Ignite Creation Date:
2024-05-05 @ 9:45 PM
Last Modification Date:
2024-10-26 @ 10:08 AM
Study NCT ID:
NCT00950469
Status:
COMPLETED
Last Update Posted:
2009-07-31
First Post:
2009-07-30
Brief Title:
TnThs for Identification Myocardial Infarction
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Comparison of the New High Sensitive Cardiac Troponin T With the 4th Generation Troponin-T Myoglobin Heart-type Fatty Acid Binding Protein for Early Identification of Myocardial Necrosis in Patients With Suspected Acute Coronary Syndrome
Status:
COMPLETED
Status Verified Date:
2009-07
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:
OBJECTIVESBACKGROUND We sought to determine the early diagnostic value of the new high sensitive cardiac troponin T assay TnThs in suspected acute coronary syndrome ACS and to compare it with the 4th generation cTnT assay from the same manufacturer myoglobin and heart-type fatty acid binding protein h-FABP
METHODS The study consisted of 94 patients with chest pain admitted to the chest pain unit with the diagnosis of suspected ACS without ST-Elevation Patients were divided according to time from onset of symptoms to presentation into an early presenter group 4 hours and a late presenter group 4 hours
A median of 6 samples range 2-8 were available per patient The diagnostic performance of TnThs was assessed using ROC analysis and areas under the curve AUC of baseline and follow-up results of TnThs cTnT myoglobin and h-FABP were compared using c-statistics
RESULTS The TnThs assay allows an excellent prediction of non-ST-segment-elevation myocardial infarction non-STEMI at presentationA follow-up sample improves diagnostic performance in a time dependent manner The AUC of the TnThs was superior to cTnT at all time points
CONCLUSIONS A baseline sample of TnThs allows an earlier prediction of non-STEMI than the less sensitive and precise 4th generation cTnT assay The excellent performance of TnThs at baseline and follow-up might obviate the need for other early necrosis markers
METHODS The study consisted of 94 patients with chest pain admitted to the chest pain unit with the diagnosis of suspected ACS without ST-Elevation Patients were divided according to time from onset of symptoms to presentation into an early presenter group 4 hours and a late presenter group 4 hours
A median of 6 samples range 2-8 were available per patient The diagnostic performance of TnThs was assessed using ROC analysis and areas under the curve AUC of baseline and follow-up results of TnThs cTnT myoglobin and h-FABP were compared using c-statistics
RESULTS The TnThs assay allows an excellent prediction of non-ST-segment-elevation myocardial infarction non-STEMI at presentationA follow-up sample improves diagnostic performance in a time dependent manner The AUC of the TnThs was superior to cTnT at all time points
CONCLUSIONS A baseline sample of TnThs allows an earlier prediction of non-STEMI than the less sensitive and precise 4th generation cTnT assay The excellent performance of TnThs at baseline and follow-up might obviate the need for other early necrosis markers
Detailed Description:
None
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