Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia

Coronary Artery Disease Clinical Trial

Official title:

Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05111288
• Other study ID #: 19-008996
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2022
• Est. completion date: November 2024

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Coronary Artery Disease
• Infarction
• Ischemia
• Myocardial Infarction
• Myocardial Ischemia

Intervention

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.
• Inactive Pulsed electromagnetic field therapy (PEMF)
PEMF device that turns on but does not provide any electromagnetic stimulation

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Peak Oxygen Consumption	Maximal oxygen consumption during maximal oxygen consumption	change from baseline to post 6 months treatment
Secondary	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
Secondary	Time to angina onset during exercise	angina onset/threshold intensity during maximal exercise test	change from baseline to post 6 months treatment
Secondary	Exercise capacity (treadmill time)	total time on treadmill with maximal exercise test	change from baseline to post 6 months treatment
Secondary	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

External Links

•   Mayo Clinic Clinical Trials