Skip to main content
OpenTrials
Completed

NCT Number: NCT04089943

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases Vascular Diseases, Peripheral

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Austing Dell Medical School, Austin, Texas, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male or female 30 years or older,
  • Infrainguinal PAD,
  • critical limb ischemia, defined as arterial insufficiency with gangrene, nonhealing ischemic ulcer, or rest pain consistent,
  • candidate for both endovascular and open infra-inguinal revascularization as judged by the vascular surgeons,
  • absence of musculoskeletal (most commonly arthritis related) or neurologic (most commonly back pain and sciatica related) symptoms,
  • willingness to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent.

Exclusion criteria

  • life expectancy of less than 2 years due to reasons other than PAD,
  • acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma,
  • current chemotherapy or radiation therapy

Treatment and study plan

Revascularization operation

Procedure

Participants will be randomized into an endovascular or open bypass procedure.

Control Group

Other

Healthy non-PAD participants will be recruited for the study.

Primary outcomes

  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 outcomes

  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 (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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of West Florida

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

The Role of microRNA-210 in Regulating Oxidative Stress in Patients With Peripheral Artery Disease

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Sep 13, 2019
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.