Recruiting

Bioboosti

Sponsor:

Mayo Clinic

Code:

NCT05111288

Conditions

Coronary Artery Disease

Myocardial Infarction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pulsed electromagnetic field therapy (PEMF)

Inactive Pulsed electromagnetic field therapy (PEMF)

Study Details

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).

Conditions

Coronary Artery Disease

Myocardial Infarction

Study ID

NCT05111288

Start date

May 18, 2022

Status verified date

Dec, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Pulsed electromagnetic field (PEMF) therapy

A portable PEMF device will be utilized. For the PEMF group, the device includes adjustable magnetic field strength range (X-axis: 0.22±0.05 mT, Y-axis: 0.20±0.05 mT and Z-axis: 0.06±0.02 mT) and working frequency (30±3Hz). This magnetic strength range and frequency will be maintained during 180 days of the study period. The subjects will be instructed to use their device three times per day: providing micromagnetic emitting on both hands (palms) during morning, afternoon and evening/night sessions. Each session takes 16 min (both hands, 8 min per hand) and thus subjects are exposed to therapy for 48 min per day. Subjects will use the device as outlined continuously up through the final days of testing.

sham comparator: Sham PEMF therapy

The sham PEMF devices are modified to deliver no micromagnetic field when turned on. The subjects will be instructed to use their device three times per day: providing micromagnetic emitting on both hands (palms) during morning, afternoon and evening/night sessions. Each session takes 16 min (both hands, 8 min per hand) and thus subjects are exposed to therapy for 48 min per day. Subjects will use the device as outlined continuously up through the final days of testing.

Interventions

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

Primary outcome measure

  • Myocardial blood flow during chemical stress [ Time Frame: change from baseline to post 6 months treatment ]

Central Contacts and Locations

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Jordan Parks

480-301-6616parks.jordan@mayo.edu

Denise White

480-342-6741white.denise@mayo.edu

Principal Investigator:

Courtney Wheatley-Guy, PhD

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Sarah Devamani

507-255-0876devamani.sarah@mayo.edu

Briana Ziegler

507-255-7125zeigler.briana@mayo.edu

Principal Investigator:

Bruce Johnson, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Keywords

  • Exercise induced ischemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-12-15.