NCT03111862

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,567

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

December 6, 2018

Status Verified

December 1, 2018

Enrollment Period

1.2 years

First QC Date

April 4, 2017

Last Update Submit

December 4, 2018

Conditions

Acute Coronary SyndromeNSTEMI - Non-ST Segment Elevation MI

Outcome Measures

Primary Outcomes (1)

  • All-cause death

    Survival free of all-cause death

    30 days and 3 months

Secondary Outcomes (3)

  • Acute Myocardial Infarction

    30 days and 3 months

  • Rehospitalization for Acute Coronary Syndrome

    30 days and 3 months

  • Rehospitalization for nonelective percutaneous coronary intervention

    30 days and 3 months

Interventions

NSTEMI Rule-Out according to hs-TnTDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive patients presenting to CPU with suspected ACS based on chest pain or chest pain equivalent symptoms

You may qualify if:

  • eligible to consent
  • \>18 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universtity Hospital

Heidelberg, Germany

Location

Related Publications (5)

  • 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.

    PMID: 40154974DERIVED

  • 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.

    PMID: 37131096DERIVED

  • 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.

    PMID: 33033102DERIVED

  • 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.

    PMID: 31325044DERIVED

  • 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.

    PMID: 31298551DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Clinical Chemistry, in particular High-sensitivity troponin T

MeSH Terms

Conditions

Acute Coronary SyndromeNon-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesMyocardial InfarctionInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Moritz Biener, MD

    University Hospital Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 13, 2017

Study Start

June 1, 2017

Primary Completion

August 1, 2018

Study Completion

November 1, 2018

Last Updated

December 6, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)