Arterial Occlusive Diseases, Atherosclerosis, Peripheral Arterial Disease, Vascular Diseases, Peripheral
Conditions
Keywords
peripheral artery disease, microRNA
Brief summary
MicroRNA-210 (miR-210) can be a potential therapeutic target of patients with peripheral artery disease (PAD). Recent evidence suggests the role of miR-210 and oxidative stress in the pathophysiology of PAD and its association with mitochondrial function, oxidative metabolism, walking distances and quality of life. The protocol evaluates the mechanisms which miR-210 regulates oxidative stress and provides evidence of potential therapeutic strategies.
Detailed description
The investigators will randomize 180 PAD patients that undergoing a revascularization operation in two groups: (1) an endovascular procedure or (2) an open bypass procedure. They are also planning to recruit 50 non-PAD healthy control subjects. The goal is to answer the main hypothesis that miR-210 gene expression is a master regulator of oxidative stress and is associated with mitochondrial dysfunction, oxidative metabolism, walking function and quality of life.
Interventions
PROCEDURERevascularization operation
Participants will be randomized into an endovascular or open bypass procedure.
OTHERControl group
Healthy non-PAD participants will be recruited for the study.
Sponsors
University of West Florida
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. male or female 30 years or older, 2. Infrainguinal PAD, 3. critical limb ischemia, defined as arterial insufficiency with gangrene, nonhealing ischemic ulcer, or rest pain consistent, 4. candidate for both endovascular and open infra-inguinal revascularization as judged by the vascular surgeons, 5. absence of musculoskeletal (most commonly arthritis related) or neurologic (most commonly back pain and sciatica related) symptoms, 6. willingness to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent.
Exclusion criteria
1. life expectancy of less than 2 years due to reasons other than PAD, 2. acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma, 3. current chemotherapy or radiation therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| miR-210 gene expression | Change from baseline to six-month follow-up | Measure miR-210 gene expression at baseline and after intervention |
| Calf muscle biopsy biochemical measures | Change from baseline to six-month follow-up | A skeletal muscle sample will be obtained from the gastrocnemius muscle. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six-minute walk performance | Change from baseline to six-month follow-up | Participants walking up and down a 100 foot hallway for six minutes following a standardized protocol. The goal is for them to walk as far as possible in six minutes |
| Graded treadmill walk performance | Change from baseline to six-month follow-up | Participants walking on treadmill following a standardized protocol. The goal is for them to walk as far as possible while the treadmill incline increases every 2 minutes. |
| The 36-Item Short Form questionnaire (SF-36) | Change from baseline to six-month follow-up | This well validated quality of life measure will be used to assess changes in patient perceived quality of life. The SF-36 is scored from 0-100, with 100 being the best score. |
| The Walking Impairment Questionnaire | Change from baseline to six-month follow-up | The well validated Walking Impairment Questionnaire (WIQ) will be used to measure patient- perceived walking performance. The WIQ is scored from 0-100, with 100 being the best score. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPanagiotis Koutakis, PhD
University of West Florida
Outcome results
None listed