The Impact of Branched-Chain Amino Acid Metabolism on Limb Dysfunction in PAD
Primary Purpose
Peripheral Arterial Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supervised Exercise
Vascular Assessment
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease
Eligibility Criteria
Inclusion/exclusion criteria for Healthy Subjects
Inclusion criteria
- Male or female, age ≥ 50 years old
- Non-smoker
Exclusion criteria
- Presence of peripheral artery disease
- History of a heart attack or stroke
- Diabetes
- Active cancer
- Severe renal disease (CrCl < 60)
- Severe liver disease
- Active rheumatological diseases
Inclusion/exclusion criteria for PAD Subjects
Inclusion criteria
- 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
Exclusion criteria
- 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.
Sites / Locations
- Vanderbilt University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Active Comparator
Arm Label
Healthy Subjects
Peripheral Artery Disease (PAD) with Supervised Exercise
PAD Subjects Who Undergo Revascularization of the Leg
Arm Description
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.
This group of subjects are receiving leg revascularization as part of standard of care.
Outcomes
Primary Outcome Measures
C3/C5acylcarnitine levels in healthy control subjects.
C3/C5acylcarnitine levels in PAD exercise group after 12 weeks
C3/C5 acylcarnitine levels in PAD surgical bypass group
Secondary Outcome Measures
Full Information
NCT ID
NCT03490968
First Posted
March 30, 2018
Last Updated
August 2, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
American Heart Association
1. Study Identification
Unique Protocol Identification Number
NCT03490968
Brief Title
The Impact of Branched-Chain Amino Acid Metabolism on Limb Dysfunction in PAD
Official Title
The Impact of Branched-Chain Amino Acid Metabolism on Limb Dysfunction in PAD (MicroPAD)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2018 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
American Heart Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy Subjects
Arm Type
Other
Arm Title
Peripheral Artery Disease (PAD) with Supervised Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
PAD Subjects Who Undergo Revascularization of the Leg
Arm Type
Active Comparator
Arm Description
This group of subjects are receiving leg revascularization as part of standard of care.
Intervention Type
Behavioral
Intervention Name(s)
Supervised Exercise
Intervention Description
Subjects will have 3 visits per week for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Vascular Assessment
Intervention Description
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.
Primary Outcome Measure Information:
Title
C3/C5acylcarnitine levels in healthy control subjects.
Time Frame
baseline
Title
C3/C5acylcarnitine levels in PAD exercise group after 12 weeks
Time Frame
Change from baseline to 12 weeks
Title
C3/C5 acylcarnitine levels in PAD surgical bypass group
Time Frame
Change from baseline to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion/exclusion criteria for Healthy Subjects
Inclusion criteria
Male or female, age ≥ 50 years old
Non-smoker
Exclusion criteria
Presence of peripheral artery disease
History of a heart attack or stroke
Diabetes
Active cancer
Severe renal disease (CrCl < 60)
Severe liver disease
Active rheumatological diseases
Inclusion/exclusion criteria for PAD Subjects
Inclusion criteria
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
Exclusion criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cassandra Reynolds, BS
Phone
6158759854
Email
cassandra.f.reynolds@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Beckman, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Shardelow, BS
First Name & Middle Initial & Last Name & Degree
Joshua Beckman, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Impact of Branched-Chain Amino Acid Metabolism on Limb Dysfunction in PAD
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