Why the study?
Differentiating ACS from benign conditions is challenging in primary care, leading to high ED referral rates yet occasional missed cases. High-sensitivity troponin point-of-care testing may improve diagnostic safety and efficiency.
Does the HEART-GP strategy improve diagnostic safety and efficiency for ruling out acute coronary syndrome in adults presenting with acute chest pain in primary care?
Does the HEART-GP strategy improve diagnostic safety and efficiency for ruling out acute coronary syndrome in adults presenting with acute chest pain in primary care?
This protocol outlines a prospective multicenter trial to evaluate whether a point-of-care high-sensitivity troponin strategy (HEART-GP) can safely and efficiently rule out acute coronary syndrome in primary care.
Background Acute coronary syndrome (ACS) is a life-threatening condition that must be rapidly identified to prevent morbidity and mortality. Differentiating ACS from benign conditions remains difficult in primary care settings due to non-specific and overlapping symptom profiles, and limited diagnostic resources. Current guidelines promote a low threshold for emergency department (ED) referral, resulting in referral rates of 40–70%. Despite this cautious approach, ACS cases are still missed, sometimes with serious consequences. The arrival of high-sensitivity troponin (hs-troponin) point-of-care testing (POCT) may enable safer, faster, and more efficient diagnosis in primary care settings. Methods and analysis This multicenter prospective diagnostic accuracy trial evaluates the HEART-GP strategy , combining a single fingerstick hs-troponin test with clinical assessment and optional ECG. Adults (≥18 years) presenting with acute chest pain or discomfort to one of four participating Dutch OOH-PC centers are eligible. The primary outcome is the occurrence of major adverse cardiovascular events a composite of death, ACS, or urgent revascularization within six weeks. Diagnostic safety (sensitivity, negative predictive value) and efficiency (ED referral reduction) will be compared against standard care. Secondary analyses will assess the value of sex-specific cut-offs and integration with existing risk scores (HEART, INTERCHEST, Marburg Heart Score). Anticipated results We anticipate that the HEART-GP strategy will demonstrate high diagnostic safety along with marked efficiency gains, with potential for reducing unnecessary ED referrals. If hs-POCT proves reliable, it could be implemented widely to improve the safety and efficiency of acute chest pain evaluation in pre-hospital care. Ethics and dissemination The study was approved by the CCMO (CIV-NL-22-11-041231, 11-03-2022) and the Medical Research Ethics Committee (MREC) of the Amsterdam UMC (NL82428.000.22, 02-03-2023) and registered in the ISRCTN registry ( ISRCTN11954040 ). Results will be disseminated through peer-reviewed journals, academic conferences, and stakeholder engagement to inform future diagnostic pathways in primary care. Strengths and limitations of this study Strengths An innovative, pragmatic strategy for rapid rule-out of ACS High external validity due to prospective, multi-center, real-world OOH-primary care design Identification of the optimal strategy of various risk stratification approaches using hs-troponin testing Blinded, independent adjudication of clinical outcomes Limitations Powered for the composite MACE, but not for the individual components: death, ACS, or urgent coronary revascularization Despite the use of a (delayed) reference standard, complete avoidance of possible verification bias cannot be achieved
No takes yet. Share an insight, caveat, or question.
Melessen et al. (2025) studied this question.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: