Effects of Pulsed Electromagnetic Field Therapy on Heart Blood Flow
Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia
NA · Mayo Clinic · NCT05111288
This study is testing if a device that uses pulsed electromagnetic field therapy can improve blood flow to the heart and help people with coronary artery disease feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Locations | 2 sites (Scottsdale, Arizona and 1 other locations) |
| Trial ID | NCT05111288 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of a device called Bioboosti, which uses pulsed electromagnetic field (PEMF) therapy, on improving blood flow to the heart in individuals with coronary artery disease. PEMF therapy is a noninvasive treatment that employs low energy electromagnetic fields to stimulate biological systems. The study aims to evaluate the therapy's effectiveness in enhancing circulation and reducing symptoms of myocardial ischemia in patients who are not candidates for surgical interventions. Participants will undergo a cardiopulmonary exercise test to assess their condition before and after treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with known cardiac ischemia who are not eligible for revascularization procedures.
Not a fit: Patients with severe lung disease, significant arrhythmias, or those unable to exercise due to orthopedic limitations may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a noninvasive treatment option to improve heart function and quality of life for patients with coronary artery disease.
How similar studies have performed: Previous studies have shown promising results with PEMF therapy in improving vascular function, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Scottsdale, Arizona and 1 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (RECRUITING)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Courtney Wheatley-Guy, PhD — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Disease, Myocardial Infarction, Exercise induced ischemia