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Completed

NCT Number: NCT03668587

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Troponin Protocol

Other

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

Primary outcomes

  1. Mortality at 30 day succeeding discharge

    Time frame: 30 days

    After hospital discharge, patients are contacted after 30 day by telephone calls or in written form. Information regarding death are furthermore obtained from the national registry on mortality, the hospital's diagnosis registry, and the family physician's records.

Secondary outcomes

  1. Respect of the 1-hour rule-in and rule-out protocol

    Time frame: 24 hours

    Respect of the 1-hour protocol is assessed by the the respect of the dosage's time frame.

  2. Respect of the 1-hour rule-in and rule-out protocol

    Time frame: 24 hours

    Respect of the 1-hour protocol is assessed by the number of troponin dosage

  3. Respect of the 1-hour rule-in and rule-out protocol

    Time frame: 24 hours

    Respect of the 1-hour protocol is assessed by the patient's discharge.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: ICTUS

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 12, 2018
Registry last updated
Nov 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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