Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT05902117 En recrutement IDF

Titre

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 (CopSCA)

Type

Interventional

Pathologie

Infarctus
Infarctus du myocarde

Phase

N/A

Promoteur

Hôpital NOVO (Voir sur ClinicalTrials)

Date de début

juin 2023

Date de fin

mai 2025

Dernière mise à jour

21 septembre 2024

Résumé

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.

Détail

Voir le détail 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. Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
HOPITAL NOVO	FANCELLI	En recrutement IDF	04/07/2024 11:04:57	Contacter

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

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

Critère de non inclusion

- 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

NCT05902117 - 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 (CopSCA)

Informations générales
Etablissements
Critères
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