Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia

Обзор

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).

Подробное описание

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. PEMF therapy was originally used clinically to manage osteoarthritis related pain and stiffness and to augment bone healing. In addition, recent research has explored the beneficial therapeutic effect of PEMF on microvasculature and circulation. More recently, research interest has been toward the effect of PEMF on various targets, including peripheral vascular function and blood flow. It has been suggested that PEMF therapy enhances the binding of free calcium (Ca2+) to calmodulin (CaM) and this phenomenon might improve tissue repair and pain and moreover other studies suggested an effect of PEMF on Ca/CaM-dependent nitric oxide (NO) signaling pathway, which is one of the major components for controlling vascular tone and blood pressure (BP, figure 1). The investigators have recently demonstrated that in subjects with metabolic syndrome with hypertension, 12 weeks of daily therapy using Bioboosti tended to lower BP and raise plasma NO levels as well as improve flow mediated dilation. In a small pilot study from China, subjects with a history of diffuse coronary disease and evidence of myocardial ischemia performed radionuclide SPECT before and after PEMF therapy or control. In this small pilot study there was evidence of reduced ischemia in the treatment group vs a control group. Thus the focus of this proposal is to pursue a larger clinical trial to demonstrate the benefits of PEMF therapy using the Bioboosti PEMF device to reduce the ischemic burden in patients with coronary artery disease.

Вмешательства

• Устройство Pulsed electromagnetic field therapy (PEMF)
  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.
• Устройство Inactive Pulsed electromagnetic field therapy (PEMF)
  PEMF device that turns on but does not provide any electromagnetic stimulation

Первичные конечные точки

• Myocardial blood flow during chemical stress [Срок оценки: change from baseline to post 6 months treatment]

Вторичные конечные точки (5)

• Peak Oxygen Consumption [Срок оценки: change from baseline to post 6 months treatment]
• Seattle Angina Questionnaire [Срок оценки: change from baseline to post 6 months treatment]
• Time to angina onset during exercise [Срок оценки: change from baseline to post 6 months treatment]
• Exercise capacity (treadmill time) [Срок оценки: change from baseline to post 6 months treatment]
• New York Heart Association Heart Failure Functional classification [Срок оценки: change from baseline to post 6 months treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Другое

Центры проведения

США · 2 центра

• Mayo Clinic in Arizona — Scottsdale
• Mayo Clinic in Rochester — Rochester

Идентификаторы

NCT: NCT05111288 · 19-008996

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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