View clinical trials related to Syncope.
Filter by:The CNA-FWRD Registry is an international prospective observational multicenter registry of patients with symptomatic vasovagal syncope and bradyarrhythmias managed under routine care by medical therapy and radiofrequency catheter ablation of ganglionated plexi or permanent pacemaker implantation.
This registry aims to collect patient data on cardioneuroablation for vasovagal syncope from multiple centers in France. The aim is to evaluate success rates, compare techniques and help institutions set up their own cardioneuroablation program
This study seeks to provide evidence that use of Philips mobile cardiac outpatient telemetry (MCOT) devices may improve patient care for patients who present to emergency departments (EDs) with syncope, which is a temporary loss of consciousness also known as fainting or who present experiencing a near temporary loss of consciousness (near syncope). It is set up as a random controlled trial, which means research participants will be randomly assigned to receiving the device or usual care. Patients 50 years or older who come to the ED of Carilion Roanoke Memorial Hospital will be screened by study team members for unexplained syncope or near syncope across three ED dispositions: hospital admission, emergency department clinical decision unit admission (ED CDU) and emergency department. After consent, subjects will be enrolled and randomized, via REDCap randomization, in the study. At the time of subject discharge the MCOT device will be placed on the chest for the arm of intervention patients (for subjects who were admitted, the research study team will follow the patient's clinical course and placement of the device will occur at discharge); subjects will also receive brief instruction on the care and maintenance of the device and a patient education guide. The research team will contact the subjects for a telephone follow up at 14 and 30 days post-enrollment. The study will establish the efficacy of mobile cardiac outpatient telemetry in comparison to observation telemetry. Research objectives are to 1) Measure the time to medical intervention in patients with unexplained syncope or near syncope fitted with a Philips MCOT at the time of hospital discharge compared to patients treated with usual care for unexplained syncope or near syncope; and 2) Measure the time to arrhythmia diagnosis in patients with unexplained syncope or near syncope fitted with a Philips MCOT at the time of hospital discharge compared to patients treated with usual care for unexplained syncope or near syncope.
The Study To Understand Tilt Tests versus Extended Recordings (STUTTER, POST 10) will test the hypothesis that first performing a diagnostic HUT in older patients with syncope of unknown cause will provide earlier and more diagnoses than inserting an ICM.
About 20% of adults faint recurrently. These patients are often highly symptomatic, have problems with employment and driving, can be injured, and have poor quality of life. There are few therapies that have withstood the test of randomized clinical trials. the investigators will conduct a prospective, randomized, parallel, double-blind, proof-of-concept study that tests the hypothesis that serotonin 5HT3 receptor inhibition with ondansetron prevents tilt-induced vasovagal syncope (VVS) and pre-syncope in patients with clinical VVS. A total of 70 patients with quantitative clinical diagnostic criteria for VVS and at least 1 syncopal spell in the preceding year will be randomized in a double-blind acute phase 2 study to ondansetron 8 mg PO BID x 2 doses or matching placebo. The endpoint will be presyncope or syncope associated with diagnostic hemodynamic changes. These data should provide useful preliminary data as a foundation on which to conduct a subsequent randomized clinical trial.
