Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
Mayo Clinic in Arizona
RECRUITING
Scottsdale
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Time Frame
Start Date: 2022-05-18
Estimated Completion Date: 2026-08
Participants
Target number of participants: 120
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov