Recruiting at 2 sites No phase Coronary Artery Disease

Clinical trial 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
The study wants to see if the Bioboosti device can help blood reach heart tissue better in patients with coronary artery disease.
Who it's for
Adults who have coronary artery disease and have had a heart attack.
What's involved
Participants will use the Bioboosti device as directed and may have blood flow tests and other routine visits.
Time commitment
The study lasts for a set period (not specified) and includes scheduled visits for device use and monitoring.

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
Who can 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.
What rules you out
  • 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 is enrolling

  • 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, but 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?

This study is enrolling now at Scottsdale, Arizona, United States; Rochester, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.