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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 belowSelect...
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:Select...
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
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 moreTrial 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.
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.
[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.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,355 Previous Clinical Trials
3,061,593 Total Patients Enrolled
Courtney Wheatley-Guy, PhDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
60 Total Patients Enrolled
Bruce Johnson, PhDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
34 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently breastfeeding.I am following recommended treatment for stable heart-related chest pain.I have not had a heart attack in the last 3 months.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.You have severe anemia with hemoglobin levels below 7 grams per deciliter.I have heart issues that cannot or will not be treated with surgery during the study.I can do a heart-lung workout test without major issues, especially with my bones and joints.I do not have serious heart rhythm problems.Your blood potassium level is less than 3 mmol/L.My BMI is over 42, indicating morbid obesity.I can't exercise mainly because of a bone or joint problem.I have severe lung disease.Your creatinine levels are too high or too low.I had a heart stent placed less than 3 months ago.I have unstable chest pain.I have seizures.I am 18 years old or older.I have experienced sudden chest pain due to coronary spasm.
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Pulsed electromagnetic field (PEMF) therapy
- Group 2: Sham PEMF therapy