Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05827237
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2023-03-21
Brief Title:
Rule Out of ACS in Primary Care Using a Decision Rule for Chest Pain Including Hs-troponin I POCT
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
Primary Care Decision Rule for Chest Pain Using the Marburg Heart Score and Hs-troponin I Point of Care Test to Rule Out Acute Coronary Syndrome
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
POB HELP
Brief Summary:
The goal of this clustered diagnostic randomized controlled trial is to study a clinical decision rule including a high-sensitive troponin I point of care test in patients with chest pain in primary care
The main questions it aims to answer are
1 Can unnecessary referrals to secondary care be reduced by the use of a clinical deci-sion rule in patients with new onset non-traumatic chest pain in primary care Compared to current daily practice
2 What is the accuracy sensitivity negative prediction value of the clinical decision rule for excluding ACS and MACE at 6 weeks and 6 months
The main questions it aims to answer are
1 Can unnecessary referrals to secondary care be reduced by the use of a clinical deci-sion rule in patients with new onset non-traumatic chest pain in primary care Compared to current daily practice
2 What is the accuracy sensitivity negative prediction value of the clinical decision rule for excluding ACS and MACE at 6 weeks and 6 months
Detailed Description:
This clustered diagnostic randomized controlled trial will included patients with acute chest pain consulting their general practitioner Practices in the intervention group will use a clinical decision rule consisting of the Marburg Heart Score and a high-sensitive troponin I point of care test to exclude acute coronary syndrome ACS and decide upon referral Practices in the control group will apply usual care following local guidelines
An independent endpoint committee consisting of a cardiologist and general practitioner will adjudicate the final diagnosis Primary endpoints are ACS and Major Adverse Cardiac Events A delayed reference standard of 6 months will be used
For high sensitive troponin I measurement the Siemens Atellica VTLi immunoassay analyser is used
An independent endpoint committee consisting of a cardiologist and general practitioner will adjudicate the final diagnosis Primary endpoints are ACS and Major Adverse Cardiac Events A delayed reference standard of 6 months will be used
For high sensitive troponin I measurement the Siemens Atellica VTLi immunoassay analyser is used
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