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

Myocardial Infarction Clinical Trial

— ICTUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03668587
• Other study ID #: RC18_0215
• Status: Completed
• Start date: September 29, 2018
• Est. completion date: September 20, 2021

Study information

• Verified date: November 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1099
• Est. completion date: September 20, 2021
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Infarction
• Myocardial Infarction

Intervention

Other:
• Troponin Protocol
Feasibility and security of a rapid rule-out and rule-in troponin protocol in the management of NSTEMI in an Emergency Departement.

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes	Loire-Atlantique

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality at 30 day succeeding discharge	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.	30 days
Secondary	Respect of the 1-hour rule-in and rule-out protocol	Respect of the 1-hour protocol is assessed by the the respect of the dosage's time frame.	24 hours
Secondary	Respect of the 1-hour rule-in and rule-out protocol	Respect of the 1-hour protocol is assessed by the number of troponin dosage	24 hours
Secondary	Respect of the 1-hour rule-in and rule-out protocol	Respect of the 1-hour protocol is assessed by the patient's discharge.	24 hours