Digital Ankle Brachial Index (ABI) as a Screening Tool in Detecting Peripheral Arterial Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03161327|
Recruitment Status : Completed
First Posted : May 19, 2017
Results First Posted : December 11, 2018
Last Update Posted : December 11, 2018
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||238 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
ABI will be performed in patient
Device: ABI using QuantaFlo™
Perform Digital ABI:
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.
- 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.
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
|United States, Missouri|
|Saint Louis University|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Keith Pereira, MD||Saint Louis University Hospital|