NCT05827237

Rule Out of ACS in Primary Care Using a Decision Rule for Chest Pain Including Hs-troponin I POCT

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: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 946 (actual)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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?

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.

Conditions

• Chest Pain
• Myocardial Infarction
• Acute Coronary Syndrome

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Clinical decision rule	Clinical decision rule for acute chest pain, consisting of the Marburg Heart Score (5 questions) combined with a high-sensitive troponin I point of care test

Timeline

• Start date: 2021-08-18
• Primary completion: 2025-02-05
• Completion: 2025-04-23
• First posted: 2023-04-25
• Last updated: 2025-09-10

Locations

1 site across 1 country: Netherlands