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Feasibility and Security of a Rapid Rule-out and rule-in Troponin Protocol in the Management of NSTEMI in an Emergency Departement

NCT ID: NCT03668587

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1099 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-29

Study Completion Date

2021-09-20

Brief Summary

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Management of NSTEMI in emergency departements represent 10% of the global activity. Since the the last European Society of Cardiology recommendation the use of an 1 hour rule-in and rule-out protocol is recommended combined with high-sensitivity troponin. But studies show 3% of the patients are false negative using this protocol. This study aims at analysing the feasibility of this protocol in an Emergency Departement and the security of this protocol if combined with a pre-troponin probability score.

Detailed Description

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Chest pain is a frequent reason for consultation in emergency departments. Among cardiological causes, quickly diagnosing NSTEMI optimize patient treatment. To do this, the European Society of Cardiology, proposed in 2015 an one hour rule-in rule out troponin dosage based protocol. These recommendations should allow a faster diagnosis of NSTEMI but also a rule-out of patients with a low to moderate clinical probability of coronary heart disease. It could also improve efficiency in emergency departements decreasing the length of stay for patient consulting for acute chest pain allowing use of medical and para medical time for other patients. But the studies on which thoserecommendations are based show up to 3% of false negative, which could lead to a higher mortality rate for those patients even if this issue hasn't been address yet. Furthermore, the tight schedule in which a blood sample need to be withdraw, analyzed and taken knowledge of by the doctor could be an obstacle to the feasibility of such protocol in emergency departments usually overwhelmed with patients. The aim of this monocentric prospective study is to assess how a pre-troponin clinical probability of NSTEMI allowing risk stratification could decrease the false negative rate of this protocol insuring safetiness in its use. The secondary objective is to assess the feasibility of such protocol in an emergency department with high patient flow.

Conditions

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Myocardial Infarction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Troponin Protocol

Feasibility and security of a rapid rule-out and rule-in troponin protocol in the management of NSTEMI in an Emergency Departement.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient with troponin dosage in a suspected NSTEMI.

Exclusion Criteria

* Under 18 years old
* Respiratory rate over 30 per min
* SpO2 under 92%
* Tachycardia over 110 per min
* Bradycardia under 40 per min
* Fever over 38°5C,
* Anemia under 10 g/dL
* Acute intoxication.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nantes University Hospital

Nantes, Loire-Atlantique, France

Site Status

Countries

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France

Other Identifiers

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RC18_0215

Identifier Type: -

Identifier Source: org_study_id