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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 is a NA study that has completed, run by St. Louis University. The registered enrollment target is 238 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03161327
The ClinicalTrials.gov registry entry for NCT03161327 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 238 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Louis University, which has 107 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ABI using QuantaFlo™ is the first listed.
NCT03161327 reports 0 study locations.
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.
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