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The Role of microRNA-210 in Regulating Oxidative Stress in Patients With PAD

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ClinicalTrials.gov Identifier: NCT04089943
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Panagiotis Koutakis, Florida State University

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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Vascular Diseases, Peripheral Arterial Occlusive Diseases Atherosclerosis Procedure: Revascularization operation Other: Control group Not Applicable

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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Control group
Healthy non-PAD participants will be recruited as control group
Other: Control group
Healthy non-PAD participants will be recruited for the study.




Primary Outcome Measures :
  1. miR-210 gene expression [ Time Frame: Change from baseline to six-month follow-up ]
    Measure miR-210 gene expression at baseline and after intervention

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. The 36-Item Short Form questionnaire [ 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.

  4. The Walking Impairment Questionnaire [ Time Frame: Change from baseline to six-month follow-up ]
    The well validated Walking Impairment Questionnaire will be used to measure patient- perceived walking performance.



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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, and
  4. chronic kidney disease with estimated Glomerular Filtration Rate <30nl/min/1.73m2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04089943


Contacts
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Contact: Panagiotis Koutakis, PhD 850-644-1829 pkoutakis@fsu.edu

Locations
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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         
Sponsors and Collaborators
Florida State University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Panagiotis Koutakis, PhD Florida State University

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Responsible Party: Panagiotis Koutakis, Assistant Professor, Florida State University
ClinicalTrials.gov Identifier: NCT04089943     History of Changes
Other Study ID Numbers: STUDY00000272
1R01AG064420 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Panagiotis Koutakis, Florida State University:
peripheral artery disease
microRNA
Additional relevant MeSH terms:
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Atherosclerosis
Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases