Efficacy of HEAR and HEART score to rule out major adverse cardiac events in patients presenting to the emergency department with chest pain: study protocol of the eCARE stepped-wedge randomised control trial
Introduction Current guidelines for patients presenting to the emergency department (ED) with chest pain without ST-segment elevation myocardial infarction (STEMI) on ECG are based on serial troponin measurements. A clinical tool able to identify very low-risk patients who could forgo a troponin tes...
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BMJ Publishing Group
2022-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/12/e066953.full |
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| author | Sandrine Charpentier Pierre-Marie Roy Delphine Douillet Jeremie Riou Fabrice Prunier Thomas Moumneh Andrea Penaloza |
| author_facet | Sandrine Charpentier Pierre-Marie Roy Delphine Douillet Jeremie Riou Fabrice Prunier Thomas Moumneh Andrea Penaloza |
| author_sort | Sandrine Charpentier |
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| description | Introduction Current guidelines for patients presenting to the emergency department (ED) with chest pain without ST-segment elevation myocardial infarction (STEMI) on ECG are based on serial troponin measurements. A clinical tool able to identify very low-risk patients who could forgo a troponin test and low-risk patients requiring only one troponin measurement would be of great interest. To do so, the HEAR and HEART score, standing for history, ECG, age, risk factors±troponin were prospectively assessed, but not combined and implemented in clinical practice. The objective of the eCARE study is to assess the impact of implementing a diagnostic strategy based on a HEAR score <2 or a HEART score <4 (HEAR-T strategy) to rule out non-STEMI without or with a single troponin measurement in patients presenting to the ED with chest pain without obvious diagnosis after physical examination and an ECG.Methods and analysis Stepped-wedge cluster-randomised control trial in 10 EDs. Patients with non-traumatic chest pain and no formal diagnosis were included and followed for 30 days. In the interventional phase, the doctor will be asked not to perform a troponin test to look for an acute coronary if the HEAR score is <2 and not to perform an additional troponin test if the HEAR score is ≥2 and HEART score is <4. The main endpoint is the non-inferiority of the rates of major adverse cardiac events occurring between a patient’s discharge and the 30-day follow-up against current recommended guidelines.Ethics and dissemination The study was approved by an institutional review board for all participating centres. If successful, the eCARE study will cover a gap in the evidence, proving that it is safe and efficient to rule out the hypothesis of an acute myocardial infarction in some selected very low-risk patients or based on a single troponin measurement in some low-risk patients.Trial registration number NCT04157790. |
| format | Article |
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| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-12-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-03801d849aa94f468093c3fbffa72bb82025-08-20T03:11:25ZengBMJ Publishing GroupBMJ Open2044-60552022-12-01121210.1136/bmjopen-2022-066953Efficacy of HEAR and HEART score to rule out major adverse cardiac events in patients presenting to the emergency department with chest pain: study protocol of the eCARE stepped-wedge randomised control trialSandrine Charpentier0Pierre-Marie Roy1Delphine Douillet2Jeremie Riou3Fabrice Prunier4Thomas Moumneh5Andrea Penaloza62 Faculté de médecine, Paul Sabatier University, Toulouse, FranceInstitut MitoVasc, UMR CNRS 6215 INSERM 1083, Angers, FranceInstitut MitoVasc, UMR CNRS 6215 INSERM 1083, Université d`Angers, Angers, France3 Micro et Nano médecines Translationnelles, MINT, UNIV Angers, UMR INSERM 1066, UMR CNRS 6021, CHU Angers, Angers, FranceCardiologie, Université Angers, UPRES EA3860, Laboratoire Cardioprotection, Remodelage et Thrombose, CHU Angers, Angers, France18 Emergency Department, CHU Angers, Angers, France19 Emergency, Cliniques universitaires Saint-Luc, Bruxelles, BelgiumIntroduction Current guidelines for patients presenting to the emergency department (ED) with chest pain without ST-segment elevation myocardial infarction (STEMI) on ECG are based on serial troponin measurements. A clinical tool able to identify very low-risk patients who could forgo a troponin test and low-risk patients requiring only one troponin measurement would be of great interest. To do so, the HEAR and HEART score, standing for history, ECG, age, risk factors±troponin were prospectively assessed, but not combined and implemented in clinical practice. The objective of the eCARE study is to assess the impact of implementing a diagnostic strategy based on a HEAR score <2 or a HEART score <4 (HEAR-T strategy) to rule out non-STEMI without or with a single troponin measurement in patients presenting to the ED with chest pain without obvious diagnosis after physical examination and an ECG.Methods and analysis Stepped-wedge cluster-randomised control trial in 10 EDs. Patients with non-traumatic chest pain and no formal diagnosis were included and followed for 30 days. In the interventional phase, the doctor will be asked not to perform a troponin test to look for an acute coronary if the HEAR score is <2 and not to perform an additional troponin test if the HEAR score is ≥2 and HEART score is <4. The main endpoint is the non-inferiority of the rates of major adverse cardiac events occurring between a patient’s discharge and the 30-day follow-up against current recommended guidelines.Ethics and dissemination The study was approved by an institutional review board for all participating centres. If successful, the eCARE study will cover a gap in the evidence, proving that it is safe and efficient to rule out the hypothesis of an acute myocardial infarction in some selected very low-risk patients or based on a single troponin measurement in some low-risk patients.Trial registration number NCT04157790.https://bmjopen.bmj.com/content/12/12/e066953.full |
| spellingShingle | Sandrine Charpentier Pierre-Marie Roy Delphine Douillet Jeremie Riou Fabrice Prunier Thomas Moumneh Andrea Penaloza Efficacy of HEAR and HEART score to rule out major adverse cardiac events in patients presenting to the emergency department with chest pain: study protocol of the eCARE stepped-wedge randomised control trial BMJ Open |
| title | Efficacy of HEAR and HEART score to rule out major adverse cardiac events in patients presenting to the emergency department with chest pain: study protocol of the eCARE stepped-wedge randomised control trial |
| title_full | Efficacy of HEAR and HEART score to rule out major adverse cardiac events in patients presenting to the emergency department with chest pain: study protocol of the eCARE stepped-wedge randomised control trial |
| title_fullStr | Efficacy of HEAR and HEART score to rule out major adverse cardiac events in patients presenting to the emergency department with chest pain: study protocol of the eCARE stepped-wedge randomised control trial |
| title_full_unstemmed | Efficacy of HEAR and HEART score to rule out major adverse cardiac events in patients presenting to the emergency department with chest pain: study protocol of the eCARE stepped-wedge randomised control trial |
| title_short | Efficacy of HEAR and HEART score to rule out major adverse cardiac events in patients presenting to the emergency department with chest pain: study protocol of the eCARE stepped-wedge randomised control trial |
| title_sort | efficacy of hear and heart score to rule out major adverse cardiac events in patients presenting to the emergency department with chest pain study protocol of the ecare stepped wedge randomised control trial |
| url | https://bmjopen.bmj.com/content/12/12/e066953.full |
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