NCT05742282

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Jun 2025Oct 2026

First Submitted

Initial submission to the registry

February 11, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
2.3 years until next milestone

Study Start

First participant enrolled

June 21, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

1.3 years

First QC Date

February 11, 2023

Last Update Submit

May 15, 2025

Conditions

Perioperative Medicine

Outcome Measures

Primary Outcomes (1)

  • RATE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS

    COMPOSITE OF DEATH, MYOCARDIAL INFARCTION AND STROKE

    30 days

Secondary Outcomes (1)

  • RATE OF MYOCARDIAL INJURY

    30 days

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Age ≥ 40 years, in the preoperative period of non-cardiac procedures, with expected hospitalization for at least 24 hours postoperatively.

You may not qualify if:

  • Refusal to sign the informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Samaritano Paulista

São Paulo, Brazil

Location

Central Study Contacts

PEDRO DE BARROS E SILVA, MD PhD

CONTACT

551128275000centrodeestudos@samaritanopaulista.com.br

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Clinical Research

Study Record Dates

First Submitted

February 11, 2023

First Posted

February 23, 2023

Study Start

June 21, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

May 20, 2025

Record last verified: 2025-05

Locations

BR(1)