Place of Copeptin-troponin Assay in the Elimination Diagnosis of Non-ST+ ACS

Acute Myocardial Infarction Clinical Trial

— CopSCA  

Official title:

Place of Copeptin-troponin Assay in the Elimination Diagnosis of Non-ST+ ACS in the Management of Pre-hospital and In-hospital Non-traumatic Chest Pain in Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05902117
• Other study ID #: CHRD0821
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2023
• Est. completion date: September 2024

Study information

• Verified date: June 2024
• Source: Hôpital NOVO
• Contact: Maryline Delattre
• Phone: +33 1 30 75 41 31
• Email: maryline.delattre[@]ght-novo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to demonstrate that a combined troponin and copeptin assay can exclude non-ST+ ACS in patients with chest pain less than 6 hours old.

Description:

Chest pain accounts for about 10% of emergency service visits, which represents between 6 and 8 million visits per year in the United States and 15 million in Europe. Depending on the series, coronary etiology is found in 10 to 50% of cases.

Two types of coronary syndrome are distinguished according to the existence of a pathological change in the electrocardiogram.

ST+ acute coronary syndrome is a diagnosis based on the association of chest pain associated with an electrocardiogram change in the form of ST-segment elevation in a systemic territory corresponding to the complete obstruction of an artery of the coronary network.

Non-ST+ coronary syndrome is more difficult to diagnose, as the ECG is not pathological or cannot be interpreted due to the presence of conduction disorders. The diagnosis is currently based on the pathological increase of a specific myocardial biomarker in the blood: troponin.

If the pain is recent (less than six hours) the troponin measured on arrival may be falsely negative, and therefore requires a second measurement 3 hours after the first one (this is the troponin cycle). This second test therefore leads to a longer stay for patients requiring it and contributes to the saturation of the emergency service.

Copeptin is an endogenous stress biomarker that rises immediately during a myocardial infarction and decreases rapidly. Unlike troponin, this marker is not myocardial specific and its level can rise in the blood for many reasons, which is why this marker cannot be used alone in the diagnosis of non-ST+ acute coronary syndrome (non-ST+ ACS or ST- ACS).

The hypothesis would be that the association of a copeptin assay with the initial troponin assay could, if both markers are below pathological thresholds (Troponin < 16ng.dL), eliminate the diagnosis of acute coronary syndrome from the first assays and thus avoid the second troponin assay 3 hours after the first. The patient would reduce the time spent in the emergency and would thus reduce the number of patients in the emergency service.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient =18 years old

• Presenting at the Pontoise emergency department by their own means / ambulance or patients taken care of by the SMUR and referred to the NOVO hospital - Pontoise site

• Chest pain less than 6 hours old

• Chest pain suggestive of ACS (compressive, intense pain, radiating into the arm and neck, mid-thoracic, left thoracic or epigastric location)

• Non-contributory ECG (no ST elevation, presence of bundle branch block)

• Informed and having expressed no objection

• Beneficiary of a social security system (or entitled person)

Non -Inclusion Criteria:

• Sus ST-segment shift on ECG (ACS ST+)

• Intermittent pain/unclear onset time

• Pregnant woman

• Pain in the context of trauma

• Patient under guardianship

• Patient does not speak or understand French

Exclusion Criteria:

• Non-ultrasensitive troponin measurement positive during the 1st SMUR sampling (> 0.08 ng.dL)

• Patient not referred to the NOVO hospital - Pontoise site by the SMUR

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Diagnostic Test:
• Troponin and Copeptin assay
Collection of an additional blood tube for copeptin determination during blood collection for troponin testing as part of care.

Locations

Country	Name	City	State
France	Emergency Department (SAMU) Hospital NOVO - Pontoise site	Pontoise
France	Emergency Service - UHCD Hospital NOVO - Pontoise site	Pontoise

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital NOVO

Country where clinical trial is conducted

France, 

References & Publications (10)

Aarts GWA, van der Wulp K, Camaro C. Pre-hospital point-of-care troponin measurement: a clinical example of its additional value. Neth Heart J. 2020 Oct;28(10):514-519. doi: 10.1007/s12471-020-01434-w. — View Citation

Charpentier S, Beaune S, Joly LM, Khoury A, Duchateau FX, Briot R, Renaud B, Ageron FX; IRU Network. Management of chest pain in the French emergency healthcare system: the prospective observational EPIDOULTHO study. Eur J Emerg Med. 2018 Dec;25(6):404-410. doi: 10.1097/MEJ.0000000000000481. — View Citation

Dawson C, Benger JR, Bayly G. Serial high-sensitivity troponin measurements for the rapid exclusion of acute myocardial infarction in low-risk patients. Emerg Med J. 2013 Jul;30(7):593-4. doi: 10.1136/emermed-2012-201574. Epub 2012 Jul 31. — View Citation

Fanaroff AC, Rymer JA, Goldstein SA, Simel DL, Newby LK. Does This Patient With Chest Pain Have Acute Coronary Syndrome?: The Rational Clinical Examination Systematic Review. JAMA. 2015 Nov 10;314(18):1955-65. doi: 10.1001/jama.2015.12735. — View Citation

