VascTrac Peripheral Arterial Disease (PAD) Study

Peripheral Artery Disease Clinical Trial

— VascTrac  

Official title:

VascTrac PAD ResearchKit Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03048890
• Other study ID #: AAL0001ARG
• Status: Recruiting
• Start date: March 1, 2017
• Est. completion date: December 1, 2023

Study information

• Verified date: November 2022
• Source: Palo Alto Veterans Institute for Research
• Contact: Oliver O Aalami, MD
• Phone: 650-852-3451
• Email: aalami[@]stanford.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

VascTrac uses open-source software from Apple's ResearchKit to passively track physical activity levels of users who sign up. The goal is to predict post-intervention endovascular failure before it occurs. Currently, physicians have no way of knowing when procedures such as angioplasties fail; with VascTrac, researchers hope to find downward trends in physical activity that will predict and indicate endovascular failure. All users are assigned numbers and their medical data is securely coded, decreasing the risk of promulgation of personal information.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult, has iPhone 5s, can read English

Exclusion Criteria:

• under 18 years

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Behavioral:
• Physical activity levels
Patients with severely low physical activity levels will be notified to consult their physician.

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System	Palo Alto	California

Sponsors (5)

Lead Sponsor	Collaborator
Palo Alto Veterans Institute for Research	Abbott, Boston Scientific Corporation, Cook Group Incorporated, Gore

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. Erratum in: J Vasc Surg. 2015 May;61(5):1382. Alalahdab, Fares [Corrected to Alahdab, Fares]. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity	Participants will have their physical activity measured and recorded by the devices in Apple's Health application.	Two Years