NCT03668587

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,099

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

September 29, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2021

Completed
Last Updated

November 19, 2021

Status Verified

November 1, 2021

Enrollment Period

2.9 years

First QC Date

August 21, 2018

Last Update Submit

November 18, 2021

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

    24 hours

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

    24 hours

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

    24 hours

Interventions

Troponin ProtocolOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with troponin dosage in a suspected NSTEMI.

You may qualify if:

  • Patient with troponin dosage in a suspected NSTEMI.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2018

First Posted

September 12, 2018

Study Start

September 29, 2018

Primary Completion

August 20, 2021

Study Completion

September 20, 2021

Last Updated

November 19, 2021

Record last verified: 2021-11

Locations

FR(1)