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microRNA

MicroRNA-210 Regulation for Peripheral Arterial Disease

N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to six-month follow-up
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 am considered a candidate for leg artery surgery by my vascular surgeon.
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I do not have arthritis, back pain, or sciatica.

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

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

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
53 Previous Clinical Trials
64,852 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,660 Previous Clinical Trials
28,004,629 Total Patients Enrolled
20 Trials studying Peripheral Arterial Disease
16,365 Patients Enrolled for Peripheral Arterial Disease
Panagiotis Koutakis, PhDPrincipal Investigator - Baylor University
Baylor University

Media Library

miR-210 (microRNA) Clinical Trial Eligibility Overview. Trial Name: NCT04089943 — N/A
Peripheral Arterial Disease Research Study Groups: Revascularization group, Control group
Peripheral Arterial Disease 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the estimated participation rate in this clinical trial?

"Affirmative, the information located on clinicaltrials.gov attests that this research endeavour is presently recruiting individuals to participate. This trial was introduced on September 15th 2019 and was recently updated in March 3rd 2022; it seeks 230 participants from two medical sites."

Answered by AI

What are the essential goals of this experiment?

"This medical trial's primary outcome measure is the Change from baseline to six-month follow-up of Calf muscle biopsy biochemical measures. Secondary assessments include Graded treadmill walk performance (where patients must strive for a maximum distance while on an inclining treadmill), Walking Impairment Questionnaire (scoring 0 - 100, with higher scores being ideal) and 36 Item Short Form questionnaire (again scoring between 0 - 100)."

Answered by AI

Are there any open enrollment opportunities for this clinical trial?

"Affirmative. Clinicaltrials.gov verifies that this clinical experiment, which was initially listed on September 15th 2019, is still actively recruiting participants. A total of 230 people need to be enrolled from 2 medical facilities."

Answered by AI
~42 spots leftby Mar 2025