PAD Registry and Fitbit Sub-Study Program

500 subjects will be recruited from the general Philadelphia community and from the
University of Pennsylvania Healthcare System. This population will be carefully characterized
with assessment for cardiovascular risk factors to include smoking, diabetes mellitus,
hypertension, and previous surgery or vascular interventions. Those patients with the
presence of diabetes, hypertension, and hypercholesterolemia will be considered positive if
they are being prescribed drugs for each respective condition. Physician's clinics will be
screened for patients who meet the necessary inclusion criteria. These physicians will then
be contacted for permission to speak with the patient. Upon approval, a coordinator will
contact the patient regarding the study and to gauge interest. If interested, the coordinator
will go through a screening form with the patient, as well as schedule a baseline visit.
Subjects will also be recruited from Upenn research database comprised of subjects who have
participated in previous research studies and who have asked to be contacted for future
studies, such as CVI BioBank, Genetics of Cardiovascular and Metabolic Phenotypes (IRB
#808346). Potential subjects will also be recruited via Penn Data Store. Patients who cannot
be contacted directly will be contacted through the mail.

For their baseline visit, patients will be asked to read and sign the consent form, as well
as approached for participation in the CVI BioBank, Genetics of Cardiovascular and Metabolic
Phenotypes (IRB# 808346). Additionally, patients will be given the option of participating in
the activity monitoring sub-study. Patients will then asked to undergo an ABI measurement
using standardized methods - brachial and ankle systolic pressures will be measured with
appropriately sized cuffs attached to sphygmomanometers. Return of flow will be determined
using a continuous wave Doppler. In addition, patients will undergo a lower extremity duplex
ultrasound evaluation of their arterial system, with plaque being used as a measure of
disease progression. The evaluation will be done in coordination with the Inter-societal
Commission for Accreditation of Vascular Laboratory Guidelines. In each follow-up exam, PAD
progression will be defined as either a new stenosis or progression of a baseline stenosis to
an occlusion. Furthermore, patients will undergo a 6-MWD test, with the primary unit of
analysis being the total distance walked (in meters) regardless of whether the subjects
stopped or not during the conduct of the test. Patients will also have 10 mLs of blood drawn,
which will be evaluated for any genetic and vascular biomarkers that may have contributed to
the disease (see Section 3.0 for Analysis and Evaluation). Micro RNA will also be evaluated
for any predictors of future strokes or heart attacks. Study visits will be completed once
annually over duration of 10 years, with questionnaires being repeated every 6 months via
telephone. These questionnaires, the Walking Impairment Questionnaire (WIQ) and RAND-Item
short Form Survey, will be completed and will ask the patients about any interval changes in
medical history, any severe adverse events that may have occurred, and their overall quality
of life.

Patients enrolled in the optional activity monitoring sub study will be randomized to one of
two groups: intervention group or control group. Intervention group participants will receive
an activity monitor device (Fitbit http://www.fitbit.com/) and instructed on its use.
Additionally, coordinators will monitor the intervention groups usage of the device and make
routine recommendations on their activity level using the Way To Health platform. Way to
Health is an integrated research platform that uses online tools, wireless technologies, and
other applications to allow investigators to test ways of improving health behaviors and
helping people keep on track to better health. Patients in the intervention group will also
receive financial incentives for wearing the Fitbit and also be entered into a lottery if
they are reaching their goals. Patient's will be increased by the Way To Health program
according to the algorithm described below:

- <5000 steps: 50% increase on goal

- 5,001 - 7,500 steps: 40% increase on goal

- 7,501 - 10,000 steps: 30% increase on goal ->10,000 steps: 20% increase on goal

Participants in the control group will receive an activity monitoring device that they will
not be able to engage with but instructed to wear for monitoring purposes once a week every
month. Each subject will perform the same procedures used on patients not enrolled in the
sub-study. However, patients will be asked to return to our office for a 3 month follow-up
visit for a repeat 6 minute walk test and Walking Impairment Questionairre (WIQ). The data
recorded on the activity monitor device will be uploaded by the subjects for view via sync
through proprietary software on a smartphone, tablet, or computer. The data will be password
protected and will allow access to the investigator and the subjects randomized to the
intervention group to have access.

Inclusion Criteria:Patients between the ages of 18 and 90 and those patient's with PAD and
other risk factors (smoking, diabetes mellitus, hypertension, and previous surgery or
vascular interventions) will be included. These patients must have peripheral artery
disease with objective vascular laboratory measurements that confirm disease. Moreover,
patients will also be considered who have a history of PAD and a normal ABI after
revascularizations. Patients will also be screened for any prior adverse events such as
myocardial infarction or stroke.

Exclusion Criteria: Patients below that age of 18 and over the age of 90 who do not have a
positive diagnosis or history of PAD will be excluded from the study. Pregnant and
lactating women and those people unable to provide informed consent will also be excluded.
A patient will have the option to not participate in the study and not sign the informed
consent. If a patient declines to participate, there is no effect on the patient's regular,
ongoing cardiac care. Patients who do not access to a smartphone/tablet/computer or cannot
engage in active participation via the software program will be excluded from the Fitbit
sub-study.