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

NCT02002546 | Completed

• 1 other identifier: IRB# 13-069
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Acute Coronary Syndrome

Keywords

Heart Attack; Myocardial Infarction; Angina; Chest Pain

Outcome Measures

Primary Outcomes (1)

• Change in Troponin value over a two hour interval.

  2 hours after baseline

Study Arms (1)

ED chest pain presenting patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Chattanooga-Hamilton County Hospital Authority: lead

Study Sites (1)

Erlanger Baroness Medical Center

Chattanooga, Tennessee, 37403, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Myocardial Infarction; Angina Pectoris; Chest Pain

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 6, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: September 4, 2015
• Last Updated: January 24, 2018

Record last verified: 2018-01

Locations

US (1)