RecruitingNot ApplicableNCT05111288

Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia

Sponsor

Mayo Clinic

Enrollment

120 participants

Start Date

May 18, 2022

Study Type

INTERVENTIONAL

Conditions

Myocardial Infarction Coronary Artery Disease

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria14

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).

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Interventions

DEVICEPulsed 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.

DEVICEInactive Pulsed electromagnetic field therapy (PEMF)

PEMF device that turns on but does not provide any electromagnetic stimulation