Grant: Project Grant

Syncope (fainting) is common and accounts for ~160,000 emergency department (ED) visits across Canada annually. 10% will have serious conditions identified within 30 days (blood clots in the lung, heart attack, irregular heart rhythm requiring pacemaker/defibrillator) and/or will die. One-third/half will not be evident during the ED visit leading to prolonged observation, hospitalization, and inappropriate discharge of higher-risk patients. We completed two large studies enrolling 8176 patients and found that of the serious conditions identified after the ED visit, 68.8% were arrhythmias (heart rhythm abnormalities) which were identified up to two weeks later and half of all hospitalizations were for heart monitoring. We developed a robust tool, the Canadian Syncope Risk Score (CSRS) for predicting 30-day serious events after ED discharge. We completed a pilot study with 15-day monitoring of 70 at-risk patients (CSRS score >=3) and found that such monitoring is feasible, safe, acceptable, and can lead to the identification of important arrhythmias. The main objective is to evaluate if 15-day live cardiac monitoring will improve the identification of an arrhythmia that requires treatment compared to usual care. We will enroll consenting adult patients presenting to 13 Canadian EDs within 24 hours of their syncope, who are at-risk (CSRS >=3) and discharged. Patients will be randomly assigned to usual care (no intervention) or a 15-day monitoring device that transmits heart rhythm continuously to a monitoring station. Patients with life-threatening arrhythmias will be advised to call 911 or an ambulance dispatched to their residence, and those with urgent arrhythmias will have timely follow-up. We will collect data on arrhythmia requiring treatment within 15 days, any serious outcomes, and patient satisfaction at 30 days, and 1-year outcomes. We estimate that 580 patients (290 patients per arm) will be needed to prove that 15-day monitoring is better than usual care.