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

Sponsor

Baylor University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04089943

Collaborator

National Institute on Aging (NIA) (NIH)

230

Enrollment

Locations

Arms

54.5

Anticipated Duration (Months)

115

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease Vascular Diseases, Peripheral Arterial Occlusive Diseases Atherosclerosis	Procedure: Revascularization operation Other: Control group	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

230 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

The Role of microRNA-210 in Regulating Oxidative Stress in Patients With Peripheral Artery Disease

Actual Study Start Date :

Sep 15, 2019

Anticipated Primary Completion Date :

Mar 29, 2024

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Revascularization group Participants will be randomized to either an endovascular or an open bypass procedure.	Procedure: Revascularization operation Participants will be randomized into an endovascular or open bypass procedure.
Other: Control group Healthy non-PAD participants will be recruited as control group	Other: Control group Healthy non-PAD participants will be recruited for the study.

Arm

Intervention/Treatment

Experimental: Revascularization group

Participants will be randomized to either an endovascular or an open bypass procedure.

Procedure: Revascularization operation

Participants will be randomized into an endovascular or open bypass procedure.

Other: Control group

Healthy non-PAD participants will be recruited as control group

Other: Control group

Healthy non-PAD participants will be recruited for the study.

Outcome Measures

Primary Outcome Measures

miR-210 gene expression [Change from baseline to six-month follow-up]
Measure miR-210 gene expression at baseline and after intervention
Calf muscle biopsy biochemical measures [Change from baseline to six-month follow-up]
A skeletal muscle sample will be obtained from the gastrocnemius muscle.

Secondary Outcome Measures

Six-minute walk performance [Change from baseline to six-month follow-up]
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
Graded treadmill walk performance [Change from baseline to six-month follow-up]
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.
The 36-Item Short Form questionnaire (SF-36) [Change from baseline to six-month follow-up]
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.
The Walking Impairment Questionnaire [Change from baseline to six-month follow-up]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229
2	Baylor Scott and White Hospital	Temple	Texas	United States	76508