Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05742282
Status:
RECRUITING
Last Update Posted:
2023-02-23
First Post:
2023-02-11
Brief Title:
ASPIRE Aub-haS2 Plus bIomaRkErs
Sponsor:
Hospital Samaritano Paulista
Organization:
Hospital Samaritano Paulista
Study Overview
Official Title:
Validation of the AUB-HAS2 Score in a Brazilian Population and Study of the Additional Impact of Biomarkers in Predicting Perioperative Risk
Status:
RECRUITING
Status Verified Date:
2023-02
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:
ASPIRE
Brief Summary:
ASPIRE is a prospective multicenter observational study that will assess the performance of AUB-HAS2 to predict the occurrence of major adverse cardiovascular events 30-days after a non-cardiac surgery and the additional role of high-sensitivity troponin T and NT-ProBNP biomarkers in the accuracy of different event prediction indexes after non-cardiac procedures
Detailed Description:
Primary objectives
Primary objective of the validation arm to analyze the accuracy of the AUB-HAS2 index in predicting the occurrence of myocardial infarction stroke and death within 30 days after non-cardiac surgeries
Primary objective biomarker arm to analyze the additional role of high-sensitivity troponin T and NT-ProBNP biomarkers in the accuracy of different event prediction indexes after non-cardiac surgeries
Secondary objectives
To analyze the potentially preventable factors related to adverse outcomes after non-cardiac surgeries in order to offer subsidies for more assertive guidelines regarding the implementation of perioperative protection strategies Compare the performance of these scores with others that have already been validated ACP and Lee - see Annex A
Primary objective of the validation arm to analyze the accuracy of the AUB-HAS2 index in predicting the occurrence of myocardial infarction stroke and death within 30 days after non-cardiac surgeries
Primary objective biomarker arm to analyze the additional role of high-sensitivity troponin T and NT-ProBNP biomarkers in the accuracy of different event prediction indexes after non-cardiac surgeries
Secondary objectives
To analyze the potentially preventable factors related to adverse outcomes after non-cardiac surgeries in order to offer subsidies for more assertive guidelines regarding the implementation of perioperative protection strategies Compare the performance of these scores with others that have already been validated ACP and Lee - see Annex A
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