beta
Trial Radar IA
Lo studio clinico NCT05111288 per Malattia dell'arteria coronaria, Infarto miocardico è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
Un studio corrisponde ai criteri del filtro
Vista a schede

Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT05111288 è uno studio interventistico per Malattia dell'arteria coronaria, Infarto miocardico, attualmente in arruolamento. Avviato il 18 maggio 2022, prevede di arruolare 120 partecipanti. Sotto la guida di la Clinica Mayo, dovrebbe concludersi entro il 1 novembre 2025. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 5 dicembre 2024.
Sommario breve
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).
Descrizione dettagliata
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.
Titolo ufficiale

Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia

Condizioni
Malattia dell'arteria coronariaInfarto miocardico
Altri ID dello studio
  • 19-008996
Numero NCT
Data di inizio (effettiva)
2022-05-18
Ultimo aggiornamento pubblicato
2024-12-05
Data di completamento (stimata)
2025-11
Arruolamento (previsto)
120
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
Exercise induced ischemia
Scopo principale
Altro
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Quadruplo
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentalePulsed 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.
Comparatore simulatoSham 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
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
  • 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).
Parte responsabile dello studio
Courtney M. Wheatley, Investigatore principale, Principal Investigator, Mayo Clinic
Nessun dato di contatto
2 Centri dello studio in 1 paesi

Arizona

Mayo Clinic in Arizona, Scottsdale, Arizona, 85259, United States
Jordan Parks, Contatto, 480-301-6616, [email protected]
Denise White, Contatto, 480-342-6741, [email protected]
Courtney Wheatley-Guy, PhD, Investigatore principale
In arruolamento

Minnesota

Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States
Sarah Devamani, Contatto, 507-255-0876, [email protected]
Briana Ziegler, Contatto, 507-255-7125, [email protected]
Bruce Johnson, PhD, Investigatore principale
In arruolamento