VascTrac Peripheral Arterial Disease (PAD) Study

NCT03048890 | Unknown

• 1 other identifier: AAL0001ARG
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

VascTrac is a mobile medical application that tracks users' physical activity levels in order to predict endovascular failure of patients with Peripheral Artery Disease.

Conditions

Peripheral Artery Disease; Intermittent Claudication

Keywords

PAD

Outcome Measures

Primary Outcomes (1)

• Physical Activity

  Participants will have their physical activity measured and recorded by the devices in Apple's Health application.

  Two Years

Study Arms (2)

Patients with PAD

Patients with PAD will be in 1 cohort and will have their physical activity levels closely monitored by researchers and physicians.

Behavioral: Physical activity levels

Patients without PAD

Patients without PAD will be allowed to contribute their data to the application, but they will not be as closely monitored.

Behavioral: Physical activity levels

Interventions

Physical activity levels BEHAVIORAL

Patients with severely low physical activity levels will be notified to consult their physician.

Patients with PAD; Patients without PAD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adults with an iPhone 5s or higher who can read English

You may qualify if:

• adult, has iPhone 5s, can read English

You may not qualify if:

• under 18 years

Sponsors & Collaborators

• Palo Alto Veterans Institute for Research: lead
• W.L.Gore & Associates: collaborator
• Abbott: collaborator
• Cook Group Incorporated: collaborator
• Boston Scientific Corporation: collaborator

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

RECRUITING

Related Publications (9)

• Cunningham MA, Swanson V, Pappas E, O'Carroll RE, Holdsworth RJ. Illness beliefs and walking behavior after revascularization for intermittent claudication: a qualitative study. J Cardiopulm Rehabil Prev. 2014 May-Jun;34(3):195-201. doi: 10.1097/HCR.0000000000000046.

  PMID: 24603143 BACKGROUND

• Carter T, O'Neill S, Johns N, Brady RR. Contemporary vascular smartphone medical applications. Ann Vasc Surg. 2013 Aug;27(6):804-9. doi: 10.1016/j.avsg.2012.10.013. Epub 2013 Mar 25.

  PMID: 23535521 BACKGROUND

• Coughlin PA, Kent PJ, Turton EP, Byrne P, Berridge DC, Scott DJ, Kester RC. A new device for the measurement of disease severity in patients with intermittent claudication. Eur J Vasc Endovasc Surg. 2001 Dec;22(6):516-22. doi: 10.1053/ejvs.2001.1528.

  PMID: 11735200 BACKGROUND

• Gernigon M, Le Faucheur A, Fradin D, Noury-Desvaux B, Landron C, Mahe G, Abraham P. Global positioning system use in the community to evaluate improvements in walking after revascularization: a prospective multicenter study with 6-month follow-up in patients with peripheral arterial disease. Medicine (Baltimore). 2015 May;94(18):e838. doi: 10.1097/MD.0000000000000838.

  PMID: 25950694 BACKGROUND

• Afaq A, Patel JH, Gardner AW, Hennebry TA. Predictors of change in walking distance in patients with peripheral arterial disease undergoing endovascular intervention. Clin Cardiol. 2009 Sep;32(9):E7-11. doi: 10.1002/clc.20553.

  PMID: 19645033 BACKGROUND

• Malgor RD, Alahdab F, Elraiyah TA, Rizvi AZ, Lane MA, Prokop LJ, Phung OJ, Farah W, Montori VM, Conte MS, Murad MH. A systematic review of treatment of intermittent claudication in the lower extremities. J Vasc Surg. 2015 Mar;61(3 Suppl):54S-73S. doi: 10.1016/j.jvs.2014.12.007. Epub 2015 Feb 23.

  PMID: 25721067 BACKGROUND

• Murphy TP, Hirsch AT, Ricotta JJ, Cutlip DE, Mohler E, Regensteiner JG, Comerota AJ, Cohen DJ; CLEVER Steering Committee. The Claudication: Exercise Vs. Endoluminal Revascularization (CLEVER) study: rationale and methods. J Vasc Surg. 2008 Jun;47(6):1356-63. doi: 10.1016/j.jvs.2007.12.048. Epub 2008 Apr 25.

  PMID: 18440181 BACKGROUND

• Murphy TP, Cutlip DE, Regensteiner JG, Mohler ER, Cohen DJ, Reynolds MR, Massaro JM, Lewis BA, Cerezo J, Oldenburg NC, Thum CC, Goldberg S, Jaff MR, Steffes MW, Comerota AJ, Ehrman J, Treat-Jacobson D, Walsh ME, Collins T, Badenhop DT, Bronas U, Hirsch AT; CLEVER Study Investigators. Supervised exercise versus primary stenting for claudication resulting from aortoiliac peripheral artery disease: six-month outcomes from the claudication: exercise versus endoluminal revascularization (CLEVER) study. Circulation. 2012 Jan 3;125(1):130-9. doi: 10.1161/CIRCULATIONAHA.111.075770. Epub 2011 Nov 16.

  PMID: 22090168 BACKGROUND

• Murphy TP, Hirsch AT, Cutlip DE, Regensteiner JG, Comerota AJ, Mohler E, Cohen DJ, Massaro J; CLEVER Investigators. Claudication: exercise vs endoluminal revascularization (CLEVER) study update. J Vasc Surg. 2009 Oct;50(4):942-945.e2. doi: 10.1016/j.jvs.2009.04.076. Epub 2009 Aug 5.

  PMID: 19660897 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Oliver O Aalami, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver O Aalami, MD

CONTACT

650-852-3451; aalami@stanford.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: February 9, 2017
• Study Start: March 1, 2017
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 3, 2022

Record last verified: 2022-11

Locations

US (1)