ASPIRE (Aub-haS2 Plus bIomaRkErs) (ASPIRE)

Validation of the AUB-HAS2 Score in a Brazilian Population and Study of the Additional Impact of Biomarkers in Predicting Perioperative Risk

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Perioperative Medicine

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 Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: PEDRO DE BARROS E SILVA, MD PhD; Phone Number: 551128275000; Email: centrodeestudos@samaritanopaulista.com.br

Study Locations

• Brazil
  • São Paulo, Brazil
    • Hospital Samaritano Paulista
    • Contact: Pedro de Barros e Silva, MD, MHS, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients ≥ 40 years, that will undergo non-cardiac procedures, with expected hospitalization for at least 24 hours postoperatively.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RATE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS	COMPOSITE OF DEATH, MYOCARDIAL INFARCTION AND STROKE	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
RATE OF MYOCARDIAL INJURY	30 days

Collaborators and Investigators

• Sponsor: Hospital Samaritano Paulista

Study record dates

Study Major Dates

• Study Start (Estimated): June 21, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: February 11, 2023
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 001/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data can be shared under formal requisition and justification

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No