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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG064420 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Revascularization group | Experimental | Participants will be randomized to either an endovascular or an open bypass procedure. |
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| Control group | Other | Healthy non-PAD participants will be recruited as control group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revascularization operation | Procedure | Participants will be randomized into an endovascular or open bypass procedure. |
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| Measure | Description | Time Frame |
|---|---|---|
| miR-210 gene expression | Measure miR-210 gene expression at baseline and after intervention | Change from baseline to six-month follow-up |
| Calf muscle biopsy biochemical measures | A skeletal muscle sample will be obtained from the gastrocnemius muscle. | Change from baseline to six-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Graded treadmill walk performance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Panagiotis Koutakis, PhD | University of West Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Austing Dell Medical School | Austin | Texas | 78712 | United States | ||
| Baylor Scott and White |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D016491 | Peripheral Vascular Diseases |
| D001157 | Arterial Occlusive Diseases |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control group | Other | Healthy non-PAD participants will be recruited for the study. |
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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 |
| 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 |
| 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 |
| Temple |
| Texas |
| 76508 |
| United States |
| D008722 | Methods |