Ignite Creation Date:
2024-07-17 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06472375
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-02-13
Brief Title:
In Hospital 24 Hour Observation of Syncope Patients
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Multicenter Randomized Clinical Trial to Assess the Clinical Benefit of 24-hour in Hospital Observation of Syncope Patients Admitted to the Cardiac Emergency Room
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RISC
Brief 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
Detailed Description:
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 wwwsyncopediaorg
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None