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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Arterial Occlusive Diseases; Peripheral Arterial Disease; Atherosclerosis; Vascular Diseases, Peripheral
• Intervention / Treatment: Procedure: Revascularization operation; Other: Control group

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 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.

• Study Type: Interventional
• Enrollment (Anticipated): 230
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Panagiotis Koutakis, PhD; Phone Number: 254-710-2160; Email: panagiotis_koutakis@baylor.edu

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • University of Texas Health Science Center at San Antonio
      • Contact: Dimitrios Miserlis, MD
    • Temple, Texas, United States, 76508
      • Recruiting
      • Baylor Scott and White Hospital
      • Contact: William T Bohannon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Baylor University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Panagiotis Koutakis, PhD, Baylor University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 15, 2019
• Primary Completion (ANTICIPATED): March 29, 2024
• Study Completion (ANTICIPATED): March 31, 2024

Study Registration Dates

• First Submitted: September 10, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (ACTUAL): September 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: microRNA; peripheral artery disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: STUDY00000272; 1R01AG064420 (NIH)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No