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

Primary Purpose

Peripheral Arterial Disease, Vascular Diseases, Peripheral, Arterial Occlusive Diseases

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Revascularization operation

Control group

About this trial

This is an interventional basic science trial for Peripheral Arterial Disease focused on measuring peripheral artery disease, microRNA

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Texas Health Science Center at San AntonioRecruiting
Baylor Scott and White HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Revascularization group

Control group

Arm Description

Participants will be randomized to either an endovascular or an open bypass procedure.

Healthy non-PAD participants will be recruited as control group

Outcomes

Primary Outcome Measures

miR-210 gene expression

Measure miR-210 gene expression at baseline and after intervention

Calf muscle biopsy biochemical measures

A skeletal muscle sample will be obtained from the gastrocnemius muscle.

Secondary Outcome Measures

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

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.

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.

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.

Full Information

NCT ID

NCT04089943

First Posted

September 10, 2019

Last Updated

February 3, 2023

Sponsor

Baylor University

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT04089943

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 15, 2019 (Actual)

Primary Completion Date

March 29, 2024 (Anticipated)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Baylor University

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

peripheral artery disease, microRNA

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Revascularization group

Arm Type

Experimental

Arm Description

Participants will be randomized to either an endovascular or an open bypass procedure.

Arm Title

Control group

Arm Type

Other

Arm Description

Healthy non-PAD participants will be recruited as control group

Intervention Type

Procedure

Intervention Name(s)

Revascularization operation

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Control group

Intervention Description

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

Primary Outcome Measure Information:

Title

miR-210 gene expression

Description

Measure miR-210 gene expression at baseline and after intervention

Time Frame

Change from baseline to six-month follow-up

Title

Calf muscle biopsy biochemical measures

Description

A skeletal muscle sample will be obtained from the gastrocnemius muscle.

Time Frame

Change from baseline to six-month follow-up

Secondary Outcome Measure Information:

Title

Six-minute walk performance

Description

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

Time Frame

Change from baseline to six-month follow-up

Title

Graded treadmill walk performance

Description

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.

Time Frame

Change from baseline to six-month follow-up

Title

The 36-Item Short Form questionnaire (SF-36)

Description

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.

Time Frame

Change from baseline to six-month follow-up

Title

The Walking Impairment Questionnaire

Description

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.

Time Frame

Change from baseline to six-month follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Panagiotis Koutakis, PhD

Phone

254-710-2160

panagiotis_koutakis@baylor.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Panagiotis Koutakis, PhD

Organizational Affiliation

Baylor University

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Health Science Center at San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dimitrios Miserlis, MD

Facility Name

Baylor Scott and White Hospital

City

Temple

State/Province

Texas

ZIP/Postal Code

76508

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

William T Bohannon, MD

12. IPD Sharing Statement

Learn more about this trial

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

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