Clinical trial NCT03111862: Safety of Accelerated Rule-out Protocols in Patients Admitted With Chest Pain to a Crowded Chest Pain Unit (CPU)
Official title: Observational Study on the Safety of Accelerated Rule-out Protocols in Patients Admitted With Chest Pain to a Crowded CPU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
NSTEMI - Non-ST Segment Elevation MI
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 3567
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients presenting to CPU with suspected ACS based on chest pain or chest pain equivalent symptoms

Brief summary: The aim of this observational study registry is to assess the safety of a Non-ST-elevation myocardial infarction (STEMI) rapid rule-out strategy as proposed by European Guidelines in patients presenting with suspected acute coronary syndrome to the emergency department.

Detailed description: Design: mono-center observational study in a University chest pain unit

Duration: 12 months recruitment period starting June 2016 with end of recruitment July 2017. In the first 6 months assessment of situation, January 2017 introduction of fast protocols, i.e. 0/1 h as standard, observation of trend changes, utilization rates, safety from January 1st until July 2017. Another 90 days follow-up after last patient in.

Background: Several rule-out protocols recommended by 2015 European Society of Cardiology (ESC) guidelines, evidence supported by prospectively validated studies. However, no real life experience with ultilization rates and safety.

Particularly overcrowded emergency departments (EDs) or CPUs are likely to benefit most from fast rule-out protocols in order to discharge a substantial proportion of low risk patients.

Study group: consecutive patients presenting to CPU with suspected acute coronary syndrome (ACS) based on chest pain or chest pain equivalent symptoms

Inclusion criteria: eligible to consent, \> 18 years

Exclusion criteria: rule-in, observational zone, chronic hemodialysis, no consent, atrial tachyarrhythmias with chest pain or equivalent.

Data collection on: demographics, rule-out diagnostic protocol (instant cardiac troponin+Copeptin, instant at Limit of Detection, 0-1h, 0-3 h, 0-6 hour, other; time of second sample from admission; turnaround time for first and consecutive sample(s); rates of echo, computed tomography (CT) coronary or CT pulmonary artery, CT chest or CT triple rule-out, chest X-ray, stress test performed or recommended within 3 working days; length of stay in ED, length of stay in hospital including initial referral; rates of admission, discharge or referral; rates of in-hospital percutaneous coronary Intervention (PCI) or coronary artery Bypass graft (CABG), coronary angiography findings based on a definition of obstructive coronary artery disease (CAD) ≥ 50% stenosis.

Specific data: Number of patients seeking attendance in CPU per day (crowding index), GRACE score, secondary risk factors present or not (leftventricular ejection fraction (LVEF) \< 40%, glomerular filtration rate\< 60 ml/min, Diabetes mellitus, previous myocardial infarction (MI), previous CABG, prior PCI, ST segment depression). Rule-out protocols are stratified by hour ± 30 min, i.e. 0-1 h (±30 min), 0-2 h (±30 min), 0-3 h (±30 min) etc.

Clinical work-up results: stress test before discharge positive or negative, transthoracic echocardiography: wall motion abnormalities, LVEF, valvular heart disease, structural heart disease, Endpoint(s): primary safety endpoint defined as survival free of all-cause death, secondary endpoints: survival free of death or MI, survival free of death/MI/re-hospitalisation for ACS, survival free of death/MI/rehospitalisation for non-elective revascularization

Follow-up: 30 days and 3 months follow-up (FU) for all-cause death, MI, re-hospitalisation for ACS, re-hospitalisation for non-elective PCI or CABG Statistical plan: no sample size calculation, Student´s T-test, ANOVA, Kaplan Meier survival, Cox proportional regression analysis

Milestones: Start immediately after contract for a recruitment period 9/16 - 9/17 (12 months) plus 3 months FU after last patient in. Additional 3 months for completion of files and FU data.

Eligibility criteria: Inclusion Criteria:

* eligible to consent
* \>18 years

Exclusion Criteria:

* NSTEMI rule-in
* hs-TnT in observational zone
* chronic hemodialysis
* no consent
* atrial tachyarrhythmias with chest pain or equivalent

Primary outcomes:
measure: All-cause death
timeFrame: 30 days and 3 months
Secondary outcomes:
measure: Acute Myocardial Infarction
timeFrame: 30 days and 3 months
measure: Rehospitalization for Acute Coronary Syndrome
timeFrame: 30 days and 3 months
measure: Rehospitalization for nonelective percutaneous coronary intervention
timeFrame: 30 days and 3 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Universtity Hospital
Study officials:
affiliation: University Hospital Heidelberg
name: Moritz Biener, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stoyanov KM, Biener M, Hund H, Mueller-Hennessen M, Vafaie M, Katus HA, Giannitsis E. Effects of crowding in the emergency department on the diagnosis and management of suspected acute coronary syndrome using rapid algorithms: an observational study. BMJ Open. 2020 Oct 8;10(10):e041757. doi: 10.1136/bmjopen-2020-041757.
citation: Giannitsis E, Biener M, Hund H, Mueller-Hennessen M, Vafaie M, Gandowitz J, Riedle C, Lohr J, Katus HA, Stoyanov KM. Management and outcomes of patients with unstable angina with undetectable, normal, or intermediate hsTnT levels. Clin Res Cardiol. 2020 Apr;109(4):476-487. doi: 10.1007/s00392-019-01529-4. Epub 2019 Jul 19.
citation: Stoyanov KM, Hund H, Biener M, Gandowitz J, Riedle C, Lohr J, Mueller-Hennessen M, Vafaie M, Katus HA, Giannitsis E. RAPID-CPU: a prospective study on implementation of the ESC 0/1-hour algorithm and safety of discharge after rule-out of myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2020 Feb;9(1):39-51. doi: 10.1177/2048872619861911. Epub 2019 Jul 12.