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

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04089943
• Other study ID #: STUDY00000272
• Secondary ID: 1R01AG064420
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2019
• Est. completion date: March 31, 2024

Study information

• Verified date: February 2023
• Source: Baylor University
• Contact: Panagiotis Koutakis, PhD
• Phone: 254-710-2160
• Email: panagiotis_koutakis[@]baylor.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: March 31, 2024
• Est. primary completion date: March 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Revascularization operation
Participants will be randomized into an endovascular or open bypass procedure.

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

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Baylor Scott and White Hospital	Temple	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	miR-210 gene expression	Measure miR-210 gene expression at baseline and after intervention	Change from baseline to six-month follow-up
Primary	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	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
Secondary	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
Secondary	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
Secondary	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