PAD Registry and Fitbit Sub-Study Program

Completed

Conditions studied: Peripheral Artery Disease

In brief

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.

Key facts

Study ID
NCT03446014
Run by
University of Pennsylvania
People needed
41
Starts
2013-01-01
Expected to finish
2015-01-01
Last updated by the study team
2019-04-04

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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