PAD Registry and Fitbit Sub-Study Program (PADR)

April 2, 2019 updated by: University of Pennsylvania

The Genetic and Risk Factor Contribution to the Progression of Peripheral Artery Disease and Severe Adverse Events

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Peripheral Artery Disease is a disease that is highly prevalent within the United States, affecting close to 8-12 million individuals. These individuals' qualities of life are likely impaired due to limited walking ability, shortness of breath, and claudication. In addition, it is well known that risk factors such as smoking, diabetes mellitus, hypertension, and dyslipidemia can play a role in the onset of this disease

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Control Group for Fitbit Sub-Study
Patient will be given Fitbit device, but will have no access to Fitbit website or interface. The coordinator will set up the patient's Fitbit on the office computer and will have access to the fitbit's associated username and password (this will be generated by the coordinator). The patient will be instructed to walk as much as they can each day, and to check the Fitbit wrist band periodically throughout the day to view their walking progress. At the end of the three month intervention, the patient will complete questionnaires and undergo a repeat 6 minute walk test.
Device: Fitbit Sub-Study
Intervention Group for Fitbit Sub-Study
Patient will be given the Fitbit device and instructed on how to use it. They will be given their username and password to the Fitbit device, and instructed on how to interact with other patients in the study as well as the coordinator on the Fitbit website. The coordinator will also show the patient how to install the application on a smart phone device and use the device via smartphone. The patient will then be instructed to walk as far as they can each day for a period of 12 weeks. Patients will check their steps daily and interact with other patients who participate in the study. Patients will return for a 3 month follow-up appointment where they will undergo a redo 6 minute walk test and questionnaires.
Device: Fitbit Sub-Study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Registry creation of patients with known PAD
Time Frame: 10 Years
Patients will be recruited from the University of Pennsylvania Health System via surveying of physician's clinics and various databases. Appropriate clinical staff will be informed of this study and its requirements prior to a patient's enrollment. As a result, routine care or other medical procedures of the patient will not be interfered with.
10 Years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient walking distance
Time Frame: 1 Year
Patients enrolled in the optional sub-study concerning the use of activity monitoring will be randomized into one of two groups. Those patients randomized into the intervention group, with close monitoring, will exhibit increased motivation for activity and walk farther on their follow-up visit. This will be demonstrated by an increased number of laps walked at their 3 month follow-up visit. Additionally, these subjects would also exhibit increased flow as determined by their ultrasound at their yearly follow-up visit. This would be a result of increased motivation and tolerance for exercise and activity.
1 Year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Genetic and Vascular Testing of Patients
Time Frame: 10 Years
Analysis: After overnight fasting, each patient will donate approximately 10 mLs of venous blood. Blood draws will be done on all patients and will look for genetic and vascular biomarkers that could contribute to progression of the disease. As stated, we are not searching for any new genes in individuals, but rather genetic trends in a large population. Blood will be drawn in plastic, sodium citrate tubes used for microparticles. These tubes will be spun at 2,500g x 15 minutes at room temperature. Closely monitoring these trends will help us define genetic alterations that could lead to the progression of disease.
10 Years
Systematically Monitoring Patients
Time Frame: 10 Years
Following enrollment into the study, patients will be systematically monitored for the entirety of the study. As stated, this will be conducted by annual visits the patients will undergo. These visits, in coordination with the procedures associated with them, will allow us to properly evaluate the progression of disease in these patients. Moreover, the questionnaires that will be conducted at 6 month intervals will ask patients about their overall quality of life and adverse events that may have occurred in the interim period. In doing so, we will be able to systematically monitor the progression of peripheral artery disease longitudinally in a large population, allowing us to draw conclusions as to the onset and time frame of adverse events.
10 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emile R Mohler, MD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 817194

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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