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

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ClinicalTrials.gov Identifier: NCT03161327
Recruitment Status : Completed
First Posted : May 19, 2017
Results First Posted : December 11, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Keith Pereira, MD:, St. Louis University

Brief 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.


Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Amputation Smoking Diabetes Hypercholesterolemia Hypertension Device: ABI using QuantaFlo™ Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 238 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Positive Predictive Value of Digital Ankle Brachial Index (ABI) as a Screening Tool in Detecting Peripheral Arterial Disease: A Single Center, Prospective Clinical Trial
Actual Study Start Date : July 15, 2017
Actual Primary Completion Date : September 14, 2017
Actual Study Completion Date : September 14, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
ABI
ABI will be performed in patient
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.





Primary Outcome Measures :
  1. Positive Predictive Value of Digital ABI in Diagnosing PAD [ Time Frame: 3 months ]
    To evaluate the Positive predictive value of digital ABI in diagnosing PAD using color Doppler ultrasound and 'gold standard' angiography as reference.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Answering yes to any of the following questions on the clinical screening questionnaire:

  • Are you 65 years or older?
  • Have you ever smoked?
  • Do you have diabetes?
  • Do you have high blood pressure or take medication for high blood pressure?
  • Do you have high cholesterol, or take medication for high cholesterol?
  • Have you previously had a stroke?
  • Do you have heart disease?
  • Do you experience any pain at rest in your lower legs or feet?
  • Do you have discomfort (aching, fatigue, tingling, cramping or pain) when you walk, which is relieved by rest? Does the pain go away within 10 minutes after stopping?
  • Are your toes or feet pale, discolored, or bluish?
  • Do you have an infection, skin wound, or ulcer on your feet or toes?

Exclusion Criteria:

  • Not meeting the above criteria.
  • Previously screened with ABI in past 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03161327


Locations
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United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
St. Louis University
Investigators
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Principal Investigator: Keith Pereira, MD Saint Louis University Hospital
  Study Documents (Full-Text)

Documents provided by Keith Pereira, MD:, St. Louis University:

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Responsible Party: Keith Pereira, MD:, Assistant Professor, St. Louis University
ClinicalTrials.gov Identifier: NCT03161327     History of Changes
Other Study ID Numbers: 28225
First Posted: May 19, 2017    Key Record Dates
Results First Posted: December 11, 2018
Last Update Posted: December 11, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Keith Pereira, MD:, St. Louis University:
ankle brachial index
peripheral arterial disease
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Hypercholesterolemia
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases