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NCT03446014 · ClinicalTrials.gov registry record
PAD Registry and Fitbit Sub-Study Program
A clinical trial, sponsored by University of Pennsylvania.
- Completed
- Registry status
- 41
- Enrollment target
NCT03446014: Completed study, sponsored by University of Pennsylvania.
NCT03446014 is a clinical trial that has completed, run by University of Pennsylvania. The registered enrollment target is 41 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03446014 has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- 41 participants
- Enrollment target
Study Summary
The genetic contribution and influence on the progression of peripheral artery disease (PAD) and possible cardiovascular events remains relatively unknown. As a result, the investigators are proposing for the creation of a registry of patients in the University of Pennsylvania Health System who are known to have PAD. The patients in this registry will be systematically monitored by conducting lower extremity ultrasound exams, ankle-brachial index (ABI) measurements, and six minute walk tests which have strong value in the positive diagnoses of PAD. These exams, combined with follow-up quality of life questionnaires, would allow for thorough monitoring of new diagnoses, symptoms, or serious adverse events. Blood will also be drawn looking for genetic biomarkers associated with this disease, which will provide further knowledge on the advancement and potential cardiovascular events associated with this disease. This blood will also be analyzed for components that will provide the investigators with knowledge of the patients overall blood vessel health. Micro RNA will also be evaluated to try to test if proteins and RNA in the blood can be used as predictors for future strokes or heart attacks. These exams will be repeated once annually over a duration of 10 years, with patients having hemodynamic monitoring as well as quality-of-life and cardiovascular events recorded at each visit. The data obtained from this registry will be compared to a created genetic profile looking for any genetic contribution to these new developments. Furthermore, this knowledge should offer impetus for physicians to target patients with these risk factors for the identification of potential adjustments to care.
Interventions
- DEVICE Fitbit Sub-Study
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2013-01 |
| Est. Completion | 2015-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03446014
The ClinicalTrials.gov registry entry for NCT03446014 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fitbit Sub-Study is the first listed.
NCT03446014 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03446014 about?
NCT03446014 is a clinical study titled "PAD Registry and Fitbit Sub-Study Program". The genetic contribution and influence on the progression of peripheral artery disease (PAD) and possible cardiovascular events remains relatively unknown. As a result, the investigators are proposing for the creation of a registry of patients in the University of Pennsylvania Health System who are ...
What is the current status of trial NCT03446014?
This trial is currently completed. The enrollment target is 41 participants. The study started on 2013-01. Estimated completion is 2015-01.
What interventions are being tested in trial NCT03446014?
The interventions under investigation include: Fitbit Sub-Study (DEVICE).
Who is sponsoring clinical trial NCT03446014?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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