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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02002546
• Other study ID #: IRB# 13-069
• Status: Completed
• Phase: N/A
• First received: December 2, 2013
• Last updated: January 23, 2018
• Start date: January 2014
• Est. completion date: September 4, 2015

Study information

• Verified date: January 2018
• Source: Chattanooga-Hamilton County Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: September 4, 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
United States	Erlanger Baroness Medical Center	Chattanooga	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Chattanooga-Hamilton County Hospital Authority

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Troponin value over a two hour interval.		2 hours after baseline