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

Primary Purpose

Acute Myocardial Infarction

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Troponin and Copeptin assay
Sponsored by
Hôpital NOVO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Myocardial Infarction focused on measuring Acute Myocardial Infarction, Troponine, Copeptine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emergency Department (SAMU) Hospital NOVO - Pontoise siteRecruiting
  • Emergency Service - UHCD Hospital NOVO - Pontoise siteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Troponin and Copeptin assay

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
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).
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
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
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

Full Information

First Posted
May 11, 2023
Last Updated
July 5, 2023
Sponsor
Hôpital NOVO
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1. Study Identification

Unique Protocol Identification Number
NCT05902117
Brief Title
Place of Copeptin-troponin Assay in the Elimination Diagnosis of Non-ST+ ACS
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital NOVO

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Acute Myocardial Infarction, Troponine, Copeptine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Troponin and Copeptin assay
Arm Type
Experimental
Arm Description
Collection of an additional blood tube for copeptin determination during blood collection for troponin testing as part of care.
Intervention Type
Diagnostic Test
Intervention Name(s)
Troponin and Copeptin assay
Intervention Description
Collection of an additional blood tube for copeptin determination during blood collection for troponin testing as part of care.
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
At the end of the study, an average of 8 month
Title
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)
Description
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.
Time Frame
At the end of the study, an average of 8 month
Secondary Outcome Measure Information:
Title
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)
Description
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).
Time Frame
At the end of the study, an average of 8 month
Title
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)
Description
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).
Time Frame
At the end of the study, an average of 8 month
Title
Evaluation of the patient's length of stay
Description
Collection of the number of days or hours spent in the emergency service from the time of arrival
Time Frame
At the end of the Study, an average of 8 month
Title
Evaluation of the diagnostic performance of the troponin/ copeptin combination according to the time from onset of pain
Description
The diagnostic performance of the troponin/ copeptin combination is evaluated according to the time between the first pain and blood sampling
Time Frame
At the end of the study, an average of 8 month
Title
Evaluation of pain management in emergency service
Description
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
Time Frame
At the end of the study, an average of 8 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maryline Delattre
Phone
+33 1 30 75 41 31
Email
maryline.delattre@ght-novo.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Veronique Da Costa
Phone
+33 1 30 75 59 60
Email
veronique.dacosta@ght-novo.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Olivier Fancelli
Organizational Affiliation
NOVO Hospital - Pontoise Site
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency Department (SAMU) Hospital NOVO - Pontoise site
City
Pontoise
ZIP/Postal Code
95300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Olivier Fancelli
Phone
+33 1 30 75 40 15
Email
olivier.fancelli@ght-novo.fr
Facility Name
Emergency Service - UHCD Hospital NOVO - Pontoise site
City
Pontoise
ZIP/Postal Code
95300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Patrick Deschamps
Phone
+33 1 30 75 54 02
Email
patrick.deschamps@ght-novo.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
22387754
Citation
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Results Reference
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PubMed Identifier
26547467
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.
Results Reference
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PubMed Identifier
22851671
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.
Results Reference
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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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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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.
Results Reference
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Citation
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.
Results Reference
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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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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Citation
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Results Reference
background
Links:
URL
https://doi.org/10.1007/s13341-013-0370-6
Description
Does This Patient With Chest Pain Have Acute Coronary Syndrome?
URL
https://www.sfmu.org/upload/70_formation/02_eformation/02_congres/Urgences/urgences2012/donnees/pdf/013_charpentier.pdf
Description
Risk stratification of acute coronary syndromes (ST+ and non-ST+)

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

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