an economic burden, currently estimated to be greater than cancer and heart disease. Older age (\> 65 years), smoking, diabetes and kidney diseases are some risk factors associated with PAD and are known to have increased morbidity and mortality.Early detection is critical for mitigating PAD progression. Ankle-brachial index (ABI) testing is recommended by the US Preventative Services Task Force as an affordable and effective screening tool for evaluating PAD risk.

QuantaFlo™ (Semler Scientific, Inc.) is a novel, noninvasive, 510K FDA approved digital device that is used as a screening tool to measure ABI of patients at risk of PAD. This single center prospective clinical trial will evaluate the sensitivity and specificity of digital ABI in detecting PAD using color Doppler ultrasound and 'gold standard' angiography as reference. Specifically in patient undergoing dialysis and who cannot undergo ABI using pressure cuffs dialysis grafts/ fistulae in the arms, we will evaluate the value of digital ABI in detecting PAD.

Conditions

Interventions

DEVICE

ABI using QuantaFlo™

Perform Digital ABI: * Will be performed by the nurse/medical assistant with training to perform this test * The patient will be placed in the supine position, with the arms and legs at the same level as the heart, for a minimum of 5 minutes before measurement. * The optical sensor (similar to a pulse oximeter) will be placed sequentially in the fingers of the hands and feet: Right and left hand fingers and then right and left feet toes. * Usually each digit takes about 15 seconds to obtain a waveform * At the end of 60 seconds, an automated digital ABI will be generated. Clinical course: If based on Screening questionnaire and digital ABI, I. Patient is diagnosed with PAD- the referring physician and patient will receive a phone call about the same. He/ she will then be advised any further testing/ referral to IR clinic. II. There is no evidence of PAD- no further action will be taken. The patient will be informed of the same.

Sponsors & Collaborators

  • St. Louis University

    lead OTHER

Principal Investigators

  • Keith Pereira, MD · Saint Louis University Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-15
Primary Completion
2017-09-14
Completion
2017-09-14
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03161327 on ClinicalTrials.gov