Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia

NCT ID: NCT05111288

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-18
• Study Completion Date: 2026-08-31

Brief Summary

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 to improve blood flow to the heart tissue in individuals with coronary artery disease (CAD).

Detailed Description

Pulsed electromagnetic field (PEMF) therapy is a noninvasive technique, which provides low field electromagnetic stimulation. The therapy of PEMF is achieved by altering biological and physiological systems via low energy and non-ionizing electromagnetic fields. PEMF therapy was originally used clinically to manage osteoarthritis related pain and stiffness and to augment bone healing. In addition, recent research has explored the beneficial therapeutic effect of PEMF on microvasculature and circulation. More recently, research interest has been toward the effect of PEMF on various targets, including peripheral vascular function and blood flow. It has been suggested that PEMF therapy enhances the binding of free calcium (Ca2+) to calmodulin (CaM) and this phenomenon might improve tissue repair and pain and moreover other studies suggested an effect of PEMF on Ca/CaM-dependent nitric oxide (NO) signaling pathway, which is one of the major components for controlling vascular tone and blood pressure (BP, figure 1). The investigators have recently demonstrated that in subjects with metabolic syndrome with hypertension, 12 weeks of daily therapy using Bioboosti tended to lower BP and raise plasma NO levels as well as improve flow mediated dilation. In a small pilot study from China, subjects with a history of diffuse coronary disease and evidence of myocardial ischemia performed radionuclide SPECT before and after PEMF therapy or control. In this small pilot study there was evidence of reduced ischemia in the treatment group vs a control group. Thus the focus of this proposal is to pursue a larger clinical trial to demonstrate the benefits of PEMF therapy using the Bioboosti PEMF device to reduce the ischemic burden in patients with coronary artery disease.

Conditions

Coronary Artery Disease; Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Pulsed electromagnetic field (PEMF) therapy

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 Type: EXPERIMENTAL

Pulsed electromagnetic field therapy (PEMF)

Intervention Type: DEVICE

Pulsed electromagnetic field (PEMF) therapy is a noninvasive technique, which provides low field electromagnetic stimulation. The therapy of PEMF is achieved by altering biological and physiological systems via low energy and non-ionizing electromagnetic fields.

Sham PEMF therapy

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.

Group Type: SHAM_COMPARATOR

Inactive Pulsed electromagnetic field therapy (PEMF)

Intervention Type: DEVICE

PEMF device that turns on but does not provide any electromagnetic stimulation

Interventions

Pulsed electromagnetic field therapy (PEMF)

Pulsed electromagnetic field (PEMF) therapy is a noninvasive technique, which provides low field electromagnetic stimulation. The therapy of PEMF is achieved by altering biological and physiological systems via low energy and non-ionizing electromagnetic fields.

Intervention Type: DEVICE

Inactive Pulsed electromagnetic field therapy (PEMF)

PEMF device that turns on but does not provide any electromagnetic stimulation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years old.
• 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.
• Evidence of ischemia from previous clinical tests (echo, nuclear, standard ECG from past 6 months).
• Left Ventricular Ejection fraction > 40% by echo (evaluated last 3 months).
• Able to complete a cardiopulmonary exercise test without significant non cardiac limitations, primarily orthopedic.
• On guideline directed optimal therapy for stable ischemia.

Exclusion Criteria

• Anemia (< 7 mg/dl).
• Low potassium (< 3 mmol/L).
• Creatinine (> 5.0 mg/dl or < 0.6 mg/dl).
• Unable to exercise due primarily to orthopedic limitation.
• Severe lung disease.
• Morbid obesity (BMI > 42).
• Pregnant.
• Breast feeding.
• Significant arrhythmia (ventricular tachycardia, ventricular fibrillation, frequent premature ventricular contractions (PVCs), persistent atrial fibrillation, or 2nd or 3rd degree atrioventricular (AV) block).
• Seizures.
• Unstable angina.
• Coronary spasm.
• Recent myocardial infarction (< 90 days).
• Recent percutaneous coronary intervention (<90 days).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Courtney M. Wheatley

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Courtney Wheatley-Guy, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Bruce Johnson, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status: RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Jordan Parks

Role: primary

parks.jordan@mayo.edu

480-301-6616

Denise White

Role: backup

white.denise@mayo.edu

480-342-6741

Sarah Devamani

Role: primary

devamani.sarah@mayo.edu

507-255-0876

Briana Ziegler

Role: backup

zeigler.briana@mayo.edu

507-255-7125

Other Identifiers

19-008996

Identifier Type: -

Identifier Source: org_study_id