Peripheral Artery DiseaseNCT05063474
Microvascular Reactivity in Peripheral Artery Disease
An observational study of Peripheral Artery Disease, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Peripheral Artery Disease
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2021to 24 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Microvascular Reactivity in People With Peripheral Artery Disease: a Pilot Study to Determine Reliability, Validity, and Sensitivity to Change
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.
Read the detailed description
Subjects: Subjects with peripheral artery disease (PAD) with or without lower limb amputation will be recruited from 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. All subjects will be 35-80 years old at risk for amputation as determined by meeting any of the following criteria. 1) People with peripheral artery disease diagnosed by ankle-brachial index (ABI) <0.9 or 1.4. 2) People who have a history of endovascular or surgical revascularization for critical ischemia, or 3) People with previous major or minor unilateral lower limb loss due to PAD, with or without diabetes. Once informed written consent has been obtained Assessment sessions will depend on group assignment.
The PLL+PAD group will attend 2 assessment sessions: initial and 1-month follow-up assessments only. The PLL+PAD group will receive no intervention. However, a monitor will be used to remotely assess their general walking activity. At the end of the initial assessment, PLL will have daily step count assessed with a StepWatch4 step activity monitor strapped just above the lateral prosthetic ankle. The average daily step count will be derived from the last full week of 24- hour/day data collection closest in time to the next assessment, at which time the StepWatch4 will be removed. Between sessions, subjects will be encouraged to continue their usual activities; no directions regarding exercise, physical activity, or walking will be given. Data from the two sessions will be used to determine test-retest reliability (Aim 1). Near infrared spectrometry measurement data from the 1st session will be used to determine associations with walking performance measures (Aim 2).
The PAD group will attend 3 assessment sessions: initial, 1-month, and 2-month follow-up assessments. The PAD group will already be enrolled in a PAD rehabilitation program-independent of this research program-that consists of 2-3 times per week 1-hour sessions. Sessions include progressive treadmill training for 30- minute-including rest breaks as needed-with inclination added if tolerated. Also included is 30-minutes of calf and hamstring stretching and general strengthening including free weights for the upper limbs, cuff weights for the lower limbs, and repeated sit-to-stand and step functional training. The rehabilitation program consists of 24 sessions over 2 months and the number of sessions attended will be counted. If subjects opt for an additional 1-month of training session, they will undergo a 3-month follow-up assessment. Repeated measures data from the PAD group will be used to determine effect size change of the primary outcome measures (Aim 3).
Measures: All subjects at each session will complete a questionnaire and undergo clinical assessments. Follow up calls every 6 months will be made to determine medical outcome.
Questionnaire data will include individual characteristics, medical history, and self-report claudication scale. General health perception will be assessed with SF-12.
Clinical assessment will occur at each session and include vital signs, ankle brachial index, near infrared spectrometry during strength and walking assessments. General lower extremity strength will be assessed with heel raises up to 25 repetitions and the 30-sec sit-to-stand. Walking performance will be assessed using the 6-Minute Walk Test using a standard 20m walkway with rests allowed as needed. Walking speed will be obtained from the first 20m. Clinical assessment of strength and walking are expected to be of moderate intensity.
Statistical analysis will include group descriptions, Intraclass Correlation Coefficients for test-retest reliability, and Pearson correlation coefficients for convergent or divergent validity between near infrared spectrometry and clinical outcome measures.
- Conditions
- Peripheral Artery Disease
- Being tested
- No Intervention-Clinical Assessments only
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention-Clinical Assessments onlyDiagnostic test
No Intervention. Clinical Assessments include: vital signs, near infrared spectrometry, general leg strength, and 6-minute walking test.
| Study group | Role | What they receive |
|---|---|---|
| PAD: Peripheral Artery Disease | People with Peripheral Artery Disease (PAD). No intervention given, observation and assessment only Receives: 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 Receives: Diagnostic Test: No Intervention-Clinical Assessments only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular Reactivity
Near Infrared Spectrometry
Measured: Monthly: from initial assessment each month for up to 2 months.
Secondary outcomes (4)
6-Minute Walk Test
Distance and speed
Measured: Monthly: from initial assessment each month for up to 2 months.
Claudication
Time to onset and severity
Measured: Monthly: from initial assessment each month for up to 2 months.
General Lower-Limb Strength
30s Sit-to-Stand test
Measured: Monthly: from initial assessment each month for up to 2 months.
Calf muscle strength
Repetitive heel raises (up to 25 max)
Measured: Monthly: from initial assessment each month for up to 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start9 Nov 2021
- Primary completion24 Apr 2023
- Study completion24 Apr 2023
Why it stopped: Poor enrollment and lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Christopher K Wong, PhD, PT, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063474
- Sponsor's protocol ID
- AAAT5119
- Other IDs
- R01HS025198
- Status last verified
- May 2024
- First submitted
- 9 Sep 2021
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32580632Vieira 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.
PubMed 31077636Duscha 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.
PubMed 30049464Behroozian 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.
PubMed 32075418Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res. 2015 Apr 24;116(9):1509-26. doi: 10.1161/CIRCRESAHA.116.303849.
PubMed 25908725Olin 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.
PubMed 26988957Jones 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.
