View clinical trials related to Syncope.
Filter by:Syncope affects about 50% of Canadians, is the cause of 1 - 2% of all emergency room visits, and probably is responsible for CDN $250 million in health care spending each year. It is associated with decreased quality of life, trauma, loss of employment, and limitations in daily activities. It is a particular problem for older people, partly because of increased frailty, and partly because of a difficult differential diagnosis. One of the causes in older adults is intermittent complete heart block in the setting of bifascicular heart block, but they may also faint due to a variety of tachyarrhythmias, sick sinus syndrome, and several neurally mediated syncopes. Often treatment decisions should be made before the true cause is apparent.
The purpose of this research is to simplify the standard recording system of the heart rhythm. The investigators desire to improve the ease of monitoring the cardiac rhythm for 24 hours. The investigators intent is to use a very small, innovative monitoring patch system that relieves the patient of wearing a cumbersome and uncomfortable recording system. This research trial will carry the title "The Simple ECG Monitoring" for Comparison of a Sternal ECG Recording System with a Standard ECG Recording System for Holter Monitoring. The data from the investigational device is for comparative purposes only. It will not be used by medical personnel for study subject treatment or diagnostic purposes.
Context The investigators recently demonstrated a highly significant increase in muscarinic receptor density in the myocardium of infants deceased from sudden infant death syndrome (SIDS) compared to those of infants deceased from identified causes 1. Muscarinic receptor overexpression was found in all SIDS samples studied to date. It was associated with an average increase in acetylcholinesterase activity, appearing as a compensatory mechanism to oppose the cardiac muscarinic receptor overexpression. Similar vago-cardiac abnormalities were detected in a rabbit model of vagal hyperreactivity that the investigators first described some years ago2. In these hyperreactive animals, expression of muscarinic receptors was also enhanced in blood white cells. Noticeably, the pattern of changes in these cells paralleled the pattern of changes in the heart. Thus, muscarinic abnormalities in cardiac tissues could be inferred with high confidence from those measured in lymphocytes.This was the first report of a vago-cardiac abnormality in sudden infant death syndrome. The investigators findings also provided original and important perspectives for the identification and therapeutic management of infants at risk of sudden death. As such, the publication of the investigators work raised a major interest from the population and from the scientific and medical communities, in particular cardio-pediatricians. ObjectivesThe objective of the present clinical project is to validate, in human lymphocytes, muscarinic receptor expression level (assessed by quantitative RT-PCR) as a circulating biomarker of autonomic nervous system dysfunction and more specifically, of vagal hyperactivity and of risk of sudden death. The project will include 2 major items, conducted in parallel:1. evaluation of the muscarinic receptor expression in lymphocytes from adults with vagal syncopes (n=60 patients from an existing file versus 60 controls) (Cardiology unit + Clinical Investigation Centre (CIC) + Laboratory of Neurobiology and Cardiovascular Pharmacology); 2. evaluation of the muscarinic receptor expression in lymphocytes from children with vagal syncopes (n=60 versus 60 controls) (Pediatry unit + Clinical Investigation Centre + Laboratory of Neurobiology and Cardiovascular Pharmacology).PerspectivesThis project represents the first step of validation of a circulating marker of vagal hyperactivity and of risk of SIDS in human. Once this step is completed, the investigators will start with the prospective study " muscarinic receptor expression in lymphocytes and SIDS " (cord blood collected at birth and follow up of the new-borns) (Maternity ward + CIC + Laboratory of Neurobiology and Cardiovascular Pharmacology). Then therapeutic preventive management becomes a realistic objective. A therapeutic clinical study will then be started with atropinic drugs, in order to test their potential protective action against sudden death. The final objective of the investigators research is the prevention of SIDS through i) identification - as soon as birth - of new-borns at high risk and ii) appropriate prophylactic therapy. The investigators work also opens exciting perspectives in the field of the still poorly understood vagal disorders in children and adults such as vagal pauses.1 Livolsi et coll, Plos One 5, e9464, 2010 ; 2 Livolsi et coll, Circulation 106, 2301-2304, 2002
The purpose of this study is to assess efficacy of prolonged Full Disclosure electrocardiogram (ECG) monitoring and signal analysis using advanced telemetric technology to diagnose syncope in comparison with standard diagnostic procedure
The investigators hypothesis is that a significant number of patients may remain without specific cause and have recurrent syncope with its associated physical and mental morbidity.
The One Hospital ClinicalService Project is an integrated system composed by a network of International Hospital Departments, a clinical data repository and a shared environment for the collection, management, analysis and reporting of clinical and diagnostics data from patients treated by Medtronic therapies or patients wearing Medtronic implantable devices used within their intended use. The One Hospital ClinicalService is composed by a suite of systematic, data-guided activities designed to bring about immediate improvements in health delivery in particular settings. Data are prospectively collected. An independent committee of physicians prospectively identifies key clinical questions on a yearly basis for development of quality improvement activities, analyses and publications. A charter, approved by Hospital Istitutional Review Boards or other Hospital entities, assigns the ownership of data to the centers and governs the conduct of the project and the relationship of the scientific committee and Medtronic. Hospital is the data controller, while Medtronic is the data processor on behalf of the Hospital. Data collected for quality improvement purposes may be mined to perform clinical research.
Syncope, defined as a transient loss of consciousness, accounts for over 700,000 annual U.S. emergency department visits and may herald a life-threatening condition in older adults (ageā„60 years). Existing risk prediction instruments cannot reliably identify who among such older patients can safely be discharged home from an emergency department. As a result, the majority of older patients without a clear cause for syncope are hospitalized for diagnostic evaluation. However, current admission practices are characterized by low diagnostic yield, do not clearly improve outcomes, and account for over $2.4 billion in annual hospital costs. Most admitted patients are discharged within 48 hours, and approximately 50% of patients do not have an identified cause of syncope after their hospitalization. The implementation of an expedited and standardized Emergency Department Observation Syncope Protocol (EDOSP) may safely reduce hospitalization of older patients with syncope. The investigators propose a pilot randomized trial to implement and evaluate EDOSP at two emergency departments. This study has the following exploratory Specific Aims: 1. To compare admission rates and length-of-stay associated with EDOSP to standard care. 2. To compare serious outcomes rates associated with EDOSP to standard care. 3. To compare quality-of-life associated with EDOSP to standard care. 4. To compare the incremental costs and cost-effectiveness of EDOSP to standard care. Over a one-year period, 120 intermediate-risk older adults who present with syncope at the two study sites will be randomized to 1 of 2 arms: 1.) intervention arm: expedited and standardized EDOSP care; or 2.) control arm: routine care consisting of admission from the emergency department. If this pilot trial suggests that EDOSP can safely reduce admissions, then the investigators will plan a larger study powered to evaluate clinical, quality-of-life, and economic outcomes. A successful EDOSP intervention would have important clinical policy implications and improve the emergency department care of older adults with syncope.
The investigators want to look at how patients admitted after passing out (syncope) or nearly passing out (pre-syncope) do after going home and how many of them remain free of symptoms of syncope or pre-syncope.
The goal of this IDE clinical study is to evaluate the quality of the cardiac signal recordings obtained by the St. Jude Medical (SJM) Confirm Implantable Cardiac Monitor (device).
The purpose of the study is to evaluate the safety and performance of the Sleuth Monitoring system.