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RCT to assess In hospital 24 hour observation with telemetry of Syncope patients admitted to the Cardiac Emergency Room

RCT to assess In hospital 24 hour observation with telemetry of Syncope patients admitted to the Cardiac Emergency Room - SYNCOPE R.I.S.C. trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51650
Enrollment
580
Registered
2022-07-24
Start date
2024-11-27
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syncope T-LOC Fainting

Interventions

The immediate discharge of ESC guideline based low- and intermediate-risk stratified syncope patients on the (cardiac) emergency department compared to 24-hour in-hospital rhythm observation

Sponsors

Universiteit van Amsterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All patients with low risk- and intermediar risk syncope presented on the Cardiac Emergency Care, will be eligible for the study.

Exclusion criteria

Exclusion criteria: (1) Those aged <18 years (2) Those in whom syncope / transient loss of consciousness co-exisits 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 (see appendix 2) (3) Those with any other conditions then syncope / transient loss of  consciousness for which admission is required (including social indication for  admission, etc.) (4) Contraindication for early discharge at the discretion of the responsible  physician (5) Those with a learning disability (6) Those presenting with pre-syncope (7) Those who are unwilling to provide informed consent (those will be asked to  be enrolled for the SYNCOPE R.I.S.C - registry)

Design outcomes

Primary

MeasureTime frame
Primary: (non-)fatal serious adverse events in both arms (non-inferiority)

Secondary

MeasureTime frame
Secondary: healthcare costs and hospital utilization (superiority), proportion of additional diagnoses in both treatment arms after 24 hrs and 7 days of ambulant holter monitoring and QoL during 1 month after presentation on ED.

Countries

Netherlands

Contacts

Public ContactT.T. Boel

Universiteit van Amsterdam

risctrial@amsterdamumc.nl0642819194

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 27, 2026