Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT05111288
Status
Recruiting
Apply to this trial

Conditions

  • Coronary Artery Disease
  • Myocardial Infarction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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 Details

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).

Key Dates

Start date
May 18, 2022
Status verified
Dec 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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.

Primary Outcome Measure

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

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259
Jordan Parks
[email protected]
480-301-6616
Denise White
[email protected]
480-342-6741
Courtney Wheatley-Guy, PhD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Sarah Devamani
[email protected]
507-255-0876
Briana Ziegler
[email protected]
507-255-7125
Bruce Johnson, PhD (PRINCIPAL_INVESTIGATOR)

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