MicroRNA-210 Regulation for Peripheral Arterial Disease

Not currently recruiting at 3 trial locations

Overseen By Panagiotis Koutakis, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of West Florida

Disqualifiers: Life expectancy, Chemotherapy, Radiation, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach using microRNA-210, a small molecule that may help treat peripheral artery disease (PAD). PAD reduces blood flow to the legs, causing pain and difficulty walking. The research examines how microRNA-210 affects oxidative stress (a type of cell damage) and aims to improve walking distance and quality of life for those with PAD. Participants will either undergo one of two revascularization procedures (operations to restore blood flow) or be part of a healthy control group. This trial suits individuals over 30 with PAD who experience severe leg pain or ulcers and can undergo specific surgeries. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could lead to new treatments for PAD.

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 prior data suggests that this protocol is safe for patients with peripheral artery disease?

Research has shown that miR-210 is under investigation for its potential role in treating peripheral artery disease (PAD). Studies have found that individuals with PAD exhibit higher levels of miR-210, suggesting its involvement in the disease. In lab tests, miR-210 improved blood flow after an injury, indicating it might aid in repairing blood vessels.

However, specific information about the safety of miR-210 in humans is not yet available. The trial's "Not Applicable" phase label likely indicates that researchers are still in the early stages of exploration. Participants should be aware that while miR-210 shows promise, its safety in humans remains under study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Peripheral Arterial Disease (PAD), such as medications, lifestyle changes, and surgical interventions, focus primarily on improving blood flow. However, miR-210 offers a novel approach by targeting microRNA pathways, which are crucial in regulating blood vessel formation and function. Researchers are excited about miR-210 because it could potentially enhance the body's natural ability to repair and grow new blood vessels, offering a promising alternative or complement to current treatments. This innovative mechanism of action could lead to more effective management of PAD with potentially fewer side effects.

What evidence suggests that this trial's treatments could be effective for peripheral artery disease?

Research has shown that people with peripheral artery disease (PAD) have higher levels of a molecule called microRNA-210 (miR-210), suggesting its involvement in the disease. Studies have found that miR-210 is linked to oxidative stress, which can damage cells and plays a significant role in PAD. MiR-210 may help regulate this stress, potentially improving symptoms such as walking distance and overall quality of life. Although more research is needed, early evidence suggests that miR-210 could be a promising target for treating PAD. Participants in this trial will join either the revascularization group, undergoing an endovascular or open bypass procedure, or the control group, consisting of healthy non-PAD participants. ^{1 3 6 7 8}

Who Is on the Research Team?

Panagiotis Koutakis, PhD

Principal Investigator

University of West Florida

Are You a Good Fit for This Trial?

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 currently undergoing chemotherapy or radiation therapy.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9197925/

Skeletal Muscle MiR-210 Expression is Associated with ... Previous studies have demonstrated that circulating microRNA (miR)-210 levels are elevated in peripheral artery disease (PAD) patients.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04089943

Study Details | NCT04089943 | The Role of microRNA-210 ... 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 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0344033822004885

A review on the role of miR-210 in human disorders miR-210 has been shown to be up-regulated in almost all types of examined cancer types, except for bladder cancer, angiosarcoma and glioblastoma.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04089943/the-role-of-microrna-210-in-regulating-oxidative-stress-in-patients-with-pad

The Role of microRNA-210 in Regulating Oxidative Stress ... Study Summary. MicroRNA-210 (miR-210) can be a potential therapeutic target of patients with peripheral artery disease (PAD).

5. translationalres.com translationalres.com/article/S1931-5244(22)00046-9/pdf

Skeletal muscle MiR-210 expression is associated with ... Previous studies have demonstrated that circulating microRNA (miR)-210 levels are ele- vated in peripheral artery disease (PAD) patients. MiR-210 is known ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35288364/

Skeletal muscle MiR-210 expression is associated ... - PubMed Previous studies have demonstrated that circulating microRNA (miR)-210 levels are elevated in peripheral artery disease (PAD) patients.

7. mdpi.com mdpi.com/1422-0067/21/1/129

Hypoxia-Induced miR-210 Is Necessary for Vascular ... We tested miR-210 ability to stimulate vascular regeneration following ischemia. We found that miR-210 was necessary and sufficient to stimulate blood perfusion ...

8. cellnatsci.com cellnatsci.com/2958-695X/article/10-61474-ncs-2024-00001

Revolutionizing Vascular Health: Unveiling the Potential of ... Several recent studies have demonstrated that miRNAs play a critical role in the development of atherosclerosis, encompassing conditions such as coronary artery ...