Microvascular Reactivity in Peripheral Artery Disease

NCT05063474 | Terminated

• 2 other identifiers: AAAT5119R01HS025198
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Peripheral Artery Disease (PAD) is a major risk factor for lower limb amputation. Microvascular reactivity assessed with near-infrared spectrometry has been studied in people with PAD but not in people with limb loss (PLL) who have PAD. The purpose of this research is to explore whether near-infrared spectrometry measures can contribute to identifying people at risk for amputation. Specific aims include: 1) Determine the test-retest reliability of near-infrared spectrometry measures in people with peripheral artery disease with or without major unilateral amputation. 2) Determine construct validity of near-infrared spectrometry measures compared to 6-Minute Walk Test, and time to claudication onset; and self-reported prosthetic mobility in people with transtibial amputation. This methodologic prospective study with repeated assessments and long term phone follow-up every year to identify any subjects that undergo revascularization or amputation will include 2 groups of subjects: a PAD group enrolled from an out-patient walking program, and a PLL+PAD group who receive no care but have their walking step counts monitored.

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

• Microvascular Reactivity

  Near Infrared Spectrometry

  Monthly: from initial assessment each month for up to 2 months.

Secondary Outcomes (4)

• 6-Minute Walk Test

  Monthly: from initial assessment each month for up to 2 months.

• Claudication

  Monthly: from initial assessment each month for up to 2 months.

• General Lower-Limb Strength

  Monthly: from initial assessment each month for up to 2 months.

• Calf muscle strength

  Monthly: from initial assessment each month for up to 2 months.

Study Arms (2)

PAD: Peripheral Artery Disease

People with Peripheral Artery Disease (PAD). No intervention given, observation and assessment only

Diagnostic Test: No Intervention-Clinical Assessments only

PLL+PAD: People with Limb Loss and Peripheral Artery Disease

People with Lower-Limb Loss (PLL) and Peripheral Artery Disease (PAD) No intervention given, observation and assessment only

Diagnostic Test: No Intervention-Clinical Assessments only

Interventions

No Intervention-Clinical Assessments only DIAGNOSTIC_TEST

No Intervention. Clinical Assessments include: vital signs, near infrared spectrometry, general leg strength, and 6-minute walking test.

PAD: Peripheral Artery Disease; PLL+PAD: People with Limb Loss and Peripheral Artery Disease

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with peripheral artery disease with or without lower limb amputation will be recruited from peripheral artery disease (PAD) rehabilitation programs or support groups for people with limb loss (PLL) in the Columbia University Irving Medical Center system and New York City metropolitan area. Equal numbers (n=10) will be assigned to the people with PAD group and the PLL plus PAD (PLL+PAD) group.

You may qualify if:

• People of any sex or race/culture
• Clinical diagnosed of peripheral artery disease
• People with or without diabetes
• People with or without past endovascular or vascular procedures for peripheral artery disease within the past year
• People who have unilateral minor or major lower limb amputation

You may not qualify if:

• People who cannot communicate in English
• People judged unable to participate due to cognitive limitation or medical instability
• People who cannot walk independently 50 feet, with or without walking aid

Sponsors & Collaborators

• Columbia University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (7)

• Barnes JA, Eid MA, Creager MA, Goodney PP. Epidemiology and Risk of Amputation in Patients With Diabetes Mellitus and Peripheral Artery Disease. Arterioscler Thromb Vasc Biol. 2020 Aug;40(8):1808-1817. doi: 10.1161/ATVBAHA.120.314595. Epub 2020 Jun 25.

  PMID: 32580632 BACKGROUND

• Vieira de Oliveira G, Soares RN, Volino-Souza M, Murias JM, Alvares TS. The association between near-infrared spectroscopy assessment of microvascular reactivity and flow-mediated dilation is disrupted in individuals at high risk for cardiovascular disease. Microcirculation. 2019 Oct;26(7):e12556. doi: 10.1111/micc.12556. Epub 2019 Jun 2.

  PMID: 31077636 BACKGROUND

• Duscha BD, Piner LW, Patel MP, Crawford LE, Jones WS, Patel MR, Kraus WE. Effects of a 12-Week mHealth Program on FunctionalCapacity and Physical Activity in Patients With PeripheralArtery Disease. Am J Cardiol. 2018 Sep 1;122(5):879-884. doi: 10.1016/j.amjcard.2018.05.018. Epub 2018 Jun 2.

  PMID: 30049464 BACKGROUND

• Behroozian A, Beckman JA. Microvascular Disease Increases Amputation in Patients With Peripheral Artery Disease. Arterioscler Thromb Vasc Biol. 2020 Mar;40(3):534-540. doi: 10.1161/ATVBAHA.119.312859. Epub 2020 Feb 20.

  PMID: 32075418 BACKGROUND

• Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res. 2015 Apr 24;116(9):1509-26. doi: 10.1161/CIRCRESAHA.116.303849.

  PMID: 25908725 BACKGROUND

• Olin JW, White CJ, Armstrong EJ, Kadian-Dodov D, Hiatt WR. Peripheral Artery Disease: Evolving Role of Exercise, Medical Therapy, and Endovascular Options. J Am Coll Cardiol. 2016 Mar 22;67(11):1338-57. doi: 10.1016/j.jacc.2015.12.049.

  PMID: 26988957 BACKGROUND

• Jones S, Chiesa ST, Chaturvedi N, Hughes AD. Recent developments in near-infrared spectroscopy (NIRS) for the assessment of local skeletal muscle microvascular function and capacity to utilise oxygen. Artery Res. 2016 Dec;16:25-33. doi: 10.1016/j.artres.2016.09.001.

  PMID: 27942271 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Christopher K Wong, PhD, PT

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: October 1, 2021
• Study Start: November 9, 2021
• Primary Completion: April 24, 2023
• Study Completion: April 24, 2023
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)