Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Pulsed electromagnetic field therapy (PEMF)
DevicePulsed 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)
DevicePEMF device that turns on but does not provide any electromagnetic stimulation
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Pulsed electromagnetic field (PEMF) therapyExperimental treatment 1 intervention
Group B: Sham PEMF therapySham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
change from baseline to post 6 months treatmentSecondary outcomes
1
Peak Oxygen Consumption
Maximal oxygen consumption during maximal oxygen consumption
Time frame
change from baseline to post 6 months treatment2
Seattle Angina Questionnaire
questionnaire to assess angina symptoms where scores range from 0- 100 and higher scores mean better outcomes or less angina symptoms
Time frame
change from baseline to post 6 months treatment3
Time to angina onset during exercise
angina onset/threshold intensity during maximal exercise test
Time frame
change from baseline to post 6 months treatment4
Exercise capacity (treadmill time)
total time on treadmill with maximal exercise test
Time frame
change from baseline to post 6 months treatmentSponsors and contacts
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Source ClinicalTrials.gov