What side effects are associated with this type of intervention?

Common treatments for Coronary Artery Disease (CAD) include medications, lifestyle changes, and various therapies. For non-invasive treatments like cardiac shock wave therapy, side effects are generally minimal but can include mild discomfort or pain at the treatment site. Medications such as nitroglycerin patches can cause headaches, dizziness, and skin irritation at the application site. More invasive treatments like stent placement or bypass surgery carry risks of infection, bleeding, and adverse reactions to anesthesia. Overall, non-invasive therapies like pulsed electromagnetic waves are generally well-tolerated with fewer side effects compared to surgical interventions.

What prior FDA approvals exist?

The FDA has approved various treatments for Coronary Artery Disease (CAD), including drug-eluting stents (DES) and bare-metal stents (BMS), which help keep arteries open after procedures like angioplasty. Bioabsorbable polymer-based drug-eluting stents (BP-BES) have shown promise in reducing cardiac death and myocardial infarction rates. While pulsed electromagnetic wave therapy, like the Bioboosti device, is being studied for its potential to improve blood flow in CAD patients, it is not yet FDA-approved. Traditional treatments focus on mechanical and pharmacological methods to manage and improve blood flow and reduce the risk of adverse cardiac events.

What other types of research exist?

Promising alternatives to Bioboosti for CAD patients include: 1) Evolocumab, a PCSK9 inhibitor, which has shown efficacy in reducing acute arterial events across all vascular territories. 2) BioFreedom stent, a polymer-free biolimus-A9 coated stent, which is effective for patients with high bleeding risk and requires a shortened duration of dual antiplatelet therapy. 3) Endobarrier devices, which have shown potential in treating obesity and metabolic syndrome, indirectly benefiting CAD patients by improving metabolic health.

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Electromagnetic Therapy

PEMF Therapy for Coronary Artery Disease

N/A

Recruiting

Led By Courtney Wheatley-Guy, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Known cardiac ischemia, who are non revascularizable, or have not and will not be undergo coronary intervention for the duration of their participation in the study

Able to complete a cardiopulmonary exercise test without significant non cardiac limitations, primarily orthopedic

Must not have

Significant arrhythmia (ventricular tachycardia, ventricular fibrillation, frequent premature ventricular contractions (PVCs), persistent atrial fibrillation, or 2nd or 3rd degree atrioventricular (AV) block)

Recent myocardial infarction (< 90 days)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to post 6 months treatment

Summary

This trial is testing a device called Bioboosti that uses gentle electromagnetic waves to help improve blood flow. It targets people with coronary artery disease who have poor blood flow to their heart. The treatment works by helping blood vessels function better and aiding tissue repair.

Who is the study for?

This trial is for adults over 18 with stable heart ischemia who can't have or won't get coronary intervention. They must be on optimal therapy, able to exercise (except for severe orthopedic issues), and have a left ventricular ejection fraction over 40%. Excluded are those with recent heart procedures, seizures, unstable angina, certain blood conditions, severe kidney disease, extreme obesity, pregnancy or breastfeeding.

What is being tested?

The study tests the Bioboosti device's pulsed electromagnetic waves on improving blood flow in the heart of people with coronary artery disease. Participants will either receive active PEMF treatment or an inactive version to compare effects.

What are the potential side effects?

While not explicitly listed here, potential side effects may include discomfort at the site of application or skin irritation from the device. Since it's non-invasive and uses electromagnetic fields, systemic side effects are unlikely but could involve headaches or dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have heart issues that cannot or will not be treated with surgery during the study.

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I can do a heart-lung workout test without major issues, especially with my bones and joints.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have serious heart rhythm problems.

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I have not had a heart attack in the last 3 months.

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My BMI is over 42, indicating morbid obesity.

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I can't exercise mainly because of a bone or joint problem.

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I have severe lung disease.

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I have unstable chest pain.

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I have seizures.

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I have experienced sudden chest pain due to coronary spasm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to post 6 months treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to post 6 months treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to post 6 months treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Myocardial blood flow during chemical stress

Secondary study objectives

Exercise capacity (treadmill time)

New York Heart Association Heart Failure Functional classification

Peak Oxygen Consumption

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Pulsed electromagnetic field (PEMF) therapyExperimental Treatment1 Intervention

A portable PEMF device will be utilized. For the PEMF group, the device includes adjustable magnetic field strength range (X-axis: 0.22±0.05 mT, Y-axis: 0.20±0.05 mT and Z-axis: 0.06±0.02 mT) and working frequency (30±3Hz). This magnetic strength range and frequency will be maintained during 180 days of the study period. The subjects will be instructed to use their device three times per day: providing micromagnetic emitting on both hands (palms) during morning, afternoon and evening/night sessions. Each session takes 16 min (both hands, 8 min per hand) and thus subjects are exposed to therapy for 48 min per day. Subjects will use the device as outlined continuously up through the final days of testing.

Group II: Sham PEMF therapyPlacebo Group1 Intervention

The sham PEMF devices are modified to deliver no micromagnetic field when turned on. The subjects will be instructed to use their device three times per day: providing micromagnetic emitting on both hands (palms) during morning, afternoon and evening/night sessions. Each session takes 16 min (both hands, 8 min per hand) and thus subjects are exposed to therapy for 48 min per day. Subjects will use the device as outlined continuously up through the final days of testing.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Coronary Artery Disease (CAD) include lifestyle changes, medications, and medical procedures. Medications such as statins lower cholesterol, antiplatelet agents prevent blood clots, and beta-blockers reduce heart workload. Medical procedures like angioplasty and stent placement open narrowed arteries. Pulsed Electromagnetic Waves (PEMW), like those studied in the Bioboosti trial, aim to improve blood flow by enhancing microcirculation and reducing inflammation. This is crucial for CAD patients as improved blood flow can alleviate symptoms, reduce the risk of heart attacks, and enhance overall heart function.

[The use of low-intensity laser irradiation of the blood in myocardial infarction].A Role for Photobiomodulation in the Prevention of Myocardial Ischemic Reperfusion Injury: A Systematic Review and Potential Molecular Mechanisms.