Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia

Conditions
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Coronary Artery Disease, Myocardial Infarction

Intervention / Treatment
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* Device: Pulsed electromagnetic field therapy (PEMF)
* Device: Inactive Pulsed electromagnetic field therapy (PEMF)


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulsed electromagnetic field (PEMF) therapy<br>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)<br>* 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.<br>|
| Sham Comparator: Sham PEMF therapy<br>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)<br>* PEMF device that turns on but does not provide any electromagnetic stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise induced ischemia