The HEART-GP strategy for ruling out acute coronary syndrome in out-of-hours primary care: a diagnostic accuracy trial protocol

HEART-GP策略在非工作时间基层医疗中排除急性冠脉综合征:一项诊断准确性试验方案

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Abstract

BACKGROUND: Acute coronary syndrome (ACS) is a life-threatening condition that requires rapid identification to prevent morbidity and mortality. Differentiating ACS from benign conditions remains difficult in out-of-hours primary care (OOH-PC) settings due to non-specific and overlapping symptom profiles, and limited diagnostic resources. Current guidelines promote a low threshold for emergency department (ED) referral. Despite this cautious approach, ACS cases are still missed. The arrival of high-sensitivity troponin (hs-troponin) point-of-care testing (POCT) may enable safer, faster, and more efficient diagnosis. 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. ANTICIPATED RESULTS: We anticipate that the HEART-GP strategy will demonstrate improved diagnostic safety along with efficiency gains in OOH-PC. Our straightforward rapid rule-out strategy holds promise to be widely implemented in primary care settings to advance the evaluation of acute chest pain. ETHICS: The study was approved by the Medical Research Ethics Committee of the Amsterdam UMC (NL82428.000.22, 02-03-2023) and registered in the ISRCTN-registry (ISRCTN11954040 https://doi.org/10.1186/ISRCTN11954040).

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