Usefulness of a 2-hour Delta Troponin-I During the ED Identification and Exclusion of Acute Myocardial Infarction

January 23, 2018 updated by: Chattanooga-Hamilton County Hospital Authority
  1. In chest pain patients with suspected acute coronary syndrome, a 2-hr delta Troponin-I as measured by the i-STAT immunoassay reliably identifies and excludes an acute myocardial infarction.
  2. In chest pain patients with suspected acute coronary syndrome whose baseline troponin is above the 99th percentile but less than 0.2ng/ml, a 2hr delta Troponin-I as measured by the i-STAT immunoassay accurately discriminates between acute myocardial infarction and non-acute myocardial infarction troponin elevations.

Study Overview

Status

Completed

Conditions

Detailed Description

Primary Aims: 1) Demonstrate that a 2hr delta troponin as measured by the i-STAT platform can reliably identify and exclude MI on the initial ED evaluation. 2)Demonstrate that a 2hr delta troponin is useful in the discrimination AMI versus non-AMI conditions in patients with low abnormal baseline Troponin-I values.

Secondary Aims: 1) Demonstrate that a positive 2-hr delta troponin-I identifies patients at highest risk for 30 day ACE. 2) Other Secondary aims TBD.

Study Type

Observational

Enrollment (Actual)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Baroness Medical Center

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients presenting to the Emergency Department with chest pain or similar symptoms, and risk factors for ACS.

Description

Inclusion Criteria:

  1. Adult patients 18 years of age or older
  2. Chest pain suspicious for ACS
  3. Absence of ST-segment elevation AMI (STEMI) or STEMI equivalent on the initial ECG
  4. Baseline i-STAT troponin less or equal to 1.0 ng/ml
  5. Enrollment initiated before 2 hour 'delt' troponin value available for review
  6. Ability and willingness to participate and cooperate with telephone follow-up evaluations

Exclusion Criteria:

  1. ST-elevation or other ECG criteria that results in the diagnosis of AMI and results in patient being sent for percutaneous coronary interventions (PCI) or being treated with thrombolytics
  2. Patients with chest pain not deemed to warrant cardiac screening
  3. Blunt chest trauma
  4. Tachyarrhythmia (ventricular tachycardia, supraventricular tachycardia, or rapid atrial fibrillation)
  5. Cardiac Arrest prior to arrival
  6. Hemodynamically unstable patients
  7. Pulmonary edema requiring CPAP, BIPAP, or mechanical ventilation
  8. Baseline i-STAT troponin measurement greater than 1.0 ng/ml
  9. Baseline and 2-hour i-STAT Troponin measurements not obtained
  10. Patient (or Legal Representative) unable or unwilling to provide written informed consent
  11. Subject unwilling or unlikely to comply with study procedures, including protocol-specific blood sampling
  12. Subject unwilling, unable, or deemed unlikely to respond or participate in telephone follow-up
  13. Vulnerable populations as deemed inappropriate for the study

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

Cohorts and Interventions

Group / Cohort
ED chest pain presenting patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Troponin value over a two hour interval.
Time Frame: 2 hours after baseline
2 hours after baseline

Collaborators and Investigators

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

Sponsor

Chattanooga-Hamilton County Hospital Authority

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

January 1, 2014

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

September 4, 2015

Study Registration Dates

First Submitted

December 2, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (ESTIMATE)

December 6, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB# 13-069

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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