NCT07293533

Brief Summary

Grouping relevant demographic and clinical information at specific stratified levels, and in correlation with the required resource sets, represents the possibility to adapt, improve, and innovate in cardiac surgery programs. In this path, the pursuit of implementing large databases for continuous improvement cycles becomes the foundation of the entire process. In Brazil, where structural and socioeconomic differences are significant, the standardization and sustainability of a large database become a major challenge. Projects like REPLICCAR (São Paulo Cardiovascular Surgery Registry) and BYPASS Registry, which were created to identify improvement opportunities, were temporary. The absence of a continuous multicenter registry makes it difficult to understand risk-adjusted patient outcomes and to implement cost-effective quality initiatives. For example, in 2022, the Ministry of Health launched the QualiSUS Cardio program, which began to consider hospital reimbursement not only in terms of surgical volume but also in relation to mortality, length of stay, and readmission rates after cardiac surgery. Changes like this already occur in various scenarios where payers, whether public or private, seek reimbursement through value-based models. However, for this to happen, the results need to be adjusted to patient risk. Otherwise, hospitals treating more severe patients would be at a disadvantage. This study aims to develop CABG-BraSCORE, a risk score to stratify patients referred for CABG surgery, adjusting outcomes to patient risk, and seeking continuous improvement for cardiac surgery programs in Brazil.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
2,400

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Apr 2024

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Apr 2024Jul 2026

Study Start

First participant enrolled

April 1, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Expected
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

2.1 years

First QC Date

November 25, 2025

Last Update Submit

December 6, 2025

Conditions

CABG-patients

Keywords

DatabasesDatabase Management SystemsCoronary Artery BypassPredictions

Outcome Measures

Primary Outcomes (2)

  • In-hospital mortality

    death occurring at any point during the hospitalization for surgery, even if after 30 days

    up to 3 months during hospital admission for CABG

  • 30-day mortality

    death occurring after discharge from the hospital, but within 30-days of the procedure

    30-days of the procedure

Secondary Outcomes (2)

  • Prolonged Hospital Stay

    postoperative hospital stay longer than 14 days

  • 30-day readmission

    30-days after surgery

Other Outcomes (1)

  • Data quality score

    Assessment will be performed on registries that have completed a 30-day active data collection period.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of all consecutive patients undergoing isolated CABG at the participating centers during the study period.

You may qualify if:

  • Patients submitted to isolated coronary artery bypass grafting at participating centers

You may not qualify if:

  • Emergency or salvage CABG procedures.
  • Associated procedures (e.g., valve surgery, aortic surgery).
  • Missing mandatory data in the registry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital de Messejana

Fortaleza, Ceará, Brazil

Location

Hospital Alberto Urquiza Wanderley

João Pessoa, Paraíba, 58040-300, Brazil

Location

USP Heart Institute

São Paulo, São Paulo, 05403-900, Brazil

Location

Instituto Nacional de Cardiologia de Laranjeiras

Rio de Janeiro, 22240-002, Brazil

Location

Beneficência Portuguesa de São Paulo

São Paulo, 01323-001, Brazil

Location

Related Publications (1)

  • Atik FA. Registries and Evidence-Based Medicine. Arq Bras Cardiol. 2024 Aug 2;121(6):e20240330. doi: 10.36660/abc.20240330. eCollection 2024. No abstract available. English, Portuguese.

    PMID: 39109690BACKGROUND

Related Links

Study Officials

  • BIANCA MARIA MAGLIA ORLANDI, Post doctoral resercher

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

November 25, 2025

First Posted

December 19, 2025

Study Start

April 1, 2024

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations

BR(5)