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임상시험 NCT05111288은(는) 관상동맥 질환, 심근경색에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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카드 뷰
Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia
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임상시험 NCT05111288은(는) 관상동맥 질환, 심근경색에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2022년 5월 18일에 시작되어 120명의 참여자를 모집하고 있습니다. 메이요 클리닉이(가) 진행하며, 2025년 11월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2024년 12월 5일에 갱신되었습니다.
간단한 개요
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).
상세한 설명
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.
공식 제목
Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia
질환/상태
관상동맥 질환심근경색기타 연구 식별자
- 19-008996
NCT 번호
실제 연구 시작일
2022-05-18
최신 업데이트 게시
2024-12-05
예상 연구 완료일
2025-11
계획된 등록 인원
120
연구종류
중재연구
단계/상
해당 없음
상태
모집중
키워드
Exercise induced ischemia
주요 목적
기타
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
사중맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Pulsed 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. | 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. |
거짓 대조군Sham 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. | Inactive Pulsed Electromagnetic Field Therapy (PEMF) PEMF device that turns on but does not provide any electromagnetic stimulation |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Myocardial blood flow during chemical stress | assessment of myocardial blood flow using 13N-ammonia myocardial perfusion positron emission tomography (PET) to quantify blood flow during chemical induced stress | change from baseline to post 6 months treatment |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Peak Oxygen Consumption | Maximal oxygen consumption during maximal oxygen consumption | change from baseline to post 6 months treatment |
Seattle Angina Questionnaire | questionnaire to assess angina symptoms where scores range from 0- 100 and higher scores mean better outcomes or less angina symptoms | change from baseline to post 6 months treatment |
Time to angina onset during exercise | angina onset/threshold intensity during maximal exercise test | change from baseline to post 6 months treatment |
Exercise capacity (treadmill time) | total time on treadmill with maximal exercise test | change from baseline to post 6 months treatment |
New York Heart Association Heart Failure Functional classification | New York Heart Association classification on functional ability of heart failure patients based on symptoms | change from baseline to post 6 months treatment |
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- 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).
연구 책임자
Courtney M. Wheatley, 책임연구자, Principal Investigator, Mayo Clinic
연락처 정보가 없습니다.
2 1개국에 임상시험 장소
Arizona
Mayo Clinic in Arizona, Scottsdale, Arizona, 85259, United States
Jordan Parks, 연락처, 480-301-6616, [email protected]
Denise White, 연락처, 480-342-6741, [email protected]
Courtney Wheatley-Guy, PhD, 책임연구자
모집중
Minnesota
Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States
Sarah Devamani, 연락처, 507-255-0876, [email protected]
Briana Ziegler, 연락처, 507-255-7125, [email protected]
Bruce Johnson, PhD, 책임연구자
모집중