PEMF Therapy for Coronary Artery Disease

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Optimal therapy

Disqualifiers: Severe lung disease, morbid obesity, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a device called Bioboosti can improve blood flow to the heart in individuals with coronary artery disease (CAD), a condition where blood vessels to the heart narrow. The study uses pulsed electromagnetic fields (PEMF) to determine their potential to enhance heart health. Participants will use either the active device or a sham (inactive) device three times a day. This trial may suit those with stable CAD who are not undergoing heart surgeries and can comfortably exercise despite their condition. As an unphased trial, it offers a unique opportunity to explore innovative treatment options for CAD.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should be on guideline-directed optimal therapy for stable ischemia, which suggests you may need to continue your current treatment.

What prior data suggests that the Bioboosti device is safe for individuals with coronary artery disease?

Research has shown that pulsed electromagnetic field (PEMF) therapy, as used in the Bioboosti device, is usually well-tolerated. Studies have found that PEMF can improve heart function and support healing after heart attacks in animals. Although detailed information on side effects is limited, PEMF has been safely used for other conditions, such as aiding bone healing in people. This suggests it might also be safe for heart disease. However, since this treatment remains under investigation, discussing any concerns with a doctor before joining a trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PEMF therapy for coronary artery disease because it offers a non-invasive approach using pulsed electromagnetic fields to potentially improve heart health. Unlike standard treatments like medication or surgical interventions, PEMF therapy is delivered through a portable device that emits micromagnetic fields to the palms, making it convenient and easy to use at home. This technique might offer a new way to manage symptoms by targeting cellular healing and blood flow, which could complement or even reduce the need for more invasive procedures.

What evidence suggests that the Bioboosti device is effective for coronary artery disease?

Research has shown that pulsed electromagnetic field (PEMF) therapy might benefit individuals with coronary artery disease (CAD). Studies indicate that PEMF therapy can enhance blood flow and support better heart function. One study demonstrated that PEMF therapy significantly improved heart health by reducing damage to heart cells and boosting heart performance. Another study found that PEMF therapy improved blood vessel function and lowered blood pressure in individuals with hypertension. In this trial, participants will receive either PEMF therapy or a sham PEMF therapy to assess its effectiveness in improving heart health in those with CAD. ^{1 3 4 5 6}

Who Is on the Research Team?

Bruce Johnson, PhD

Principal Investigator

Mayo Clinic

Courtney Wheatley-Guy, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am following recommended treatment for stable heart-related chest pain.

There is proof from recent tests that you have had problems with blood flow to your heart.

Your heart's pumping ability is good, and it was checked within the last 3 months.

Exclusion Criteria

You are currently breastfeeding.

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

You have severe anemia with hemoglobin levels below 7 grams per deciliter.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Bioboosti PEMF device three times per day for 180 days

26 weeks

Continuous daily use

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bioboosti

Trial Overview 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.

How Is the Trial Designed?

Group I: Pulsed electromagnetic field (PEMF) therapy Experimental Treatment 1 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 therapy Placebo Group 1 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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Pulsed Electromagnetic Field (PEMF) therapy has shown positive effects in preclinical studies on knee articular diseases, including promoting cell proliferation and reducing inflammation, making it a promising treatment option.

PEMF therapy is considered a valid conservative management strategy for conditions like early osteoarthritis and can also aid recovery after knee surgeries, such as arthroscopy or total knee arthroplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biophysical stimulation of the knee with PEMFs: from bench to bedside. Vicenti, G., Bizzoca, D., Nappi, VS., et al.[2019]

PEMFs (pulsed electromagnetic fields) have been shown to effectively promote bone healing in patients with nonunions, often preventing the need for amputation, and have been validated through several double-blind studies.

Recent research indicates that PEMFs can also have therapeutic effects on various clinical disorders, offering a non-invasive alternative to surgical treatments with lower risks and costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fundamental and practical aspects of therapeutic uses of pulsed electromagnetic fields (PEMFs). Bassett, CA.[2008]

Pulsed electromagnetic fields (PEMFs) can significantly upregulate adenosine receptors (A2A and A3ARs) in various cells, leading to a reduction in proinflammatory cytokines, which suggests a potential anti-inflammatory effect.

PEMFs may enhance cell proliferation and tissue matrix production in joint cells, and they could protect implanted constructs from inflammation and hypoxia damage, indicating their therapeutic potential in tissue engineering and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adenosine Receptors as a Biological Pathway for the Anti-Inflammatory and Beneficial Effects of Low Frequency Low Energy Pulsed Electromagnetic Fields. Varani, K., Vincenzi, F., Ravani, A., et al.[2018]

BEMER therapy, which uses low-frequency pulsed electromagnetic fields, was tested on 14 male cross-country runners during preseason training, showing potential benefits in improving ventilatory threshold (VT) despite no significant changes in overall aerobic capacity (VO2Peak).

