Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03913767 |
| Other study ID # |
2017/18AOU/407 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2018 |
| Est. completion date |
April 30, 2020 |
Study information
| Verified date |
April 2021 |
| Source |
Université Catholique de Louvain |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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
1. Acute coronary syndrome
2. Stroke or IAT.
3. Arterial revascularization procedure of peripheral artery.
2. Diabetes
3. 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.
