Myocardial InfarctionICTUSNCT03668587
Feasibility and Security of a Rapid Rule-out and rule-in Troponin Protocol in the Management of NSTEMI in an Emergency Departement
An observational study of Myocardial Infarction, run by Nantes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Troponin Protocol
- How many people
- 1,099 participants
- Where
- 1 siteFrance
- Study dates
- 29 Sep 2018to 20 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with troponin dosage in a suspected NSTEMI.
Who may be able to join
- Patient with troponin dosage in a suspected NSTEMI.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Myocardial Infarction
- Being tested
- Troponin Protocol
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Troponin ProtocolOther
Feasibility and security of a rapid rule-out and rule-in troponin protocol in the management of NSTEMI in an Emergency Departement.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (3)
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.
Measured: 24 hours
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
Measured: 24 hours
Respect of the 1-hour rule-in and rule-out protocol
Respect of the 1-hour protocol is assessed by the patient's discharge.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start29 Sep 2018
- Primary completion20 Aug 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,099 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668587
- Sponsor's protocol ID
- RC18_0215
- Acronym
- ICTUS
- Status last verified
- Nov 2021
- First submitted
- 21 Aug 2018
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Security of a Rapid Rule-out and rule-in Troponin Protocol in the Management of NSTEMI in an Emergency Departement.
- ClinicalTrials.gov ID
- NCT03668587
- Acronym / sponsor ID
- ICTUS / RC18_0215
- Conditions
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,099 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 29 Sep 2018 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with troponin dosage in a suspected NSTEMI.
Key inclusion criteria (1 listed)
- Patient with troponin dosage in a suspected NSTEMI.
Key exclusion criteria (8 listed)
- Under 18 years old
- Respiratory rate over 30 per min
- SpO2 under 92%
- Tachycardia over 110 per min
- Bradycardia under 40 per min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Troponin ProtocolFeasibility and security of a rapid rule-out and rule-in troponin protocol in the management of NSTEMI in an Emergency Departement. | Other | – |
Primary outcome
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.
3 secondary outcomes
Respect of the 1-hour rule-in and rule-out protocol
Time frame: 24 hours
Respect of the 1-hour rule-in and rule-out protocol
Time frame: 24 hours
Respect of the 1-hour rule-in and rule-out protocol
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality at 30 day succeeding discharge (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.