Multicenter Randomized Clinical Trial to Assess the Clinical Benefit of 24-hour in Hospital Observation of Syncope Patients Admitted to the Cardiac Emergency Room
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 640
- 试验地点
- 1
- 主要终点
- Incidence of Ventricular tachycardia:
研究概览
简要总结
Syncope is very common and has a broad differential diagnosis. Guidelines on syncope recommend to apply guideline based syncope algorithm (SA) to identify low- / intermediate risk syncope patients and recommend to discharge these patients. The time window when to discharge these patients is not defined in the guidelines. In current medical practice low- / intermediate risk syncope patients are either immediately discharged or discharged after 24-hour observation with telemetry (TM). There seems to be an equipoise for both treatment strategies in current medical practice for these low risk syncope patients. A randomized controlled trial to compare discharge after 24 hour observation including TM with immediate discharge has never been done on the Cardiac Emergency Room (CER).
详细描述
The diagnosis of syncope is a worldwide clinical dilemma. Appropriate identification of low risk vs high risk will reduce inappropriate admission for 24-hour observation with TM. The Dutch Geriatrics Society prioritized syncope management on its research agenda. This project is endorsed by the Dutch Societies of Neurology, Cardiology, Geriatrics, and Internal Medicine and results in freely accessible tutorials on an educational website: www.syncopedia.org.
A randomized clinical trial that includes guideline based SA as routine medical care in the setting of a cardiac emergency room, that compares discharge after 24-hour observation with TM (reference treatment strategy) and immediate discharge (investigational treatment strategy) for low- and intermediate syncope patients will provide new insights and improve syncope health care for these patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients that are assessed as low- and intermediate risk syncope, are eligible for inclusion in this trial.
- •The initial syncope evaluation includes:
- •Complete and thorough history taking of the syncope event and past medical history
- •Physical examination including supine and standing BP measurement and
- •12 lead ECG.
排除标准
- •A potential patient who meets any of the following criteria will be excluded from participation in this study:
- •Those aged <18 years
- •Those in whom syncope / transient loss of consciousness co-exist with trauma or other serious condition identified in the CER (massive bleeding, pulmonary embolus) or any high-risk features upon assessment with guideline based SA
- •Those with any other conditions then syncope / transient loss of consciousness for which admission is required (including social indication for admission, etc.)
- •Contraindication for early discharge as the discretion of the responsible physician
- •Those with a learning disability
- •Those presenting with pre-syncope
- •Those who are unwilling to provide informed consent (those will be asked to be enrolled for the SYNCOPE R.I.S.C-registry)
研究组 & 干预措施
discharge
immediate discharge with ambulant HR monitoring (investigational treatment strategy) in low- and intermediate syncope patients in the setting of cardiac emergency room
干预措施: holter (Diagnostic Test)
admission for 24 hours with rhythmobservation
discharge after 24-hour telemetric-observation (reference treatment strategy) in low- and intermediate syncope patients in the setting of cardiac emergency room
干预措施: holter (Diagnostic Test)
结局指标
主要结局
Incidence of Ventricular tachycardia:
时间窗: 24 hour after randomization
a) Any Ventricular Tachycardia (sustained/non sustained) b) Ventricular Fibrillation c) Premature Ventricular Complexes: \>2 doublets or \>2 episodes of 3 seconds duration of bi- or trigemini
Incidence of Supraventricular tachycardia:
时间窗: 24 hour after randomization
a) Any atrial tachycardia (sustained or non-sustained ≥ 3 consecutive complexes) b) Atrio-Ventricular Nodal Re-entry Tachycardia (AVNRT) or Atrioventricular Re-Entry Tachycardia (AVRT) c) Premature Atrial Complex (PAC): \>2 doublets or \>2 episodes of 3 seconds duration of bi- or trigeminy d) Atrial Fibrillation de novo
Incidence of Conduction disorders:
时间窗: 24 hour after randomization
a) Asystole \>3sec (including conversion pauses) b) New first degree AV block with PQ\>300 msec c) Progression first degree AV block with 15% c) 2nd degree AV block Mobitz type I and II d) 3rd degree AV block e) Any SA block
Incidence of Other events
时间窗: 24 hour after randomization
a) Syncope recurrence b) Unexplained fall with injury c) All cause death d) Cardiovascular death
次要结局
- Proportion of additional diagnoses after both treatment strategies(24 hour after randomization)
- Assessment of Quality of life (EQ5D - EuroQuol 5Dimensions)(up to 1 Month)
- Comparison of Syncope related healthcare costs(1 month)
- Hospital utilization and duration of total in-hospital stay for both arms(1 month)
- Assessment of Quality of life (Short Form Health Survey 12)(up to 1 Month)
- Assessment of Quality of life (SyncopeDailyFunctioning)(up to 1 Month)
研究者
Frederik de Lange
principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)