Peripheral Arterial DiseaseNCT03490968
The Impact of Branched-Chain Amino Acid Metabolism on Limb Dysfunction in PAD
A study testing Supervised Exercise and Vascular Assessment in people with Peripheral Arterial Disease, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Test the theory that abnormalities in the large blood vessels that deliver blood to your leg and the very small blood vessels in your leg's muscles (invisible to the eye) work together to worsen your leg function and walking. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Supervised Exercise and Vascular Assessment
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2018to 22 Aug 2023
- Phase
- Interventional
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, age ≥ 50 years old
- Non-smoker
- Male or female, age 50 years or older
- Atherosclerotic PAD, ABI ≤0.85
- Willing to comply with protocol, attend follow-up appointments, complete all study assessments, and provide informed consent
- For Aim 3, subjects will have Rutherford stage 4 or 5 disease
- For Aim 3, subjects will be undergoing revascularization as standard of care
Who cannot join
- Presence of peripheral artery disease
- History of a heart attack or stroke
- Diabetes
- Active cancer
- Severe renal disease (CrCl < 60)
- Severe liver disease
Show all 24Show fewer
- Active rheumatological diseases
- Presence of a femoral, popliteal or tibial aneurysm of the index limb
- Life expectancy less than 2 years
- A vascular disease prognosis that includes an anticipated above ankle amputation on index limb within 4 weeks of index procedure
- Renal dysfunction defined as MDRD eGFR ≤ 20ml/min/173 m2 at the time of screening
- Currently on dialysis or history of a renal transplant
- Cirrhosis or active hepatitis
- A documented hypercoagulable state
- Myocardial infarction within 6 months
- Stroke within 6 months
- Nonatherosclerotic occlusive disease of the lower extremity
- Any prior infrainguinal revascularization on index limb
- Current immunosuppressive medication, chemotherapy or radiation therapy
- Inability to have an MRI
- Exercise limitation aside from that due to PAD (i.e. COPD, degenerative joint disease, etc.)
- Women who are pregnant
- Women who are nursing
- Primary indications for systemic oral anticoagulation for active arterial or venous thromboembolic disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: The Impact of Branched-Chain Amino Acid Metabolism on Limb Dysfunction in PAD (MicroPAD)
Test the theory that abnormalities in the large blood vessels that deliver blood to your leg and the very small blood vessels in your leg's muscles (invisible to the eye) work together to worsen your leg function and walking.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Supervised Exercise, Vascular Assessment
- 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.
Supervised ExerciseBehavioural
Subjects will have 3 visits per week for 12 weeks.
Vascular AssessmentBehavioural
Screen: Subjects will undergo a H\&P, ankle brachial index, ECG, CBC, CMP, lipid panel, HgA1C, and urinalysis. A urine pregnancy test will be performed on women of childbearing age.
Testing Visit 1: MRI, IV in common femoral vein with phlebotomy (60 cc total) before and after sphygmomanometric cuff occlusion of lower limb, 6-minute walk test, 4-meter walk speed test, walking impairment questionnaire, and muscle biopsy.
Supervised exercise and leg revascularization patients will return in 12 weeks and have the same study procedures as testing visit 1, plus an ankle brachial index, repeated.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Other | Not described Receives: Behavioral: Vascular Assessment |
| Peripheral Artery Disease (PAD) with Supervised Exercise | Experimental | Subjects will be referred for supervised exercise therapy. Subjects will have 3 visits per week for 12 weeks. Each visit will include a minimum of 30 to 40 minutes of exercise to improve ambulation with a certified trainer. Receives: Behavioral: Supervised Exercise; Behavioral: Vascular Assessment |
| PAD Subjects Who Undergo Revascularization of the Leg | Active comparator | This group of subjects are receiving leg revascularization as part of standard of care. Receives: Behavioral: Vascular Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
C3/C5acylcarnitine levels in healthy control subjects.
Measured: baseline
C3/C5acylcarnitine levels in PAD exercise group after 12 weeks
Measured: Change from baseline to 12 weeks
C3/C5 acylcarnitine levels in PAD surgical bypass group
Measured: Change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start22 May 2018
- Primary completion22 Aug 2023
- Study completion22 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Joshua Beckman, Vanderbilt University Medical Center
- Investigators
- Joshua Beckman, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490968
- Sponsor's protocol ID
- 180441
- Other IDs
- 18SFRN33900069
- Status last verified
- Feb 2024
- First submitted
- 30 Mar 2018
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sullivan AE, Behroozian A, Coolbaugh C, Shardelow E, Smith EK, Wells QS, Clair DG, Aday AW, Garrard CL 3rd, Curci JA, Holder TA, Barnett JV, Freiberg MS, Crescenzi RL, Wakeham DJ, Hearon CM Jr, Donahue MJ, Beckman JA. Microvascular Function and Ambulatory Capacity in Peripheral Artery Disease. Circ Cardiovasc Interv. 2025 Oct;18(10):e015582. doi: 10.1161/CIRCINTERVENTIONS.125.015582. Epub 2025 Sep 4.
