Ignite Creation Date:
2024-05-06 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 2:17 PM
Study NCT ID:
NCT05111288
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2021-10-27
Brief Title:
Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 CaCaM-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None