Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease; Myocardial Infarction
• Interventions: Device: Pulsed electromagnetic field therapy (PEMF); Device: Inactive Pulsed electromagnetic field therapy (PEMF)

• Registration Number: NCT05111288
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2021-10-27
• Study First Submitted QC: 2021-10-27
• Study First Posted: 2021-11-08
• Study Start: 2022-05-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulsed electromagnetic field (PEMF) therapy	Pulsed electromagnetic field therapy (PEMF)	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.
Sham PEMF therapy	Inactive Pulsed electromagnetic field therapy (PEMF)	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.

Primary Outcome Measures

Name	Time	Method
Myocardial blood flow during chemical stress	change from baseline to post 6 months treatment	assessment of myocardial blood flow using 13N-ammonia myocardial perfusion positron emission tomography (PET) to quantify blood flow during chemical induced stress

Secondary Outcome Measures

Name	Time	Method
Peak Oxygen Consumption	change from baseline to post 6 months treatment	Maximal oxygen consumption during maximal oxygen consumption
Seattle Angina Questionnaire	change from baseline to post 6 months treatment	questionnaire to assess angina symptoms where scores range from 0- 100 and higher scores mean better outcomes or less angina symptoms
Time to angina onset during exercise	change from baseline to post 6 months treatment	angina onset/threshold intensity during maximal exercise test
Exercise capacity (treadmill time)	change from baseline to post 6 months treatment	total time on treadmill with maximal exercise test
New York Heart Association Heart Failure Functional classification	change from baseline to post 6 months treatment	New York Heart Association classification on functional ability of heart failure patients based on symptoms

Trial Locations

Locations (2)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States