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

Not Applicable

Active, not recruiting

• Conditions: Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Vascular Diseases, Peripheral
• Interventions: Procedure: Revascularization operation; Other: Control group

• Registration Number: NCT04089943
• Lead Sponsor: University of West Florida

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.

Study Timeline

• Study First Submitted: 2019-09-10
• Study First Submitted QC: 2019-09-12
• Study First Posted: 2019-09-13
• Study Start: 2019-09-15
• Primary Completion: 2024-08-29
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Study Completion: 2025-08-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 230

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Revascularization group	Revascularization operation	Participants will be randomized to either an endovascular or an open bypass procedure.
Control group	Control group	Healthy non-PAD participants will be recruited as control group

Primary Outcome Measures

Name	Time	Method
miR-210 gene expression	Change from baseline to six-month follow-up	Measure miR-210 gene expression at baseline and after intervention
Calf muscle biopsy biochemical measures	Change from baseline to six-month follow-up	A skeletal muscle sample will be obtained from the gastrocnemius muscle.

Secondary Outcome Measures

Name	Time	Method
Six-minute walk performance	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
Graded treadmill walk performance	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.
The 36-Item Short Form questionnaire (SF-36)	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.
The Walking Impairment Questionnaire	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.

Trial Locations

Locations (2)

UT Austing Dell Medical School; 🇺🇸 Austin, Texas, United States

Baylor Scott and White; 🇺🇸 Temple, Texas, United States