Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia

NCT05111288 | Recruiting DMC FDA Device

• 1 other identifier: 19-008996
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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).

Conditions

Coronary Artery Disease; Myocardial Infarction

Keywords

Exercise induced ischemia

Outcome Measures

Primary Outcomes (1)

• Myocardial blood flow during chemical stress

  assessment of myocardial blood flow using 13N-ammonia myocardial perfusion positron emission tomography (PET) to quantify blood flow during chemical induced stress

  change from baseline to post 6 months treatment

Secondary Outcomes (5)

• Peak Oxygen Consumption

  change from baseline to post 6 months treatment

• Seattle Angina Questionnaire

  change from baseline to post 6 months treatment

• Time to angina onset during exercise

  change from baseline to post 6 months treatment

• Exercise capacity (treadmill time)

  change from baseline to post 6 months treatment

• New York Heart Association Heart Failure Functional classification

  change from baseline to post 6 months treatment

Study Arms (2)

Pulsed electromagnetic field (PEMF) therapy

EXPERIMENTAL

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.

Device: Pulsed electromagnetic field therapy (PEMF)

Sham PEMF therapy

SHAM COMPARATOR

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.

Device: Inactive Pulsed electromagnetic field therapy (PEMF)

Interventions

Pulsed electromagnetic field therapy (PEMF) 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.

Pulsed electromagnetic field (PEMF) therapy

Inactive Pulsed electromagnetic field therapy (PEMF) DEVICE

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

Sham PEMF therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Courtney Wheatley-Guy, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Bruce Johnson, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 8, 2021
• Study Start: May 18, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (2)