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Acute Coronary SyndromeNCT03111862

Safety of Accelerated Rule-out Protocols in Patients Admitted With Chest Pain to a Crowded Chest Pain Unit (CPU)

An observational study of Acute Coronary Syndrome and NSTEMI - Non-ST Segment Elevation MI, run by University Hospital Heidelberg at 1 site in Germany.

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

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NSTEMI Rule-Out according to hs-TnT
How many people
3,567 participants
Where
1 siteGermany
Study dates
1 Jun 2017to 1 Nov 2018
How long will I take part?
3 Months
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: Consecutive patients presenting to CPU with suspected ACS based on chest pain or chest pain equivalent symptoms

Who may be able to join

  • eligible to consent
  • >18 years

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Universtity Hospital

    Heidelberg

Other trials in Germany

About this study

Official title: Observational Study on the Safety of Accelerated Rule-out Protocols in Patients Admitted With Chest Pain to a Crowded CPU

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.

Read the 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.

Being tested
NSTEMI Rule-Out according to hs-TnT
Medical subject headings
Acute Coronary Syndrome, Non-ST Elevated Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NSTEMI Rule-Out according to hs-TnTDiagnostic test

    Rule-Out according to the rapid rule-out protocol of the current ESC Guidelines

What is being measured

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

  1. All-cause death

    Survival free of all-cause death

    Measured: 30 days and 3 months

Secondary outcomes (3)

  1. Acute Myocardial Infarction

    Non-STEMI and STEMI

    Measured: 30 days and 3 months

  2. Rehospitalization for Acute Coronary Syndrome

    Acute Coronary Syndrome including unstable angina, non-STEMI and STEMI

    Measured: 30 days and 3 months

  3. Rehospitalization for nonelective percutaneous coronary intervention

    Unplanned PCI

    Measured: 30 days and 3 months

Timeline

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

  1. First posted13 Apr 2017
  2. Study start1 Jun 2017
  3. Primary completion1 Aug 2018
  4. Study completion1 Nov 2018

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
3,567 participants (actual)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03111862
Sponsor's protocol ID
UHHD-BM-004
Status last verified
Dec 2018
First submitted
4 Apr 2017
Last updated
6 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Champetier A, Lopez-Ayala P, Reich C, Boeddinghaus J, Cattin P, Koechlin L, Miro O, Christ M, Keller DI, Martin-Sanchez FJ, Morawiec B, Parenica J, Kaplan E, Bima P, Recuenco LH, Hure G, Herzka D, Wildi K, Crisanti L, Durak K, Schaffer JS, Zimmermann T, Mahfoud F, Lindahl B, Giannitsis E, Strebel I, Mueller C; APACE; TRAPID-AMI Investigatorsn; TRAPID-AMI Investigators. Machine learning for diagnosing non-ST-segment elevation myocardial infarction: a derivation and validation study. EClinicalMedicine. 2026 Jul 9;97:104055. doi: 10.1016/j.eclinm.2026.104055. eCollection 2026 Jul.

    PubMed 42473534

  • Reich C, Yildirim M, Salbach C, Biener M, Lopez-Ayala P, Muller C, Frey N, Giannitsis E. Resolving the observe zone: validation of the ESC 0/3-hour and the APACE criteria for NSTEMI triage. Open Heart. 2025 Mar 28;12(1):e003047. doi: 10.1136/openhrt-2024-003047.

    PubMed 40154974

  • Neumann JT, Twerenbold R, Ojeda F, Aldous SJ, Allen BR, Apple FS, Babel H, Christenson RH, Cullen L, Di Carluccio E, Doudesis D, Ekelund U, Giannitsis E, Greenslade J, Inoue K, Jernberg T, Kavsak P, Keller T, Lee KK, Lindahl B, Lorenz T, Mahler SA, Mills NL, Mokhtari A, Parsonage W, Pickering JW, Pemberton CJ, Reich C, Richards AM, Sandoval Y, Than MP, Toprak B, Troughton RW, Worster A, Zeller T, Ziegler A, Blankenberg S; ARTEMIS study group. Personalized diagnosis in suspected myocardial infarction. Clin Res Cardiol. 2023 Sep;112(9):1288-1301. doi: 10.1007/s00392-023-02206-3. Epub 2023 May 2.

    PubMed 37131096

  • 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.

    PubMed 33033102

  • 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.

    PubMed 31325044

  • 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.

    PubMed 31298551

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Coronary Syndrome and NSTEMI - Non-ST Segment Elevation MI, run by University Hospital Heidelberg at 1 site in Germany.

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 2 inclusion and 5 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 6 Dec 2018. 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 Germany. 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?

All-cause death (time frame: 30 days and 3 months). 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 NCT03111862, which also lists 6 linked publications.

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 6 Dec 2018.

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