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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
120
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 device that turns on but does not provide any electromagnetic stimulation
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
RECRUITINGMayo Clinic in Rochester
Rochester, Minnesota, United States
RECRUITINGMyocardial 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
Time frame: change from baseline to post 6 months treatment
Peak Oxygen Consumption
Maximal oxygen consumption during maximal oxygen consumption
Time frame: 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
Time frame: change from baseline to post 6 months treatment
Time to angina onset during exercise
angina onset/threshold intensity during maximal exercise test
Time frame: change from baseline to post 6 months treatment
Exercise capacity (treadmill time)
total time on treadmill with maximal exercise test
Time frame: 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
Time frame: change from baseline to post 6 months treatment
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