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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04089943
Other study ID # STUDY00000272
Secondary ID 1R01AG064420
Status Recruiting
Phase N/A
First received
Last updated
Start date September 15, 2019
Est. completion date March 31, 2024

Study information

Verified date February 2023
Source Baylor University
Contact Panagiotis Koutakis, PhD
Phone 254-710-2160
Email panagiotis_koutakis@baylor.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 230
Est. completion date March 31, 2024
Est. primary completion date March 29, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years and older
Eligibility 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

Study Design


Intervention

Procedure:
Revascularization operation
Participants will be randomized into an endovascular or open bypass procedure.
Other:
Control group
Healthy non-PAD participants will be recruited for the study.

Locations

Country Name City State
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Baylor Scott and White Hospital Temple Texas

Sponsors (2)

Lead Sponsor Collaborator
Baylor University National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary miR-210 gene expression Measure miR-210 gene expression at baseline and after intervention Change from baseline to six-month follow-up
Primary Calf muscle biopsy biochemical measures A skeletal muscle sample will be obtained from the gastrocnemius muscle. Change from baseline to six-month follow-up
Secondary Six-minute walk performance Participants walking up and down a 100 foot hallway for six minutes following a standardized protocol. The goal is for them to walk as far as possible in six minutes Change from baseline to six-month follow-up
Secondary Graded treadmill walk performance Participants walking on treadmill following a standardized protocol. The goal is for them to walk as far as possible while the treadmill incline increases every 2 minutes. Change from baseline to six-month follow-up
Secondary The 36-Item Short Form questionnaire (SF-36) This well validated quality of life measure will be used to assess changes in patient perceived quality of life. The SF-36 is scored from 0-100, with 100 being the best score. Change from baseline to six-month follow-up
Secondary The Walking Impairment Questionnaire The well validated Walking Impairment Questionnaire (WIQ) will be used to measure patient- perceived walking performance. The WIQ is scored from 0-100, with 100 being the best score. Change from baseline to six-month follow-up
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