PubMed 27942271
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvascular Reactivity in People With Peripheral Artery Disease: a Pilot Study to Determine Reliability, Validity, and Sensitivity to Change
- ClinicalTrials.gov ID
- NCT05063474
- Acronym / sponsor ID
- AAAT5119
- Conditions
- Peripheral Artery Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor enrollment and lack of funding
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects: Subjects with peripheral artery disease (PAD) with or without lower limb amputation will be recruited from 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. All subjects will be 35-80 years old at risk for amputation as determined by meeting any of the following criteria. 1) People with peripheral artery disease diagnosed by ankle-brachial index (ABI) <0.9 or 1.4. 2) People who have a history of endovascular or surgical revascularization for critical ischemia, or 3) People with previous major or minor unilateral lower limb loss due to PAD, with or without diabetes. Once informed written consent has been obtained Assessment sessions will depend on group assignment.
The PLL+PAD group will attend 2 assessment sessions: initial and 1-month follow-up assessments only. The PLL+PAD group will receive no intervention. However, a monitor will be used to remotely assess their general walking activity. At the end of the initial assessment, PLL will have daily step count assessed with a StepWatch4 step activity monitor strapped just above the lateral prosthetic ankle. The average daily step count will be derived from the last full week of 24- hour/day data collection closest in time to the next assessment, at which time the StepWatch4 will be removed. Between sessions, subjects will be encouraged to continue their usual activities; no directions regarding exercise, physical activity, or walking will be given. Data from the two sessions will be used to determine test-retest reliability (Aim 1). Near infrared spectrometry measurement data from the 1st session will be used to determine associations with walking performance measures (Aim 2).
The PAD group will attend 3 assessment sessions: initial, 1-month, and 2-month follow-up assessments. The PAD group will already be enrolled in a PAD rehabilitation program-independent of this research program-that consists of 2-3 times per week 1-hour sessions. Sessions include progressive treadmill training for 30- minute-including rest breaks as needed-with inclination added if tolerated. Also included is 30-minutes of calf and hamstring stretching and general strengthening including free weights for the upper limbs, cuff weights for the lower limbs, and repeated sit-to-stand and step functional training. The rehabilitation program consists of 24 sessions over 2 months and the number of sessions attended will be counted. If subjects opt for an additional 1-month of training session, they will undergo a 3-month follow-up assessment. Repeated measures data from the PAD group will be used to determine effect size change of the primary outcome measures (Aim 3).
Measures: All subjects at each session will complete a questionnaire and undergo clinical assessments. Follow up calls every 6 months will be made to determine medical outcome.
Questionnaire data will include individual characteristics, medical history, and self-report claudication scale. General health perception will be assessed with SF-12.
Clinical assessment will occur at each session and include vital signs, ankle brachial index, near infrared spectrometry during strength and walking assessments. General lower extremity strength will be assessed with heel raises up to 25 repetitions and the 30-sec sit-to-stand. Walking performance will be assessed using the 6-Minute Walk Test using a standard 20m walkway with rests allowed as needed. Walking speed will be obtained from the first 20m. Clinical assessment of strength and walking are expected to be of moderate intensity.
Statistical analysis will include group descriptions, Intraclass Correlation Coefficients for test-retest reliability, and Pearson correlation coefficients for convergent or divergent validity between near infrared spectrometry and clinical outcome measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAD: Peripheral Artery Disease | – | Diagnostic Test: No Intervention-Clinical Assessments onlyPeople with Peripheral Artery Disease (PAD). No intervention given, observation and assessment only |
| PLL+PAD: People with Limb Loss and Peripheral Artery Disease | – | Diagnostic Test: No Intervention-Clinical Assessments onlyPeople with Lower-Limb Loss (PLL) and Peripheral Artery Disease (PAD) No intervention given, observation and assessment only |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention-Clinical Assessments onlyNo Intervention. Clinical Assessments include: vital signs, near infrared spectrometry, general leg strength, and 6-minute walking test. | Diagnostic test | PAD: Peripheral Artery Disease, PLL+PAD: People with Limb Loss and Peripheral Artery Disease |
Primary outcome
Microvascular Reactivity
Time frame: Monthly: from initial assessment each month for up to 2 months.
Near Infrared Spectrometry
4 secondary outcomes
6-Minute Walk Test
Time frame: Monthly: from initial assessment each month for up to 2 months.
Claudication
Time frame: Monthly: from initial assessment each month for up to 2 months.
General Lower-Limb Strength
Time frame: Monthly: from initial assessment each month for up to 2 months.
Calf muscle strength
Time frame: Monthly: from initial assessment each month for up to 2 months.
Results and safety
The study was stopped early (reason given: Poor enrollment and lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Background: PubMed 32580632Barnes 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.
- Background: PubMed 31077636Vieira 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.
- Background: PubMed 30049464Duscha 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.
- Background: PubMed 32075418Behroozian 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.
- Background: PubMed 25908725Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res. 2015 Apr 24;116(9):1509-26. doi: 10.1161/CIRCRESAHA.116.303849.
- Background: PubMed 26988957Olin 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.
- Background: PubMed 27942271Jones 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher K Wong, PhD, PT principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor enrollment and lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvascular Reactivity (time frame: Monthly: from initial assessment each month for up to 2 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05063474, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.