NCT05111288

Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	Inactive Pulsed electromagnetic field therapy (PEMF)	PEMF device that turns on but does not provide any electromagnetic stimulation

Timeline

• Start date: 2022-05-18
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2021-11-08
• Last updated: 2025-12-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study