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

Study Status: Active Not Recruiting

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.

  • Sex: ALL
  • Minimum Age: 30 Years
  • Healthy Volunteers: Yes

Researchers look for people who fit a certain description, called eligibility criteria. Below are the inclusion and exclusion criteria for study participants:

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.

Exlusion 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

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

Intervention/Treatment

Intervention/Treatment

  • PROCEDURE : Revascularization operation
  • OTHER : Control group

Sponsor

University of West Florida

Principal Investigator(s)

  • Panagiotis Koutakis, PhD, PRINCIPAL_INVESTIGATOR, University of West Florida

Phase

  • NA