NCT05111288 Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia
| NCT ID | NCT05111288 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-05-18 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2022-05-18 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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).
Contact & Investigator
Courtney Wheatley-Guy, PhD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT05111288 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05111288 currently recruiting?
Yes, NCT05111288 is actively recruiting participants. Visit ClinicalTrials.gov or contact Mayo Clinic to inquire about joining.
Where is the NCT05111288 trial being conducted?
This trial is being conducted at Scottsdale, United States, Rochester, United States.
Who is sponsoring the NCT05111288 clinical trial?
NCT05111288 is sponsored by Mayo Clinic. The principal investigator is Courtney Wheatley-Guy, PhD at Mayo Clinic. The trial plans to enroll 120 participants.