In Hospital 24 Hour Observation of Syncope Patients
NCT Number: NCT06472375
Acronym: RISC
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Syncope
Interventions: DIAGNOSTIC_TEST: holter
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 640
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-17
Completion Date: 2026-08-01
Locations: Amsterdam UMC, Amsterdam, 1105 AZ, Netherlands

Summary:
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).

Primary Outcome Measures: Incidence of Supraventricular tachycardia:, 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, 24 hour after randomization|Incidence of Ventricular tachycardia:, 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, 24 hour after randomization|Incidence of Conduction disorders:, 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, 24 hour after randomization|Incidence of Other events, a) Syncope recurrence b) Unexplained fall with injury c) All cause death d) Cardiovascular death, 24 hour after randomization
Secondary Outcome Measures: Comparison of Syncope related healthcare costs, Health care costs will be calculated on the basis of the tariffs set by the schedule of the Dutch National Health Service., 1 month|Hospital utilization and duration of total in-hospital stay for both arms, Hospital utilization of both treatment strategies will be quantified by the duration of the in-hospital stay from the moment of randomization., 1 month|Proportion of additional diagnoses after both treatment strategies, The analysis will be conducted at the major group level, i.e. (1) reflex syncope, (2) orthostatic hypotension, (3) cardiac syncope. Diagnostic yield is defined as the number of patients receiving a diagnosis in the patient chart and is determined at two times during this trial:

1. After performing the guideline based syncope algorithm (before enrollment of the patient) and
2. At 24 hours after completing each treatment strategy., 24 hour after randomization|Assessment of Quality of life (EQ5D - EuroQuol 5Dimensions), The questionnaires include a check-list to assess health care consumption (consultations, admissions), productivity, and QoL measures. 5 dimensions for describing health states. Scores are: no, mild, moderate, severe and extreme or unable to do. (can be scored as 1-5) In the questionnaire is also an Visual Analogue Scale: overall assessment of respondent's health on a scale from 0 (worst health imaginable) to 100 (best health imaginable)., up to 1 Month|Assessment of Quality of life (Short Form Health Survey 12), Questionnaire to asses Quality of Life. Questionnaire contains closed questions with different response options. 'Yes/no', 'never(1)-always(6)' or 'no limitation(1)-severe limitation(3)', up to 1 Month|Assessment of Quality of life (SyncopeDailyFunctioning), Questionnaire to assess qyality of life in daily functioning. Questionnaire contains closed questions with different response options. 'Yes/no' or '1(negative)-8(positive)', up to 1 Month