Clinical trial NCT04089943: The Role of microRNA-210 in Regulating Oxidative Stress in Patients With PAD
Official title: The Role of microRNA-210 in Regulating Oxidative Stress in Patients With Peripheral Artery Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Vascular Diseases, Peripheral
Arterial Occlusive Diseases
Atherosclerosis
Keywords: peripheral artery disease
microRNA
Lead sponsor: University of West Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-09-13
Enrollment: 230
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: miR-210 gene expression
timeFrame: Change from baseline to six-month follow-up
measure: Calf muscle biopsy biochemical measures
timeFrame: Change from baseline to six-month follow-up
Secondary outcomes:
measure: Six-minute walk performance
timeFrame: Change from baseline to six-month follow-up
measure: Graded treadmill walk performance
timeFrame: Change from baseline to six-month follow-up
measure: The 36-Item Short Form questionnaire (SF-36)
timeFrame: Change from baseline to six-month follow-up
measure: The Walking Impairment Questionnaire
timeFrame: Change from baseline to six-month follow-up
Other outcomes:
Locations:
city: Austin
country: United States
facility: UT Austing Dell Medical School
state: Texas
city: Temple
country: United States
facility: Baylor Scott and White
state: Texas
Study officials:
affiliation: University of West Florida
name: Panagiotis Koutakis, PhD
role: PRINCIPAL_INVESTIGATOR
References: