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Chest PainCECIDOCNCT03913767

Chest Pain Triage at ED

An observational study of Chest Pain, run by Université Catholique de Louvain at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

CECIDOC is a prospective, monocentric and observational study comparing the diagnostic performance of ECG-base triage to a combination of ECG and cardiovascular risk factors for chest pain triage at ED. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chest Pain
How many people
500 participants
Where
1 siteBelgium
Study dates
1 Nov 2018to 30 Apr 2020
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: All consecutive patients above 18 years of age, presenting at ED with acute non-traumatic chest pain as main complaint will be systematically included in the study.

Who may be able to join

  • non traumatic chest pain at ED

Who cannot join

  • under 18y

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Cliniques St Luc

    Brussels, 1200

Other trials in Belgium

About this study

Official title: Combination of ECG and Cardiovascular Risk Factors Could Increase Diagnostic Performance Of Chest Pain Triage at ED

CECIDOC is a prospective, monocentric and observational study comparing the diagnostic performance of ECG-base triage to a combination of ECG and cardiovascular risk factors for chest pain triage at ED.

Read the detailed description

Background

Acute chest pain triage in the Emergency Department (ED) may prove challenging, since similar symptoms can reveal both mild or life-threatening disorders, and the clinical presentation itself is known not to be reliable for evaluating the risk of acute coronary syndrome (ACS) .

The first priority in patients with suspected ACS is to identify those with ST-elevation myocardial infarction (STEMI), since these patients require urgent reperfusion therapy. Both European and American cardiology guidelines recommend implementation of a 12-lead electrocardiogram (ECG) within 10 min of arrival in the ED.

In contrast, in the absence of electrocardiographic changes consistent with ischemia, the ACS rate is low (1-8% depending on the number of risk factors) , and ACS are associated with lower in-hospital mortality.

Emergency Department (ED) triage systems for acute chest pain are either based on clinical features or on a 12-lead ECG. A recent study showed the systems having a similar diagnostic performance but different characteristics since clinical-based triage had a higher sensitivity and ECG-based triage had a higher specificity. The lack of sensitivity of ECG based triage was explained by the fact that patients with a normal or non-ischemic ECG were assigned to a low-acuity triage score, defined as inadequate (false negative) for ACS patients. Conversely, the lack of specificity of clinical based triage was due to a large number of patients with benign pathology assigned to a high-acuity triage score to perform a 12-lead ECG within the 10 minutes after the first medical contact as required.

The investigators therefore hypothesized that combination of 12-lead ECG and cardiovascular risk factor could increase the sensitivity of ECG based triage for chest pain patients with a normal or non-ischemic ECG.

Methods

Selection of participants

All consecutive patients above 18 years of age, presenting at ED with acute non-traumatic chest pain as main complaint will be systematically included in the study.

Study design

The investigators plan a prospective, single-center, observational study in a teaching hospital in Brussels, Belgium.

Triage of chest pain patients will be performed using the "French Emergency Nurses Classification version 2" (FRENCH) triage system, which is currently used in our ED. FRENCH score is a 5-levels triage system classifying patients from category 1 corresponding to the "immediately life-threatening condition" to category 5 corresponding to the "less or non-urgent situations". Maximum authorized waiting period before first medical assessment according to severity category are respectively: immediate response, 20 minutes, 60 minutes, 120 minutes and undefined. Initial triage of chest pain patients is based on vital signs, than if normal patients with a normal or unmodified ECG are sorted into category 3, those with an abnormal ECG without evidence of ischemia are classified into category 2, while those with ECG showing signs of ischemia (ST elevation, ST depression, new onset of a left bundle branch block, or T-wave inversions) are classified into category 1. Patients with lateral chest pain of a probable musculoskeletal nature are sorted into category 4 without performing an ECG.

The FRENCH triage (ECG-based triage) will be compared to a modified FRENCH triage system (ECGScore- based triage) upgrading high-risk patients with a normal ECG from category 3 to category 2. The investigators defined high-risk patients as patients having a Systemic Coronary Risk Estimation (SCORE) above 10 % according to the 2016 European Guidelines on cardiovascular disease prevention in clinical practice. To facilitate calculation of the SCORE at triage, the investigators defined one major or four minor criteria required to upgrade the patients.

The major criteria are:

  1. History of Cardio-vascular disease
  2. Acute coronary syndrome
  3. Stroke or IAT.
  4. Arterial revascularization procedure of peripheral artery.
  5. Diabetes
  6. End-stage renal disease or dialysis

The minor criteria are:

  1. Man
  2. Above 60 years of age
  3. Hypertension
  4. Smoker
  5. Dyslipidemia

The above criteria will be collected by the triage nurse using a computerized form designed for the study. On this basis, the computer will additionally sort the patients using the modified triage scale, with blinded result avoiding bias in the initial nurse triage. This modified triage will therefore not be taken into account and management of the patients will not be modified.

