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

NCT05902117 | Completed

• 1 other identifier: CHRD0821
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Acute Myocardial Infarction

Keywords

Acute Myocardial Infarction; Troponine; Copeptine

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• 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)

  At the end of the study, an average of 8 month

• 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)

  At the end of the study, an average of 8 month

• Evaluation of the patient's length of stay

  At the end of the Study, an average of 8 month

• Evaluation of the diagnostic performance of the troponin/ copeptin combination according to the time from onset of pain

  At the end of the study, an average of 8 month

• Evaluation of pain management in emergency service

  At the end of the study, an average of 8 month

Study Arms (1)

Troponin and Copeptin assay

EXPERIMENTAL

Collection of an additional blood tube for copeptin determination during blood collection for troponin testing as part of care.

Diagnostic Test: Troponin and Copeptin assay

Interventions

Troponin and Copeptin assay DIAGNOSTIC_TEST

Collection of an additional blood tube for copeptin determination during blood collection for troponin testing as part of care.

Troponin and Copeptin assay

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital NOVO: lead

Study Sites (2)

Emergency Department (SAMU) Hospital NOVO - Pontoise site

Pontoise, 95300, France

Location

Emergency Service - UHCD Hospital NOVO - Pontoise site

Pontoise, 95300, France

Location

Related Publications (10)

• 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.

  PMID: 22387754 BACKGROUND

• 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.

  PMID: 26547467 BACKGROUND

• 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.

  PMID: 22851671 BACKGROUND

• 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.

  PMID: 17420344 BACKGROUND

• 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.

  PMID: 32252132 BACKGROUND

• 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.

  PMID: 35050216 BACKGROUND

• 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.

  PMID: 32514934 BACKGROUND

• 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.

  PMID: 16243193 BACKGROUND

• 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.

  PMID: 28723703 BACKGROUND

• 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.

  PMID: 21873419 BACKGROUND

Related Links

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

Study Officials

• Dr Olivier Fancelli

  NOVO Hospital - Pontoise Site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: June 13, 2023
• Study Start: June 28, 2023
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: March 18, 2025

Record last verified: 2024-06

Locations

FR (2)