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

Completed

Conditions studied: Acute Coronary Syndrome

In brief

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.

Key facts

Study ID

NCT02002546

Run by

Chattanooga-Hamilton County Hospital Authority

People needed

240

Starts

2014-01-01

Expected to finish

2015-09-04

Last updated by the study team

2018-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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