In Hospital 24 Hour Observation of Syncope Patients
ConditionSyncope
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Patients attending the Cardiac Emergency Room with low- and intermediate risk syncope.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
holter
Diagnostic testambulant heart rate monitor (holter) for 24 hour.
Treatment groups
640 Participants
are divided into 2 treatment groupsGroup A: discharge1 intervention
Group B: admission for 24 hours with rhythmobservation1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
24 hour after randomization2
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
Time frame
24 hour after randomization3
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
Time frame
24 hour after randomization4
Incidence of Other events
a) Syncope recurrence b) Unexplained fall with injury c) All cause death d) Cardiovascular death
Time frame
24 hour after randomizationSecondary outcomes
1
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.
Time frame
1 month2
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.
Time frame
1 month3
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.
Time frame
24 hour after randomization4
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).
Time frame
up to 1 MonthSponsors and contacts
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Source ClinicalTrials.gov