The study suggests that using PEMF therapy before and after training sessions may help enhance performance metrics like VT, indicating its possible role in optimizing recovery and training outcomes for endurance athletes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Acute Low-Frequency Pulsed Electromagnetic Field Therapy on Aerobic Performance during a Preseason Training Camp: A Pilot Study. Tamulevicius, N., Wadhi, T., Oviedo, GR., et al.[2021]

Pulsed electromagnetic field (PEMF) therapy significantly reduced muscle soreness and improved recovery metrics like median frequency and electromechanical delay in 30 healthy male college students after inducing delayed onset muscle soreness (DOMS).

While PEMF therapy showed benefits in alleviating DOMS symptoms, it did not enhance peak torque generation compared to a sham treatment, indicating that its primary effect may be on recovery rather than strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of pulsed electromagnetic field therapy on delayed-onset muscle soreness in biceps brachii. Jeon, HS., Kang, SY., Park, JH., et al.[2019]

Pulsed electromagnetic field (PEMF) exposure significantly enhances the proliferation of human adipose-derived stem cells (hASCs) and promotes their osteogenic differentiation, particularly at a specific intensity of 1 mT and frequency of 50 Hz.

After two weeks of PEMF treatment, there was an increase in bone-related gene expression, and after three weeks, proteins associated with bone formation, such as OPN, OCN, and RUNX-2, were also elevated, indicating a strong potential for PEMF in bone regeneration therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of a Pulsed Electromagnetic Field on the Proliferation and Osteogenic Differentiation of Human Adipose-Derived Stem Cells. Yin, Y., Chen, P., Yu, Q., et al.[2018]

Photobiomodulation therapy (PBMT) applied 30 minutes or 6 hours before cycling did not improve time to exhaustion or affect blood flow velocity and plasma nitrite levels in healthy untrained men, based on a study involving 13 participants.

The study found no significant changes in cardiorespiratory responses, blood acid-base balance, or lactate and potassium concentrations during exercise, indicating that PBMT at the tested dose may not enhance exercise performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation 30 min or 6 h Prior to Cycling Does Not Alter Resting Blood Flow Velocity, Exercise-Induced Physiological Responses or Time to Exhaustion in Healthy Men. Dutra, YM., Claus, GM., Malta, ES., et al.[2022]

Photobiomodulation therapy (PBMT) significantly enhances muscle endurance in single-joint exercises and improves time to exhaustion in cycling, based on a meta-analysis of 37 studies involving 586 participants.

However, PBMT does not show effectiveness in improving muscle strength in single-joint exercises or performance metrics in running and swimming, indicating its benefits are specific to certain types of exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deconstructing the Ergogenic Effects of Photobiomodulation: A Systematic Review and Meta-analysis of its Efficacy in Improving Mode-Specific Exercise Performance in Humans. Dutra, YM., Malta, ES., Elias, AS., et al.[2023]

Photobiomodulation therapy (PBMT) significantly improved muscle performance in the shoulder external-rotator muscles during high-intensity resistance exercise, with performance measures showing a 6.2% to 10% increase compared to a sham treatment.

The study involved 20 healthy participants and demonstrated that PBMT is a safe and noninvasive method to reduce fatigue and enhance muscular function, potentially lowering the risk of injury during strenuous workouts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Photobiomodulation Before Strenuous Exercise Attenuates Shoulder Muscle Fatigue. Crow, JA., Stauffer, JW., Levine, D., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05111288

Influence of Pulse Electromagnetic Field Therapy on ... This study is being done to observe the effects of treatment from a device called the Bioboosti which utilizes pulsed electromagnetic waves on its ability ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8030044/

Impact of pulsed electromagnetic field therapy on vascular ... This study supports the hypothesis that 12 weeks of PEMF therapy can improve endothelial vascular function and blood pressure in hypertensive individuals.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4058309/

Pulsed electromagnetic field improves cardiac function in ... The data demonstrated that PEMF treatment significantly inhibited cardiac apoptosis and improved cardiac systolic function. Moreover, PEMF treatment ...

4. withpower.com withpower.com/trial/phase-ischemia-10-2021-c7245

PEMF Therapy for Coronary Artery Disease PEMFs (pulsed electromagnetic fields) have been shown to effectively promote bone healing in patients with nonunions, often preventing the need for amputation, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2090123225002632

Pulsed electromagnetic fields treatment ameliorates ... In post-MI mice, PEMF treatment enhanced cardiac function and reduced scar formation. PEMF reduced the macrophage inflammatory response, ...

6. mayo.edu mayo.edu/research/clinical-trials/cls-20491778

A Study to Evaluate the Influence of Pulse Electromagnetic ... The purpose of this study is to determine the impact of pulse electromagnetic field (PEMF) therapy using the Bioboosti device (Biomobie Regenerative Medicine ...