Identifying the mechanism of non-cardiac syncope is the essential prerequisite for an effective personalized therapy. Aim of this multicentre, prospective, cross-sectional, observational study is to assess effectiveness and diagnostic yield of a two-step standardized assessment which consists of 24-hour ambulatory blood pressure monitoring (ABPM) and of tilt-table Short Cardiovascular Autonomic Function Battery (SCAFB) which consists in carotid sinus massage (CSM), limited to patients ≥40-year-old, standing test, and head-up tilt test (HUT) performed one after the other in an uninterrupted sequence as a single procedure on a tilt table
At least 5% of patients with vasovagal syncope also have Sleep Syncope. Patients awake from sleep with profound malaise and gastrointestinal vagal symptoms. About 75% have severe nausea and about 40% have lower abdominal cramps. Some faint while supine, but most find their symptoms so severe that they rise quickly and hurry to the bathroom. Sometime either on the way to the toilet, near it, or shortly afterwards they faint. The nausea is followed by vomiting, and the cramps by watery diarrhea. After relief the patients remain presyncopal, diaphoretic, and tired. Almost all patients also have clinical vasovagal syncope during daytime hours. The cause of this is unknown. Orthostatic stress cannot be a factor in triggering the event, and in isolated case reports it occurs during non-REM sleep. There is no classic provocative situation of pain, the sight of trauma, or the presence of medical settings. These suggest the importance of central processes and the reduced likelihood that strategies that target maintaining preload (such as with midodrine and fludrocortisone) would be helpful. As well, midodrine is avoided during the night. Recently the investigators reasoned that if the investigators could rapidly suppress the nausea patients could remain supine, wait out the nausea, and not faint with orthostatic stress. Ondansetron is a potent anti-nausea medication that has rapidly dissolving preparations. Nine patients were instructed to keep one at the bedside, insert it upon waking up with nausea, remain in bed, and raise their legs (if possible). There was partial success with ondansetron 4 mg and complete success with ondansetron 8 mg. This remarkable but anecdotal observation requires formal testing. Research Objectives: the investigators will test the hypothesis that ondansetron 8 mg prn sublingually on awakening with moderate to severe nausea prevents loss of consciousness in patients with prior Sleep Syncope who awaken with malaise and nausea. Study Design & Methodology: The main study will be a placebo-controlled, double-blind, randomized, crossover clinical trial. The primary outcome will be the progression of awakening with nausea to syncope. Thirty patients with Sleep Syncope will be randomized 1:1 to receive packages of either ondansetron 8 mg sublingual tablets or matching placebo. They will each receive 3 boxes of 10 tabs, with refills available if needed. Each crossover period will last 6 months. In a substudy the investigators will test whether the predominant disturbed physiology is bradycardia, decreased venous return, or decreased systemic vascular resistance. This will be assessed using a unique, small, wearable blood pressure sensor that can be rapidly donned on the ear. It records heart rate and beat-to-beat waveforms, which permit estimating stroke volume, systemic vascular resistance, and cardiac output. the investigators will record these variables in all patients continuously from when the device is put on until 30 minutes afterwards. the investigators hypothesize that unlike during syncope provoked by head-up tilt testing, here there will be no decrease in preload until patients arise, and that the main physiologic disturbance during syncope is hypotension due to decreased preload superimposed on heart rate collapse. Anticipated Outcomes: If successful, this research would be i) the first to report a well-tolerated and highly effective treatment for most sleep syncope, and ii) the first to report the physiology of brain-initiated vasovagal syncope in the community outside a laboratory environment.
The study will systematically evaluate how an emergency manual-a collection of checklists and fact sheets-affects the performance of resuscitation teams during the management of priority one patients in an emergency department.
Background: Autonomic system modification is an established therapeutic approach that has been increasingly used for the treatment of vagal-related symptomatic bradycardia, such as cardio-inhibitory vasovagal syncope1-12. Although convincing results had been reported from small populations, a large randomized study providing robust evidence on the efficacy of this approach has not yet been performed. Hypothesis: Cardiac autonomic system modification is effective for the treatment of vagal-related symptomatic bradycardia, and is associated better clinical results as compared to placebo.
Background: Syncope is defined as a sudden, brief loss of consciousness (LOC) followed by a rapid complete recovery. It accounts for 160,000 emergency department (ED) visits each year in Canada. Despite this, few people are hospitalized (~15%) and even fewer will die (~1%). Two-thirds of patients with syncope arrive at the ED by calling 911. There are many causes of syncope. Identifying patients at low risk for bad outcomes would allow paramedics to safely determine which patients need care in the ED from those who can remain home. The research team recently developed the Canadian Prehospital Syncope Risk Score (CPSRS) which accurately identified patients at low risk for 30-day serious outcomes. Objective: The goal of this study is to validate the accuracy of the CPSRS in the prehospital setting or refine if needed to predict the risk of 30-day serious outcomes for patients with syncope. Methods: The research team will enroll patients with syncope from five paramedic services across Canada (British Columbia - Vancouver and Kelowna areas only, London-Middlesex, York Region, Frontenac, and Ottawa). The research team will exclude patients <18 years old, LOC >5 minutes, changes in mental status from baseline, alcohol or drug intoxication, or language barrier. Paramedics will fill out a study data collection form with the CPSRS items and additional data should the tool need refinement. The data will be entered into a secure database and will assess patient outcomes (death and potentially life-threatening medical conditions) at 30 days. The research team will examine model accuracy using standard prediction measures and look to improve model accuracy if needed. The research team expects to enroll 4875 patients over a 1-year recruitment period based on annual call volumes. Expected Outcomes: Once validated, the tool could reduce the number of patients transported to the hospital by identifying those at low risk. This would improve patient-oriented care, while at the same time saving valuable paramedic and ED resources.