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New treatment option for Coronary Artery Disease
Official title Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia
ClinicalTrials.gov ID: NCT05111288
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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).
See the full eligibility 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.