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Electromagnetic Therapy

PEMF Therapy for Coronary Artery Disease

N/A
Recruiting
Led By Bruce Johnson, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
On guideline directed optimal therapy for stable ischemia
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to post 6 months treatment
Awards & highlights

Study Summary

This trial is to study a device that uses electrical waves to improve blood flow to the heart in people with coronary artery disease.

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.Check my eligibility
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.See study design
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 am following recommended treatment for stable heart-related chest pain.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Myocardial blood flow during chemical stress
Secondary outcome measures
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.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,191 Previous Clinical Trials
3,758,372 Total Patients Enrolled
Bruce Johnson, PhDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
67 Total Patients Enrolled

Media Library

Bioboosti (Electromagnetic Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05111288 — N/A
Heart Attack Clinical Trial 2023: Bioboosti Highlights & Side Effects. Trial Name: NCT05111288 — N/A
Bioboosti (Electromagnetic Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05111288 — N/A
Heart Attack Research Study Groups: Pulsed electromagnetic field (PEMF) therapy, Sham PEMF therapy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the expected enrollment size for this trial?

"That is correct. Clinicaltrials.gov states that the trial, initially posted on May 18th 2022 and last updated a week later, is actively seeking volunteers to join. 120 participants are expected to be recruited between two different sites."

Answered by AI

Are any new participants currently being accepted for this trial?

"Affirmative. Clinicaltrials.gov states that this medical experiment is actively searching for subjects, with the original post being made on May 18th 2022 and any recent edits occurring a week later on May 25th of the same year. To be successful, 120 people must sign up for participation at two separate sites."

Answered by AI
~29 spots leftby Nov 2024