MedTrace Logo

Evaluation of hsTnI in the Management of Patients With Chest Pain in the Emergency Department

NCT02789904 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2021-04-19

No results posted yet for this study

Summary

Current standard of care algorithm using high sensitivity troponin T (hsTnT) requires up to 6.5 hours to diagnose an ACS. Data will be stratified based upon time of symptom onset and gender. A health economics and outcome model will be applied using the optimal high sensitivity troponin I (hsTnI) cut-off values and draw times to determine the cost and outcome benefits predicted from optimal utilization of hsTnI.

A chest pain registry will be set up to compare high sensitivity troponin I (hsTnI) versus high sensitivity troponin T (hsTnT) for all patients who present to the emergency department and require a blood draw. The outcomes of these patients will be tracked over the study period.

The purpose of conducting this study evaluation is:

1. To shorten the chest pain protocol for suitable patients to \< 3 hours compared to the current 6 hours protocol with the latest high sensitivity Troponin I assays.
2. To determine the validity of Abbott ARCHITECT i2000 and Beckman Coulter ACCESS AccuTnI+3 with an accelerated algorithm in comparison to the standard of care acute coronary syndrome (ACS) algorithm and high sensitivity troponin T (hsTnT) assay, to rule-out or rule-in for an ACS within 3 hours of presentation to the emergency room (ER) with isolated suspected ACS.
3. To establish the local reference norms for hsTnI assays.

Conditions

Interventions

OTHER

blood taking

Blood taking will be done for chest pain patients presenting with chest pain at 0, 1 and 2 hour

Sponsors & Collaborators

  • Singapore General Hospital

    collaborator OTHER

  • Beckman Coulter GmbH

    collaborator INDUSTRY

  • Abbott

    collaborator INDUSTRY

  • National Heart Centre Singapore

    lead OTHER

Principal Investigators

  • Dr Tan Wei Chieh Jack, MBBS · National Heart Centre Singapore

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-05
Primary Completion
2017-11-01
Completion
2017-11-01

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02789904 on ClinicalTrials.gov