Validation of the AUB-HAS2 Score in a Brazilian Population and Study of the Additional Impact of Biomarkers in Predicting Perioperative Risk
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 2,500
- Locations
- 1
- Primary Endpoint
- RATE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 40 years, in the preoperative period of non-cardiac procedures, with expected hospitalization for at least 24 hours postoperatively.
Exclusion Criteria
- •Refusal to sign the informed consent form.
Outcomes
Primary Outcomes
RATE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS
Time Frame: 30 days
COMPOSITE OF DEATH, MYOCARDIAL INFARCTION AND STROKE
Secondary Outcomes
- RATE OF MYOCARDIAL INJURY(30 days)
Investigators
Pedro Gabriel Melo de Barros e Silva
Director of Clinical Research
Hospital Samaritano Paulista