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OpenTrials
Completed

NCT Number: NCT02002546

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erlanger Baroness Medical Center

Chattanooga, Tennessee, 37403, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • Patients with chest pain not deemed to warrant cardiac screening
  • Blunt chest trauma
  • Tachyarrhythmia (ventricular tachycardia, supraventricular tachycardia, or rapid atrial fibrillation)
  • Cardiac Arrest prior to arrival
  • Hemodynamically unstable patients
  • Pulmonary edema requiring CPAP, BIPAP, or mechanical ventilation
  • Baseline i-STAT troponin measurement greater than 1.0 ng/ml
  • Baseline and 2-hour i-STAT Troponin measurements not obtained
  • Patient (or Legal Representative) unable or unwilling to provide written informed consent
  • Subject unwilling or unlikely to comply with study procedures, including protocol-specific blood sampling
  • Subject unwilling, unable, or deemed unlikely to respond or participate in telephone follow-up
  • Vulnerable populations as deemed inappropriate for the study

Treatment and study plan

Primary outcomes

  1. Change in Troponin value over a two hour interval.

    Time frame: 2 hours after baseline

Sponsors and collaborators

Lead sponsor

Chattanooga-Hamilton County Hospital Authority

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Dec 6, 2013
Registry last updated
Jan 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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