PubMed 40905129
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Branched-Chain Amino Acid Metabolism on Limb Dysfunction in PAD (MicroPAD)
- ClinicalTrials.gov ID
- NCT03490968
- Acronym / sponsor ID
- 180441
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 22 May 2018 (actual)
- Primary completion
- 22 Aug 2023 (actual)
- Study completion
- 22 Aug 2023 (actual)
- First posted
- 6 Apr 2018 (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.
Test the theory that abnormalities in the large blood vessels that deliver blood to your leg and the very small blood vessels in your leg's muscles (invisible to the eye) work together to worsen your leg function and walking.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | Other | Behavioral: Vascular Assessment |
| Peripheral Artery Disease (PAD) with Supervised Exercise | Experimental | Behavioral: Supervised Exercise, Behavioral: Vascular AssessmentSubjects will be referred for supervised exercise therapy. Subjects will have 3 visits per week for 12 weeks. Each visit will include a minimum of 30 to 40 minutes of exercise to improve ambulation with a certified trainer. |
| PAD Subjects Who Undergo Revascularization of the Leg | Active comparator | Behavioral: Vascular AssessmentThis group of subjects are receiving leg revascularization as part of standard of care. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, age ≥ 50 years old
- Non-smoker
- Male or female, age 50 years or older
- Atherosclerotic PAD, ABI ≤0.85
- Willing to comply with protocol, attend follow-up appointments, complete all study assessments, and provide informed consent
Key exclusion criteria (24 listed)
- Presence of peripheral artery disease
- History of a heart attack or stroke
- Diabetes
- Active cancer
- Severe renal disease (CrCl < 60)
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 |
|---|---|---|
| Supervised ExerciseSubjects will have 3 visits per week for 12 weeks. | Behavioural | Peripheral Artery Disease (PAD) with Supervised Exercise |
| Vascular AssessmentScreen: Subjects will undergo a H\&P, ankle brachial index, ECG, CBC, CMP, lipid panel, HgA1C, and urinalysis. A urine pregnancy test will be performed on women of childbearing age. Testing Visit 1: MRI, IV in common femoral vein with phlebotomy (60 cc total) before and after sphygmomanometric cuff occlusion of lower limb, 6-minute walk test, 4-meter walk speed test, walking impairment questionnaire, and muscle biopsy. Supervised exercise and leg revascularization patients will return in 12 weeks and have the same study procedures as testing visit 1, plus an ankle brachial index, repeated. | Behavioural | Healthy Subjects, PAD Subjects Who Undergo Revascularization of the Leg, Peripheral Artery Disease (PAD) with Supervised Exercise |
Primary outcome
C3/C5acylcarnitine levels in healthy control subjects.
Time frame: baseline
C3/C5acylcarnitine levels in PAD exercise group after 12 weeks
Time frame: Change from baseline to 12 weeks
C3/C5 acylcarnitine levels in PAD surgical bypass group
Time frame: Change from baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Derived from this study: PubMed 40905129Sullivan AE, Behroozian A, Coolbaugh C, Shardelow E, Smith EK, Wells QS, Clair DG, Aday AW, Garrard CL 3rd, Curci JA, Holder TA, Barnett JV, Freiberg MS, Crescenzi RL, Wakeham DJ, Hearon CM Jr, Donahue MJ, Beckman JA. Microvascular Function and Ambulatory Capacity in Peripheral Artery Disease. Circ Cardiovasc Interv. 2025 Oct;18(10):e015582. doi: 10.1161/CIRCINTERVENTIONS.125.015582. Epub 2025 Sep 4.
- Individual participant dataSharing planned: Undecided
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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.
Joshua Beckman, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Exercise and Vascular Assessment in people with Peripheral Arterial Disease, run by Vanderbilt University Medical Center 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 7 inclusion and 24 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: finished, as of the sponsor's last update on 29 Feb 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
C3/C5acylcarnitine levels in healthy control subjects. (time frame: baseline). The study lists 3 primary outcomes in all. 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 NCT03490968, which also lists 1 linked publication.
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 29 Feb 2024.