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

University of West Florida

Status: Active, not recruiting

Conditions: Arterial Occlusive Diseases; Vascular Diseases, Peripheral; Peripheral Arterial Disease; Atherosclerosis

Treatments: Other: Control group; Procedure: Revascularization operation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04089943

2211301

1R01AG064420 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 230 patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

Revascularization group

Experimental group

Description:

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

Treatment:

Procedure: Revascularization operation

Control group

Other group

Description:

Healthy non-PAD participants will be recruited as control group

Treatment:

Other: Control group