Usefulness of a 2-hour Delta Troponin-I During the ED Identification and Exclusion of Acute Myocardial Infarction
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/26/2018 |
| Start Date: | January 2014 |
| End Date: | September 4, 2015 |
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.
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.
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.
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.
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
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