Clinical trial NCT05111288: Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia
Official title: Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Myocardial Infarction
Keywords: Exercise induced ischemia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Myocardial blood flow during chemical stress
timeFrame: change from baseline to post 6 months treatment
Secondary outcomes:
measure: Peak Oxygen Consumption
timeFrame: change from baseline to post 6 months treatment
measure: Seattle Angina Questionnaire
timeFrame: change from baseline to post 6 months treatment
measure: Time to angina onset during exercise
timeFrame: change from baseline to post 6 months treatment
measure: Exercise capacity (treadmill time)
timeFrame: change from baseline to post 6 months treatment
measure: New York Heart Association Heart Failure Functional classification
timeFrame: change from baseline to post 6 months treatment
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Courtney Wheatley-Guy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Bruce Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References: