The Role of microRNA-210 in Regulating Oxidative Stress in Patients With PAD
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
- 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.
Exlusion 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
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Peripheral Arterial Disease, Vascular Diseases, Peripheral, Arterial Occlusive Diseases, AtherosclerosisIntervention/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