MicroRNA-210 Regulation for Peripheral Arterial Disease

Recruiting at 3 trial locations

Overseen By Panagiotis Koutakis, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of West Florida

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-operative period

230 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment miR-210 for Peripheral Arterial Disease?

Research shows that microRNAs, like miR-210, play a role in important processes related to Peripheral Arterial Disease (PAD), such as blood vessel growth and repair, inflammation, and cell function. This suggests that targeting microRNAs could be a promising approach for treating PAD. ^{1 2 3 4 5}

Is MicroRNA-210 treatment safe for humans?

The available research on MicroRNA-210 (miR-210) primarily involves animal studies, which show it may help improve blood flow and reduce harmful molecules in conditions like peripheral artery disease. However, there is no direct safety data for humans, so its safety in people is not yet confirmed. ^{1 2 3 6 7}

How does the miR-210 treatment differ from other treatments for peripheral arterial disease?

The miR-210 treatment is unique because it enhances blood vessel growth and recovery in damaged tissues by reducing harmful reactive oxygen species, which is different from traditional treatments that may not target these specific molecular pathways. ^{3 6 7 8 9}

Research Team

Panagiotis Koutakis, PhD

Principal Investigator

University of West Florida

Eligibility Criteria

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.

Inclusion Criteria

Willingness to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent

I am 30 years old or older.

I have severe leg pain or non-healing wounds due to poor blood flow.

Exclusion Criteria

I recently had a blood clot or injury affecting my leg.

I am expected to live less than 2 years because of conditions not related to PAD.

I am currently undergoing chemotherapy or radiation therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either an endovascular or open bypass procedure as part of the revascularization treatment

Immediate post-operative period

1 visit (in-person for procedure)

Follow-up

Participants are monitored for changes in miR-210 expression, walking performance, and quality of life

6 months

Multiple visits (in-person and virtual)

Control Group Monitoring

Healthy non-PAD participants are monitored as a control group for comparison

6 months

Treatment Details

Interventions

• miR-210
• Revascularization operation

Trial Overview 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.

Participant Groups

Group I: Revascularization group Experimental Treatment 1 Intervention

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

Group II: Control group Experimental Treatment 1 Intervention

Healthy non-PAD participants will be recruited as control group

Who Is Running the Clinical Trial?

University of West Florida

Lead Sponsor

Trials

1

Recruited

230+

Baylor University

Lead Sponsor

Trials

65

Recruited

67,600+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

References

1. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Therapeutic Potential of Modulating MicroRNA in Peripheral Artery Disease. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Increased miR-142 Levels in Plasma and Atherosclerotic Plaques from Peripheral Artery Disease Patients with Post-Surgery Cardiovascular Events. [2021]

3. Greece pubmed.ncbi.nlm.nih.gov

Role of microRNAs in peripheral artery disease (review). [2013]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Relationships between Indicators of Lower Extremity Artery Disease and miRNA Expression in Peripheral Blood Mononuclear Cells. [2022]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

MicroRNAs in peripheral artery disease. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Hypoxia-induced miR-210 modulates tissue response to acute peripheral ischemia. [2021]

7. Greece pubmed.ncbi.nlm.nih.gov

MicroRNA-210 improves perfusion recovery following hindlimb ischemia via suppressing reactive oxygen species. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

MicroRNA expression signature and antisense-mediated depletion reveal an essential role of MicroRNA in vascular neointimal lesion formation. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Hypoxia-Induced miR-210 Is Necessary for Vascular Regeneration upon Acute Limb Ischemia. [2020]