Ignite Creation Date:
2024-05-06 @ 9:28 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02984436
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2016-12-01
Brief Title:
High-Sensitivity Cardiac Troponin T to OPtimize Chest Pain Risk Stratification
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
High-Sensitivity Cardiac Troponin T to OPtimize Chest Pain Risk Stratification
Status:
COMPLETED
Status Verified Date:
2020-12
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:
STOP CP
Brief Summary:
This is a prospective observational cohort study of ED patients with acute chest pain or other symptoms suggestive of ACS Blood samples will be collected from study participants for High-Sensitivity Cardiac Troponin T hs-cTnT analysis Results from hs-cTnT will be used for research purposes only
Providers will be blinded to results and participants will be treated by their healthcare providers per the standard of care Participants will have 30 and 90 day phone follow-ups to ascertain study outcomes
Providers will be blinded to results and participants will be treated by their healthcare providers per the standard of care Participants will have 30 and 90 day phone follow-ups to ascertain study outcomes
Detailed Description:
Approximately 8 million - 10 million patients complaining of chest pain present to an Emergency Department ED annually in the United States To avoid missing the diagnosis of acute coronary syndrome ACS physicians use a liberal testing strategy Thus 50 of ED patients with acute chest pain are hospitalized for a comprehensive cardiac evaluation serial cardiac biomarkers and stress testing or angiography However 10 of these patients are ultimately diagnosed with ACS and this pervasive over-triage costs an estimated 10 billion - 13 billion annually Current care patterns for acute chest pain fail to focus health system resources such as hospitalization and stress testing on patients most likely to benefit
It has demonstrated that an accelerated diagnostic protocol ADP called the HEART Pathway which utilizes a clinical decision aid the HEART score and serial Cardiac Troponin cTn measures are sensitive for ACS 99 and can substantially reduce hospitalizations stress testing and cost compared to usual care The HEART Pathway uses contemporary serial cTn measurements at 0 and 3 hours to exclude index myocardial infarction MI and relies on clinical features history ECG age and risk factors to identify patients likely to have downstream events However the HEART Pathway has limitations a It identifies only 20 - 40 of patients for early discharge and b it was developed before high-sensitivity cTn assays became available Able to detect MI earlier and with greater accuracy than contemporary assays hs-cTn assays have the potential to be integrated into decision aids to improve chest pain risk stratification In the near future hs-cTn assays will replace contemporary assays in the United States
It has demonstrated that an accelerated diagnostic protocol ADP called the HEART Pathway which utilizes a clinical decision aid the HEART score and serial Cardiac Troponin cTn measures are sensitive for ACS 99 and can substantially reduce hospitalizations stress testing and cost compared to usual care The HEART Pathway uses contemporary serial cTn measurements at 0 and 3 hours to exclude index myocardial infarction MI and relies on clinical features history ECG age and risk factors to identify patients likely to have downstream events However the HEART Pathway has limitations a It identifies only 20 - 40 of patients for early discharge and b it was developed before high-sensitivity cTn assays became available Able to detect MI earlier and with greater accuracy than contemporary assays hs-cTn assays have the potential to be integrated into decision aids to improve chest pain risk stratification In the near future hs-cTn assays will replace contemporary assays in the United States
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20162880 | OTHER | WIRB | None |
| OCR15652 | OTHER | None | None |