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

  • STATUS
    Recruiting
  • End date
    Mar 31, 2024
  • participants needed
    230
  • sponsor
    Baylor University
Updated on 16 March 2022
arteriopathy
peripheral artery disease
ischemia
arterial disease
gangrene
limb ischemia
rest pain
critical limb ischemia
peripheral arterial diseases
critical limb ischaemia
ischemic ulcer
revascularisation
Accepts healthy volunteers

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.

Details
Condition Peripheral Arterial Disease, Vascular Diseases, Peripheral, Arterial Occlusive Diseases, Atherosclerosis
Treatment Control group, Revascularization operation
Clinical Study IdentifierNCT04089943
SponsorBaylor University
Last Modified on16 March 2022

Eligibility

Yes No Not Sure

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
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