Hamm CW, Bassand JP, Agewall S, Bax J, Boersma E, Bueno H, Caso P, Dudek D, Gielen S, Huber K, Ohman M, Petrie MC, Sonntag F, Uva MS, Storey RF, Wijns W, Zahger D; ESC Committee for Practice Guidelines. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: The Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2011 Dec;32(23):2999-3054. doi: 10.1093/eurheartj/ehr236. Epub 2011 Aug 26. No abstract available. — View Citation

Khan SQ, Dhillon OS, O'Brien RJ, Struck J, Quinn PA, Morgenthaler NG, Squire IB, Davies JE, Bergmann A, Ng LL. C-terminal provasopressin (copeptin) as a novel and prognostic marker in acute myocardial infarction: Leicester Acute Myocardial Infarction Peptide (LAMP) study. Circulation. 2007 Apr 24;115(16):2103-10. doi: 10.1161/CIRCULATIONAHA.106.685503. Epub 2007 Apr 9. — View Citation

Kim KS, Suh GJ, Song SH, Jung YS, Kim T, Shin SM, Kang MW, Lee MS. Copeptin with high-sensitivity troponin at presentation is not inferior to serial troponin measurements for ruling out acute myocardial infarction. Clin Exp Emerg Med. 2020 Mar;7(1):35-42. doi: 10.15441/ceem.19.013. Epub 2020 Mar 31. — View Citation

Kohn MA, Kwan E, Gupta M, Tabas JA. Prevalence of acute myocardial infarction and other serious diagnoses in patients presenting to an urban emergency department with chest pain. J Emerg Med. 2005 Nov;29(4):383-90. doi: 10.1016/j.jemermed.2005.04.010. — View Citation

Mockel M, Searle J, Muller R, Slagman A, Storchmann H, Oestereich P, Wyrwich W, Ale-Abaei A, Vollert JO, Koch M, Somasundaram R. Chief complaints in medical emergencies: do they relate to underlying disease and outcome? The Charite Emergency Medicine Study (CHARITEM). Eur J Emerg Med. 2013 Apr;20(2):103-8. doi: 10.1097/MEJ.0b013e328351e609. — View Citation

Szarpak L, Lapinski M, Gasecka A, Pruc M, Drela WL, Koda M, Denegri A, Peacock FW, Jaguszewski MJ, Filipiak KJ. Performance of Copeptin for Early Diagnosis of Acute Coronary Syndromes: A Systematic Review and Meta-Analysis of 14,139 Patients. J Cardiovasc Dev Dis. 2021 Dec 27;9(1):6. doi: 10.3390/jcdd9010006. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstrate that a combined troponin and copeptin assay can exclude non-ST+ ACS in patients with chest pain less than 6 hours old (sensitivity/specificity)	Comparison of copeptin and troponin assays in the final diagnosis of non-ST+ ACS based on emergency medical records by calculation the sensitivity/specificity of the troponin - copeptin pair.	At the end of the study, an average of 8 month
Primary	Demonstrate that a combined troponin and copeptin assay can exclude non-ST+ ACS in patients with chest pain less than 6 hours old (negative predictive value)	Comparison of copeptin and troponin assays in the final diagnosis of non-ST+ ACS based on emergency medical records by calculation of the negative predictive value of the troponin - copeptin pair.	At the end of the study, an average of 8 month
Secondary	Evaluation of the diagnostic performance (sensitivity/specificity) of the troponin/ copeptin association according to cardiovascular risk factors (age, smoking, hypertension, history of cardiac ischemia, overweight, heredity)	Evaluation of the diagnostic performance (sensitivity/specificity) of the troponin - copeptin pair for each subgroup of cardiovascular risk factors (age / smoking / hypertension / history of cardiac ischemia / overweight and heredity).	At the end of the study, an average of 8 month
Secondary	Evaluation of the diagnostic performance (negative predictive value) of the troponin/ copeptin association according to cardiovascular risk factors (age, smoking, hypertension, history of cardiac ischemia, overweight, heredity)	Evaluation of the diagnostic performance (negative predictive value) of the troponin - copeptin pair for each subgroup of cardiovascular risk factors (age / smoking / hypertension / history of cardiac ischemia / overweight and heredity).	At the end of the study, an average of 8 month
Secondary	Evaluation of the patient's length of stay	Collection of the number of days or hours spent in the emergency service from the time of arrival	At the end of the Study, an average of 8 month
Secondary	Evaluation of the diagnostic performance of the troponin/ copeptin combination according to the time from onset of pain	The diagnostic performance of the troponin/ copeptin combination is evaluated according to the time between the first pain and blood sampling	At the end of the study, an average of 8 month
Secondary	Evaluation of pain management in emergency service	Assessment of the evolution of pain via the numerical scale (EN), rated from 0 to 10, between arrival in the emergency room and reassessment at 3 hours	At the end of the study, an average of 8 month

External Links

•   Does This Patient With Chest Pain Have Acute Coronary Syndrome?
•   Risk stratification of acute coronary syndromes (ST+ and non-ST+)