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NCT03161327 · ClinicalTrials.gov registry record · NA
Digital Ankle Brachial Index (ABI) as a Screening Tool in Detecting Peripheral Arterial Disease
A NA study, sponsored by St. Louis University.
- Completed
- Registry status
- NA
- Development phase
- 238
- Enrollment target
NCT03161327: Completed NA study, sponsored by St. Louis University.
NCT03161327 is a NA study that has completed, run by St. Louis University. The registered enrollment target is 238 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03161327, a NA study, has completed, sponsored by St. Louis University.
- COMPLETED
- Registry status
- NA
- Development phase
- 238 participants
- Enrollment target
Study 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.
Primary Outcome
To evaluate the Positive predictive value of digital ABI in diagnosing PAD using color Doppler ultrasound and 'gold standard' angiography as reference.
Interventions
- DEVICE ABI using QuantaFlo™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 238 participants |
| Start Date | 2017-07-15 |
| Est. Completion | 2017-09-14 |
| Phase | NA |
What the finished NCT03161327 record still lists
NCT03161327 is an interventional study that assigns participants to a tested intervention. The registered 238 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which ABI using QuantaFlo™ is the first listed.
NCT03161327 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03161327 about?
NCT03161327 is a clinical study titled "Digital Ankle Brachial Index (ABI) as a Screening Tool in Detecting Peripheral Arterial Disease". 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 morbidit...
What is the current status of trial NCT03161327?
This trial is currently completed. It is a NA study. The enrollment target is 238 participants. The study started on 2017-07-15. Estimated completion is 2017-09-14.
What interventions are being tested in trial NCT03161327?
The interventions under investigation include: ABI using QuantaFlo™ (DEVICE).
Who is sponsoring clinical trial NCT03161327?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03161327's enrollment target sits among peer trials
238 459th of 2000 higher than 1,540 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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