Ignite Creation Date:
2024-05-06 @ 3:45 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02364271
Status:
COMPLETED
Last Update Posted:
2021-04-15
First Post:
2015-02-03
Brief Title:
Early Risk Stratification in ED Chest Pain Patients
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Improving Early Risk Stratification in Patients Presenting to Emergency Departments With Undifferentiated Chest Pain
Status:
COMPLETED
Status Verified Date:
2021-04
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:
In the management of adult chest pain patients presenting to an Emergency Department ED with suspected acute coronary syndrome ACS we aimed to evaluate the diagnostic accuracy of the combined use of a modified Thrombolysis in Myocardial Infarction TIMI score and a modified HEART score with high-sensitive cardiac troponin T hs-cTnT to rule out major adverse cardiac events MACE in 30-days
Detailed Description:
Chest pain is one of the most common complaints in patients presenting to emergency departments ED globally representing 25 of all ED presentations in Hong Kong Acute coronary syndrome ACS cannot be immediately excluded in the majority of patients presenting with chest pain and is confirmed in about 15-25 cases The current evaluation of patients in most EDs is a lengthy process that involves serial ECGs and troponin tests taken 3-6 hours apart However challenges over ED crowding and the need for acceptable risk stratification have prompted the search for safe cheap but effective accelerated chest pain pathways
An ever increasing evidence base is emerging from emergency departments in different geographical settings using different combinations of clinical assessment tools more rapid biochemical tests and variable outcomes While making an accurate diagnosis is clearly important from the patients perspective it is more important to minimize the risk of adverse events Therefore the identification of tools which allow risk stratification to permit very low risks of MACE is more clinically relevant to ED specialists than the precise diagnostic label applied to the patient
In the Asia-Pacific region a 2-hour diagnostic protocol involving serial point-of-care biomarkers such as troponin I creatine kinase MB and myoglobin combined with electrocardiograph ECG changes and a Thrombolysis in Myocardial Infarction TIMI score has been shown to safely exclude 30-day MACE in low risk patients with chest pain Highly sensitive troponin T hs-cTnT and troponin I hs-cTnI perform well in the early diagnosis of acute myocardial infarction AMI non-ST elevation myocardial infarction NSTEMI and in the prediction of two year mortality Undetectable levels of hs-cTnT alone at initial blood testing appears to rule-out 60-day NSTEMI with a negative predictive value of 94 and a sensitivity of 90 A TIMI score incorporating hs-cTnT was no better at predicting 30-day MACE than front-door TIMI alone without measurement of biomarkers but the value of a TIMI score of zero in ruling-out low risk patients was not demonstrated
Despite evidence favouring early rule out pathways there is still a need for further validation and refinement of such tools using different diagnostic pathways in other clinical settings and with other clinical tools such as HEART
In this study we aimed firstly to evaluate the effectiveness of a combined use of an early modified TIMI score with hs-cTnT and a modified HEART score to rule out MACE in 30 days Applying this protocol in clinical practice has the potential to reduce ED waiting times ED crowding and hospital admission rates for chest pain patients
An ever increasing evidence base is emerging from emergency departments in different geographical settings using different combinations of clinical assessment tools more rapid biochemical tests and variable outcomes While making an accurate diagnosis is clearly important from the patients perspective it is more important to minimize the risk of adverse events Therefore the identification of tools which allow risk stratification to permit very low risks of MACE is more clinically relevant to ED specialists than the precise diagnostic label applied to the patient
In the Asia-Pacific region a 2-hour diagnostic protocol involving serial point-of-care biomarkers such as troponin I creatine kinase MB and myoglobin combined with electrocardiograph ECG changes and a Thrombolysis in Myocardial Infarction TIMI score has been shown to safely exclude 30-day MACE in low risk patients with chest pain Highly sensitive troponin T hs-cTnT and troponin I hs-cTnI perform well in the early diagnosis of acute myocardial infarction AMI non-ST elevation myocardial infarction NSTEMI and in the prediction of two year mortality Undetectable levels of hs-cTnT alone at initial blood testing appears to rule-out 60-day NSTEMI with a negative predictive value of 94 and a sensitivity of 90 A TIMI score incorporating hs-cTnT was no better at predicting 30-day MACE than front-door TIMI alone without measurement of biomarkers but the value of a TIMI score of zero in ruling-out low risk patients was not demonstrated
Despite evidence favouring early rule out pathways there is still a need for further validation and refinement of such tools using different diagnostic pathways in other clinical settings and with other clinical tools such as HEART
In this study we aimed firstly to evaluate the effectiveness of a combined use of an early modified TIMI score with hs-cTnT and a modified HEART score to rule out MACE in 30 days Applying this protocol in clinical practice has the potential to reduce ED waiting times ED crowding and hospital admission rates for chest pain patients
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