NCT05484544

Brief Summary

Chest pain is a common presenting complaint among patients in the emergency department (ED). A large portion of patients with chest pain undergo lengthy assessment in the ED or are admitted to rule out acute oronary syndrome (ACS), often with stress testing, creating a substantial health care burden. The new high-sensitivity cardiac troponin assays allow use of shorter time intervals for repeated blood samples and may improve care for chest pain patients. The aim of this cohort is to evaluate high-sentivity troponin based protocols for ruling out and ruling in ACS in the ED.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,167

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

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

Study Start

First participant enrolled

February 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2014

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2022

Completed
Last Updated

November 18, 2023

Status Verified

September 1, 2022

Enrollment Period

1.2 years

First QC Date

July 31, 2022

Last Update Submit

November 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 30-day MACE

    MACE within 30 days including the index visit. MACE was defined as an adjudicated diagnosis of AMI, UA, cardiac arrest, cardiogenic shock, ventricular arrhythmia requiring intervention, atrioventricular block requiring intervention, or death of a cardiac or unknown cause

    30 days

Secondary Outcomes (1)

  • 30-day MACE without UA

    30 days

Interventions

Collection of hs-cTnT samples

Eligibility Criteria

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

Consecutive ED chest pain patients

You may qualify if:

  • \>=18 years of age
  • Presented to the ED with non-traumatic chest pain/discomfort
  • Hs-cTnT testing was ordered at presentation

You may not qualify if:

  • STEMI at presentation
  • Severe communication barriers
  • Hemolysis with a hemoglobin concentration\>0.1 g/dl, H-index\>=100

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Mokhtari A, Borna C, Gilje P, Tyden P, Lindahl B, Nilsson HJ, Khoshnood A, Bjork J, Ekelund U. A 1-h Combination Algorithm Allows Fast Rule-Out and Rule-In of Major Adverse Cardiac Events. J Am Coll Cardiol. 2016 Apr 5;67(13):1531-1540. doi: 10.1016/j.jacc.2016.01.059.

    PMID: 27150684BACKGROUND
  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biobank bloodsamples

MeSH Terms

Conditions

Chest PainDisease

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Ulf Ekelund, Professor

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 31, 2022

First Posted

August 2, 2022

Study Start

February 1, 2013

Primary Completion

April 30, 2014

Study Completion

April 30, 2014

Last Updated

November 18, 2023

Record last verified: 2022-09