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ASPIRE (Aub-haS2 Plus bIomaRkErs)

Sponsor
Hospital Samaritano Paulista (Other)
Overall Status
Recruiting
CT.gov ID
NCT05742282
Collaborator
(none)
2,500
Enrollment
1
Location
18.6
Anticipated Duration (Months)
134.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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
    Anticipated Enrollment :
    2500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Validation of the AUB-HAS2 Score in a Brazilian Population and Study of the Additional Impact of Biomarkers in Predicting Perioperative Risk
    Actual Study Start Date :
    Jan 12, 2023
    Anticipated Primary Completion Date :
    Apr 1, 2024
    Anticipated Study Completion Date :
    Aug 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. RATE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS [30 days]

      COMPOSITE OF DEATH, MYOCARDIAL INFARCTION AND STROKE

    Secondary Outcome Measures

    1. RATE OF MYOCARDIAL INJURY [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Samaritano Paulista São Paulo Brazil

    Sponsors and Collaborators

    • Hospital Samaritano Paulista

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pedro Gabriel Melo de Barros e Silva, Director of Clinical Research, Hospital Samaritano Paulista
    ClinicalTrials.gov Identifier:
    NCT05742282
    Other Study ID Numbers:
    • 001/23
    First Posted:
    Feb 23, 2023
    Last Update Posted:
    Feb 23, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Feb 23, 2023