Safety and Efficacy of Hs-cTnT Protocols

• Sponsor: Region Skane (Other)
• Overall Status: Completed
• CT.gov ID: NCT05484544
• Collaborator: (none)
• Enrollment: 1,167
• Actual Duration (Months): 14.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chest Pain; Diagnosis	Diagnostic Test: High sensitivity troponin T

Study Design

• Study Type: Observational
• Actual Enrollment: 1167 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Safety and Efficacy of Hs-cTnT Protocols
• Actual Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Apr 30, 2014
• Actual Study Completion Date: Apr 30, 2014

Outcome Measures

Primary Outcome Measures

1. 30-day MACE [30 days]

   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

Secondary Outcome Measures

1. 30-day MACE without UA [30 days]

   Defined as an adjudicated diagnosis of AMI, cardiac arrest, cardiogenic shock, ventricular arrhythmia requiring intervention, atrioventricular block requiring intervention, or death of a cardiac or unknown cause

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Region Skane

Investigators

• Principal Investigator: Ulf Ekelund, Professor, Lund University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Mokhtari A, Borna C, Gilje P, Tydén P, Lindahl B, Nilsson HJ, Khoshnood A, Björk 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.

• Responsible Party: Ulf Ekelund, Professor, Region Skane
• ClinicalTrials.gov Identifier: NCT05484544
• Other Study ID Numbers: HscTnTProtocols
• First Posted: Aug 2, 2022
• Last Update Posted: Aug 2, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Chest Pain

Study Results

No Results Posted as of Aug 2, 2022