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L'essai clinique NCT05111288 pour Maladie de l'artère coronaire, Infarctus du myocarde est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia

En recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'étude clinique NCT05111288 est un essai interventionnel pour Maladie de l'artère coronaire, Infarctus du myocarde. Son statut actuel est : en recrutement. L'étude a débuté le 18 mai 2022 et vise à recruter 120 participants. Dirigé par la Clinique Mayo, l'essai devrait être terminé d'ici le 1 novembre 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 5 décembre 2024.
Résumé succinct
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).
Description détaillée
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.
Titre officiel

Influence of Pulse Electromagnetic Field Therapy on Myocardial Ischemia

Conditions
Maladie de l'artère coronaireInfarctus du myocarde
Autres identifiants de l'essai
  • 19-008996
Numéro NCT
NCT05111288
Date de début (réel)
2022-05-18
Dernière mise à jour publiée
2024-12-05
Date de fin (estimée)
2025-11
Inscription (estimée)
120
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Exercise induced ischemia
Objectif principal
Autre
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Quadruple aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalPulsed 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.
Comparateur facticeSham 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
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
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
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
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
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  • 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).
Mayo Clinic logoClinique Mayo866 essais cliniques actifs à explorer
Partie responsable de l'essai
Courtney M. Wheatley, Investigateur principal, Principal Investigator, Mayo Clinic
Aucune donnée de contact disponible
2 Centres de l'essai dans 1 pays

Arizona

Mayo Clinic in Arizona, Scottsdale, Arizona, 85259, United States
Jordan Parks, Contact, 480-301-6616, [email protected]
Denise White, Contact, 480-342-6741, [email protected]
Courtney Wheatley-Guy, PhD, Investigateur principal
En recrutement

Minnesota

Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States
Sarah Devamani, Contact, 507-255-0876, [email protected]
Briana Ziegler, Contact, 507-255-7125, [email protected]
Bruce Johnson, PhD, Investigateur principal
En recrutement