Atherosclerosis Clinical Trial
Official title:
The Role of microRNA-210 in Regulating Oxidative Stress in Patients With Peripheral Artery Disease
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.
Status | Recruiting |
Enrollment | 230 |
Est. completion date | March 31, 2024 |
Est. primary completion date | March 29, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Baylor Scott and White Hospital | Temple | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor University | National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | miR-210 gene expression | Measure miR-210 gene expression at baseline and after intervention | Change from baseline to six-month follow-up | |
Primary | Calf muscle biopsy biochemical measures | A skeletal muscle sample will be obtained from the gastrocnemius muscle. | Change from baseline to six-month follow-up | |
Secondary | Six-minute walk performance | 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 | Change from baseline to six-month follow-up | |
Secondary | Graded treadmill walk performance | 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. | Change from baseline to six-month follow-up | |
Secondary | The 36-Item Short Form questionnaire (SF-36) | 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. | Change from baseline to six-month follow-up | |
Secondary | The Walking Impairment Questionnaire | 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. | Change from baseline to six-month follow-up |
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