Medical data will also be collected by physicians using a dedicated computerized form, particularly cardiovascular risks factors and complications occurring during the ED stay (arrhythmia, heart failure, shock).

The final diagnosis will be determined at the end of a 30-day follow-up, by either reviewing patient's files or a phone call to patients or relatives. ECG interpretation and diagnosis of acute myocardial infarction will be based on the universal definition of myocardial infarction. Pulmonary embolism and aortic dissection will be substantiated by computed tomography (CT), chest infection by relevant positive biomarkers and a chest X-ray, gastroesophageal reflux by gastroscopy or positive therapeutic test with a proton pump inhibitor, and abdominal pathology by biology, imaging, or both. Musculoskeletal pain will be diagnosed if all of the above-mentioned investigations are normal, and movement and palpation enhanced superficial pain. Finally, patients with a normal physical examination, ECG, chest X-ray, and blood tests who did not report any event during the 30-day follow-up, and who therefore have no definite cause for their chest pain, will be sorted into a dedicated group called 'unclear diagnosis'.

The local hospital ethics committee approved the study protocol (CEHF 2017/18AOU/407), and patients will provide their written informed consent to participate in this study.

Statistical methods

To evaluate triage system's diagnostic performance, the investigators will compare the triage score of patients with ACS (final diagnosis of STEMI, non-ST-elevation myocardial infarction [NSTEMI] or unstable angina [UA]) to a control group made up of patients with chest pain from mild severity diseases (including digestive diseases, chronic obstructive pulmonary disease (COPD) exacerbation, musculoskeletal chest pain, and all unclear diagnoses without any medical event in the follow-up period). Patients with other severe diseases, abnormal heart rate, abnormal blood pressure, respiratory distress, or hypoxemia will be excluded from the control group having a triage score driven by these conditions rather than by the ECG.

Since for ACS most of the arrhythmic events occur within 12 h of symptom onset and ACS patients should be monitored, the investigators defined for ACS a triage Score of 1 or 2 (high-acuity triage score) as adequate (true positive), and a triage Score of 3, 4, or 5 (low-acuity triage score) as inadequate (false negative). Conversely, for the control group with mild severity diseases, the investigators defined a triage Score of 1 or 2 (high-acuity triage score) as inadequate (false positive), and a triage Score of 3, 4 or 5 (low-acuity triage score) as adequate (true negative). Receiver operating characteristic (ROC) curves will be generated to assess each triage system's accuracy in classifying a patient in ACS versus control group.

Capability of triage nurses to collect cardiovascular risk factors will be assessed comparing data collected at triage to these collected by the physician in the medical computerized file.

Sample Size

Based on a previous study, FRENCH score AUC under the ROC curve was 0.69. The investigators hypothesized a corelation of 0.9 between the two tests. To show a difference of 0.06 between the AUC of the tests with a power of 0.8 (alpha 0.05) we calculated a sampled size of 233 patients. Given the uncertainty of the correlation, we planned to enrol 500 patients.

Conditions
Chest Pain
Keywords
Chest pain, Acute coronary syndrom, ED triage
Medical subject headings
Chest Pain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of the diagnostic performance of the two triage systems.

    Diagnostic performance of ECG and combination of ECG and cardiovascular risk factor to triage chest pain patient at ED will be compared by calculating the Area Under the ROC Curves of the two triage systems.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2019
  2. Study start1 Nov 2018
  3. Primary completion31 Mar 2020
  4. Study completion30 Apr 2020

Resources

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
Cohort
Time perspective
Prospective
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03913767
Sponsor's protocol ID
2017/18AOU/407
Acronym
CECIDOC
Status last verified
Apr 2021
First submitted
4 Apr 2019
Last updated
28 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Casarin C, Pirot AS, Gregoire C, Van Der Haert L, Vanden Berghe P, Castanares-Zapatero D, Dechamps M. Improving the performance of a triage scale for chest pain patients admitted to emergency departments: combining cardiovascular risk factors and electrocardiogram. BMC Emerg Med. 2022 Jul 4;22(1):118. doi: 10.1186/s12873-022-00680-y.

    PubMed 35788195

Questions about this trial

What is this clinical trial studying?

An observational study of Chest Pain, run by Université Catholique de Louvain at 1 site in Belgium.

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 1 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 28 Apr 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 Belgium. 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?

Comparison of the diagnostic performance of the two triage systems. (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03913767, which also lists 1 linked publication.

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 28 Apr 2021.

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