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

Last updated: January 8, 2025
Sponsor: University of West Florida
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Vascular Diseases

Claudication

Circulation Disorders

Treatment

Control group

Revascularization operation

Clinical Study ID

NCT04089943
2211301
1R01AG064420
  • Ages > 30
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. male or female 30 years or older,

  2. Infrainguinal PAD,

  3. critical limb ischemia, defined as arterial insufficiency with gangrene, nonhealingischemic ulcer, or rest pain consistent,

  4. candidate for both endovascular and open infra-inguinal revascularization as judgedby the vascular surgeons,

  5. absence of musculoskeletal (most commonly arthritis related) or neurologic (mostcommonly back pain and sciatica related) symptoms,

  6. willingness to comply with protocol, attend follow-up appointments, complete allstudy assessments, and provide written informed consent.

Exclusion

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 acutetrauma,

  3. current chemotherapy or radiation therapy

Study Design

Total Participants: 230
Treatment Group(s): 2
Primary Treatment: Control group
Phase:
Study Start date:
September 15, 2019
Estimated Completion Date:
August 25, 2025

Study 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.

Connect with a study center

  • Capital Regional Medical Center

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • University of Nebraska at Medical Center

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • UT Austing Dell Medical School

    Austin, Texas 78712
    United States

    Site Not Available

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Baylor Scott and White

    Temple, Texas 76508
    United States

    Site Not Available

  • Baylor Scott and White Hospital

    Temple, Texas 76508
    United States

    Site Not Available

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