A clinical decision rule combining the Marburg Heart Score and hs-cTnI-POCT is being evaluated in a 1,500-patient randomized trial to safely rule out acute coronary syndrome in primary care.
RCT (n=1,500)
2:1 clustered randomized
Yes
Does a clinical decision rule including a high-sensitive cardiac troponin-I point-of-care test reduce hospital referrals and accurately rule out acute coronary syndrome in primary care patients with acute chest pain?
This study protocol outlines a clustered RCT to evaluate whether a clinical decision rule incorporating a high-sensitivity troponin I point-of-care test can safely rule out acute coronary syndrome and reduce emergency department referrals in primary care.
INTRODUCTION: Chest pain is a common reason for consultation in primary care. To rule out acute coronary syndrome (ACS), general practitioners (GP) refer 40%-70% of patients with chest pain to the emergency department (ED). Only 10%-20% of those referred, are diagnosed with ACS. A clinical decision rule, including a high-sensitive cardiac troponin-I point-of-care test (hs-cTnI-POCT), may safely rule out ACS in primary care. Being able to safely rule out ACS at the GP level reduces referrals and thereby alleviates the burden on the ED. Moreover, prompt feedback to the patients may reduce anxiety and stress. METHODS AND ANALYSIS: The POB HELP study is a clustered randomised controlled diagnostic trial investigating the (cost-)effectiveness and diagnostic accuracy of a primary care decision rule for acute chest pain, consisting of the Marburg Heart Score combined with a hs-cTnI-POCT (limit of detection 1.6 ng/L, 99th percentile 23 ng/L, cut-off value between negative and positive used in this study 3.8 ng/L). General practices are 2:1 randomised to the intervention group (clinical decision rule) or control group (regular care). In total 1500 patients with acute chest pain are planned to be included by GPs in three regions in The Netherlands. Primary endpoints are the number of hospital referrals and the diagnostic accuracy of the decision rule 24 hours, 6 weeks and 6 months after inclusion. ETHICS AND DISSEMINATION: The medical ethics committee Leiden-Den Haag-Delft (the Netherlands) has approved this trial. Written informed consent will be obtained from all participating patients. The results of this trial will be disseminated in one main paper and additional papers on secondary endpoints and subgroup analyses. TRIAL REGISTRATION NUMBERS: NL9525 and NCT05827237.
Bulk et al. (2023) conducted an RCT in Acute chest pain (n=1,500). Clinical decision rule (Marburg Heart Score combined with hs-cTnI-POCT) vs. Regular care was evaluated on Number of hospital referrals and diagnostic accuracy of the decision rule at 24 hours, 6 weeks, and 6 months. A clinical decision rule combining the Marburg Heart Score and hs-cTnI-POCT is being evaluated in a 1,500-patient randomized trial to safely rule out acute coronary syndrome in primary care.