Safety and Efficacy of Hs-cTnT Protocols

November 14, 2023 updated by: Ulf Ekelund, Region Skane
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1167

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Consecutive ED chest pain patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day MACE
Time Frame: 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
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day MACE without UA
Time Frame: 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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Investigators

  • Principal Investigator: Ulf Ekelund, Professor, Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2013

Primary Completion (Actual)

April 30, 2014

Study Completion (Actual)

April 30, 2014

Study Registration Dates

First Submitted

July 31, 2022

First Submitted That Met QC Criteria

July 31, 2022

First Posted (Actual)

August 2, 2022

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HscTnTProtocols

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data sharing will be made upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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