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microRNA

MicroRNA-210 Regulation for Peripheral Arterial Disease

N/A
Waitlist Available
Led By Panagiotis Koutakis, PhD
Research Sponsored by Baylor University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female 30 years or older
Presence of critical limb ischemia, defined as arterial insufficiency with gangrene, nonhealing ischemic ulcer, or rest pain consistent
Must not have
Acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma
Life expectancy of less than 2 years due to reasons other than PAD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to six-month follow-up
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at the role of microRNA-210 in peripheral artery disease and potential treatments.

Who is the study for?
This trial is for men and women over 30 with peripheral artery disease (PAD) who have severe limb pain or wounds due to poor blood flow, and are candidates for a revascularization operation. They must not have musculoskeletal or neurological symptoms that could affect the study, be willing to follow the study plan, attend check-ups, complete assessments, and give written consent. People undergoing chemotherapy or radiation therapy, those with a life expectancy under 2 years from non-PAD causes, or recent acute lower limb ischemic events can't participate.
What is being tested?
The trial is studying how microRNA-210 affects oxidative stress in PAD patients. It's looking at whether targeting miR-210 can improve mitochondrial function and quality of life by comparing two groups: one receiving standard care and another undergoing a revascularization operation designed to restore proper blood flow in affected limbs.
What are the potential side effects?
While specific side effects related to targeting miR-210 aren't detailed here, typical risks associated with revascularization operations include infection risk at the surgery site, bleeding complications, potential reactions to anesthesia during surgery, as well as general postoperative discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 30 years old or older.
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I have severe leg pain or non-healing wounds due to poor blood flow.
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I have been diagnosed with blockages in the arteries below my groin.
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I do not have arthritis, back pain, or sciatica.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I recently had a blood clot or injury affecting my leg.
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I am expected to live less than 2 years because of conditions not related to PAD.
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I am currently undergoing chemotherapy or radiation therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to six-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to six-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Calf muscle biopsy biochemical measures
miR-210 gene expression
Secondary study objectives
Graded treadmill walk performance
Six-minute walk performance
The 36-Item Short Form questionnaire (SF-36)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Revascularization groupExperimental Treatment1 Intervention
Participants will be randomized to either an endovascular or an open bypass procedure.
Group II: Control groupExperimental Treatment1 Intervention
Healthy non-PAD participants will be recruited as control group

Find a Location

Who is running the clinical trial?

Baylor UniversityLead Sponsor
62 Previous Clinical Trials
65,830 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,805 Previous Clinical Trials
28,194,627 Total Patients Enrolled
16 Trials studying Atherosclerosis
31,051 Patients Enrolled for Atherosclerosis
Panagiotis Koutakis, PhDPrincipal Investigator - University of West Florida
Baylor University

Media Library

miR-210 (microRNA) Clinical Trial Eligibility Overview. Trial Name: NCT04089943 — N/A
Atherosclerosis Research Study Groups: Revascularization group, Control group
Atherosclerosis Clinical Trial 2023: miR-210 Highlights & Side Effects. Trial Name: NCT04089943 — N/A
miR-210 (microRNA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04089943 — N/A
~37 spots leftby Dec 2025
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