In Hospital 24 Hour Observation of Syncope Patients

Официальное название

Multicenter Randomized Clinical Trial to Assess the Clinical Benefit of 24-hour in Hospital Observation of Syncope Patients Admitted to the Cardiac Emergency Room

Обзор

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).

Подробное описание

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.

Вмешательства

• Диагностический тест holter
  ambulant heart rate monitor (holter) for 24 hour.

Первичные конечные точки

• Incidence of Supraventricular tachycardia: [Срок оценки: 24 hour after randomization]
• Incidence of Ventricular tachycardia: [Срок оценки: 24 hour after randomization]
• Incidence of Conduction disorders: [Срок оценки: 24 hour after randomization]
• Incidence of Other events [Срок оценки: 24 hour after randomization]

Вторичные конечные точки (6)

• Comparison of Syncope related healthcare costs [Срок оценки: 1 month]
• Hospital utilization and duration of total in-hospital stay for both arms [Срок оценки: 1 month]
• Proportion of additional diagnoses after both treatment strategies [Срок оценки: 24 hour after randomization]
• Assessment of Quality of life (EQ5D - EuroQuol 5Dimensions) [Срок оценки: up to 1 Month]
• Assessment of Quality of life (Short Form Health Survey 12) [Срок оценки: up to 1 Month]
• Assessment of Quality of life (SyncopeDailyFunctioning) [Срок оценки: up to 1 Month]

Критерии участия

Критерии включения

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.

Критерии исключения

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Нидерланды · 1 центр

• Amsterdam UMC — Amsterdam

Публикации

• Boel TT, Peeters SYG, van Alem AP, Boogers MJ, Bootsma M, van den Dorpel MA, Firouzi M, Groothuis JGJ, Hemels MEW, Houtgraaf JH, Jansen WPJ, de Jong JSY, Jongenotter M, Kaal ECA, Koomen EM, Langerak SE, Mairuhu G, Mullaart NE, van Rees JB, Samim M, Wierda E, van Zanten S, van Zoelen A, van Barreveld M, Croon PM, Dijkgraaf MGW, Tijssen JGP, De Groot JR, de Lange FJ. Design and rationale of the RISC PMID 42282067

Идентификаторы

NCT: NCT06472375 · NL 81736.018.22

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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