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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-15

Study Completion Date

2025-08-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peripheral Arterial Disease Vascular Diseases, Peripheral Arterial Occlusive Diseases Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Revascularization group

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

Group Type EXPERIMENTAL

Revascularization operation

Intervention Type PROCEDURE

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

Control group

Healthy non-PAD participants will be recruited as control group

Group Type OTHER

Control group

Intervention Type OTHER

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

Interventions

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Revascularization operation

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

Intervention Type PROCEDURE

Control group

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes