Safety and Efficacy of Hs-cTnT Protocols

NCT ID: NCT05484544

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1167 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-02-01
• Study Completion Date: 2014-04-30

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.

Detailed Description

This is a prospective observational study conducted at Skåne University Hospital (Lund, Sweden). Patients presenting with non-traumatic chest pain and for whom hs-cTnT testing was ordered at presentation will be enrolled between february 2013 to April 2014 after providing written informed consent. Patients with STEMI during index visit and those with severe communication barriers will not be enrolled. Enrolled patients will have a second blood sample for hs-cTnT analyzed 1 h after the first sample. Patients with hemolysis with a hemoglobin concentration >0.1 g/dl, H-index >=100 in either the 0- or

1-h sample will be excluded. Clinical data and 1-h high sensitivity troponin T samples will be collected by research assistants. Further diagnostic testing and treatment will be performed, as in routine care, at the discretion of the responsible physician.

Conditions

Chest Pain; Diagnosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

High sensitivity troponin T

Collection of hs-cTnT samples

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Ulf Ekelund

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulf Ekelund, Professor

Role: PRINCIPAL_INVESTIGATOR

Lund University

References

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.

Reference Type: BACKGROUND

PMID: 27150684 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37131096 (View on PubMed)

Other Identifiers

HscTnTProtocols

Identifier Type: -

Identifier Source: org_study_id