Ignite Creation Date:
2024-05-06 @ 2:16 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02002546
Status:
COMPLETED
Last Update Posted:
2018-01-24
First Post:
2013-12-02
Brief Title:
Usefulness of a 2-hour Delta Troponin-I During the ED Identification and Exclusion of Acute Myocardial Infarction
Sponsor:
Chattanooga-Hamilton County Hospital Authority
Organization:
Chattanooga-Hamilton County Hospital Authority
Study Overview
Official Title:
Usefulness of a 2-hour Delta Troponin-I During the ED Identification and Exclusion of Acute Myocardial Infarction
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 02ngml 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
2 In chest pain patients with suspected acute coronary syndrome whose baseline troponin is above the 99th percentile but less than 02ngml 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
Detailed 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 2Demonstrate 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None