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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 (ICTUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03668587
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief 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.

Condition or disease Intervention/treatment
Myocardial Infarction Other: Troponin Protocol

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Feasibility and Security of a Rapid Rule-out and rule-in Troponin Protocol in the Management of NSTEMI in an Emergency Departement.
Actual Study Start Date : September 29, 2018
Estimated Primary Completion Date : November 15, 2020
Estimated Study Completion Date : November 15, 2020

Intervention Details:
  • 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.


Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with troponin dosage in a suspected NSTEMI.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668587


Locations
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France
Nantes University Hospital Recruiting
Nantes, France
Contact: Zeineb Lamoureux, PhD    +33 25 34 82 835    bp-prom-regl@chu-nantes.fr   
Principal Investigator: Julien Segard, MD         
Sponsors and Collaborators
Nantes University Hospital
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03668587    
Other Study ID Numbers: RC18_0215
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Emergencies
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Disease Attributes