Coronary Artery DiseaseNCT05111288
Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia
A study testing Pulsed electromagnetic field therapy (PEMF) and Inactive Pulsed electromagnetic field therapy (PEMF) in people with Coronary Artery Disease and Myocardial Infarction, run by Mayo Clinic at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Infarction
- What is being tested?
- Pulsed electromagnetic field therapy (PEMF) and Inactive Pulsed electromagnetic field therapy (PEMF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 May 2022to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Sarah Devamani, 507-255-0876, devamani.sarah@mayo.edu
Briana Ziegler, 507-255-7125, zeigler.briana@mayo.edu
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Jordan Parks, 480-301-6616, parks.jordan@mayo.edu
Denise White, 480-342-6741, white.denise@mayo.edu
About this study
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).
Read the 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.
- Conditions
- Coronary Artery Disease, Myocardial Infarction
- Being tested
- Pulsed electromagnetic field therapy (PEMF), Inactive Pulsed electromagnetic field therapy (PEMF)
- Keywords
- Exercise induced ischemia
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed electromagnetic field therapy (PEMF)Device
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)Device
PEMF device that turns on but does not provide any electromagnetic stimulation
| Study group | Role | What they receive |
|---|---|---|
| Pulsed electromagnetic field (PEMF) therapy | Experimental | 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. Receives: Device: Pulsed electromagnetic field therapy (PEMF) |
| Sham PEMF therapy | Sham comparator | 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. Receives: Device: Inactive Pulsed electromagnetic field therapy (PEMF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial blood flow during chemical stress
assessment of myocardial blood flow using 13N-ammonia myocardial perfusion positron emission tomography (PET) to quantify blood flow during chemical induced stress
Measured: change from baseline to post 6 months treatment
Secondary outcomes (5)
Peak Oxygen Consumption
Maximal oxygen consumption during maximal oxygen consumption
Measured: change from baseline to post 6 months treatment
Seattle Angina Questionnaire
questionnaire to assess angina symptoms where scores range from 0- 100 and higher scores mean better outcomes or less angina symptoms
Measured: change from baseline to post 6 months treatment
Time to angina onset during exercise
angina onset/threshold intensity during maximal exercise test
Measured: change from baseline to post 6 months treatment
Exercise capacity (treadmill time)
total time on treadmill with maximal exercise test
Measured: change from baseline to post 6 months treatment
New York Heart Association Heart Failure Functional classification
New York Heart Association classification on functional ability of heart failure patients based on symptoms
Measured: change from baseline to post 6 months treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start18 May 2022
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Courtney M. Wheatley, Mayo Clinic
- Investigators
- Courtney Wheatley-Guy, PhD, Principal investigator, Mayo ClinicBruce Johnson, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111288
- Sponsor's protocol ID
- 19-008996
- Status last verified
- Sep 2026
- First submitted
- 27 Oct 2021
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia
- ClinicalTrials.gov ID
- NCT05111288
- Acronym / sponsor ID
- 19-008996
- Conditions
- Coronary Artery Disease, Myocardial Infarction
- Keywords
- Exercise induced ischemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed electromagnetic field (PEMF) therapy | Experimental | Device: Pulsed electromagnetic field therapy (PEMF)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 PEMF therapy | Sham comparator | Device: Inactive Pulsed electromagnetic field therapy (PEMF)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Pulsed electromagnetic field (PEMF) therapy |
| Inactive Pulsed electromagnetic field therapy (PEMF)PEMF device that turns on but does not provide any electromagnetic stimulation | Device | Sham PEMF therapy |
Primary outcome
Myocardial blood flow during chemical stress
Time frame: change from baseline to post 6 months treatment
assessment of myocardial blood flow using 13N-ammonia myocardial perfusion positron emission tomography (PET) to quantify blood flow during chemical induced stress
5 secondary outcomes
Peak Oxygen Consumption
Time frame: change from baseline to post 6 months treatment
Seattle Angina Questionnaire
Time frame: change from baseline to post 6 months treatment
Time to angina onset during exercise
Time frame: change from baseline to post 6 months treatment
Exercise capacity (treadmill time)
Time frame: change from baseline to post 6 months treatment
New York Heart Association Heart Failure Functional classification
Time frame: change from baseline to post 6 months treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Courtney Wheatley-Guy, PhD principal investigator
Mayo Clinic
Bruce Johnson, PhD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed electromagnetic field therapy (PEMF) and Inactive Pulsed electromagnetic field therapy (PEMF) in people with Coronary Artery Disease and Myocardial Infarction, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial blood flow during chemical stress (time frame: change from baseline to post 6 months treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.