Heart Rhythm After Intravenous Methylprednisolone Administration
Graves DiseaseGraves Ophthalmopathy4 moreHigh doses of intravenous (iv.) glucocorticoids (GCs) are commonly used as a treatment for many autoimmune and inflammatory disorders. According to the European Group on Graves' Orbitopathy (EUGOGO) guidelines, intravenous methylprednisolone (IVMP) is an accepted first-line agent for active, moderate-to-severe and very severe Graves' orbitopathy (GO). This treatment is proven to be more efficient and safer than oral GCs. However, some patients may experience adverse cardiovascular effects during the administration of iv. GCs, which in rare cases may even be fatal. There are limited data, mostly obtained from case reports, reporting the occurrence of cardiac arrhythmias, acute myocardial infarction or heart failure. Increased heart rhythm (HR) has drawn attention of researchers as a possible adverse effect correlated with IVMP. During this study, investigators performed 72-hours of Holter ECG and ambulatory blood pressure monitoring (ABPM) to evaluate the impact of IVMP on patients with moderate-to-severe GO, concerning HR and blood pressure (BP) changes. In order to elucidate possible mechanism of observed changes, researchers investigated the level of potassium in serum and urine and catecholamines (epinephrine, norepinephrine) in serum. All patients were treated routinely according to EUGOGO recommendations with standard doses of methylprednisolone with standard recommended schedule. Inclusion criterion for the therapy was according to EUGOGO guidelines active, moderate-to-severe and active GO (12 pulses of IVMP 6x0.5g followed by 6x0.25g every week).
Tolerance of Centrifuge-induced Acceleration in Subjects With Diabetes Mellitus and Cardiac Arrhythmia...
Diabetes MellitusArrhythmias1 moreThe study will involve exposing individuals with a known past medical history of diabetes mellitus and/or cardiac arrhythmias to centrifuge-induced acceleration force (G-force) in the NASTAR AFTS-400 simulator to evaluate their response to such forces. Subjects without a history of these conditions will also undergo centrifuge-induced G-forces as controls. This study will contribute to the knowledge of how individuals with such medical conditions experience G-forces that may be experienced during commercial spaceflights.
EASYER (EpiAccess SYstem Registry) A Post Market Observational Registry
ArrhythmiasCardiacThe objective of the Registry is to provide post market clinical outcome and potential health economics data and confirm the continued safety of the EpiAccess system.
SIELLO Pilot Study for Comparison of Steroid Versus Non-Steroid Pacing Leads
ArrhythmiasCardiacThis investigation is designed to demonstrate the clinical efficacy and safety of the low-dose drug of the SIELLO leads in comparison to the non-steroid BPPU leads in a clinical investigation.
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
AdenovirusAnesthesia57 moreUnderstudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged <21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).
Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices
ArrhythmiasCardiacPatients with implanted cardiac devices who meet appropriate entrance criteria undergo clinically indicated Magnetic Resonance (MR) Imaging Studies using an established safety protocol.
Feasibility Study: Sleuth Monitoring System
ArrhythmiaSyncopeThe purpose of the study is to evaluate the safety and performance of the Sleuth Monitoring system.
Dysrhythmias During General Anesthesia in Children
ArrhythmiasCardiacTo describe the types and incidence of cardiac dysrhythmias that occur under anesthesia in the present anesthesia environment.
Long-Term Follow-Up of Patients Undergoing Catheter Ablation
ArrhythmiaThe purpose of this study is to assess the long-term effects of catheter ablation procedures performed at the OU Medical Center.
iPod and Other MP3 Players on ICDs and Pacemakers in Children
Heart BlockBradycardia2 moreUnlike phones, which are commonly held to the ear, music is now available via portable MP3 players and they can be held almost anywhere. Thaker et al state that Apple iPods cause pacemaker interference in 50% of their patients, with over-sensing in 20% of patients, telemetry interference in 29% of patients and pacemaker inhibition in 1.2% of patients. The mean age for their sample was 76.1 years +/- 8.6 years. We anticipate that a higher proportion of teenagers and children who have pacemakers use portable MP3 players than in the elderly adult population.We will include the first 100 patients with pacemakers and ICDs who consent for the prospective observational study a single tertiary care center. We intend to conduct a descriptive study, tabulating the number of times that a pacemaker or ICD has changes in the sensing thresholds, pacing thresholds, telemetry interference or pacemaker inhibition when exposed to a series of portable MP3 players at various distances. In addition, we will describe the nature and quantitative differences of those changes.