The Role of microRNA-210 in Regulating Oxidative Stress in Patients With PAD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04089943|
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : September 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease Vascular Diseases, Peripheral Arterial Occlusive Diseases Atherosclerosis||Procedure: Revascularization operation Other: Control group||Not Applicable|
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 planing 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Role of microRNA-210 in Regulating Oxidative Stress in Patients With Peripheral Artery Disease|
|Estimated Study Start Date :||September 15, 2019|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||March 31, 2024|
Experimental: Revascularization group
Participants will be randomized to either an endovascular or an open bypass procedure.
Procedure: Revascularization operation
Participants will be randomized into an endovascular or open bypass procedure.
Healthy non-PAD participants will be recruited as control group
Other: Control group
Healthy non-PAD participants will be recruited for the study.
- miR-210 gene expression [ Time Frame: Change from baseline to six-month follow-up ]Measure miR-210 gene expression at baseline and after intervention
- Calf muscle biopsy biochemical measures [ Time Frame: Change from baseline to six-month follow-up ]A skeletal muscle sample will be obtained from the gastrocnemius muscle.
- Six-minute walk performance [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04089943
|Contact: Panagiotis Koutakis, PhDemail@example.com|
|United States, Florida|
|Capital Regional Medical Center||Recruiting|
|Tallahassee, Florida, United States, 32308|
|Contact: Jeffrey Kirk, MD|
|United States, Texas|
|Baylor Scott and White Hospital||Recruiting|
|Temple, Texas, United States, 76508|
|Contact: William T Bohannon, MD|
|Principal Investigator:||Panagiotis Koutakis, PhD||Florida State University|