Multicenter Validation of a Predictor Model of ACHD Patients and Cardiac Surgery

March 5, 2024 updated by: University Health Network, Toronto

Novel Model of Preoperative Predictors of Outcome for Adults Undergoing Congenital Cardiac Surgery: Multicenter Model Validation

This multicentre study is to validate prediction modeling for the ACHD population undergoing cardiac surgery. The validation of this prediction model will support and generalize its use as a risk stratification tool in the ACHD population.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

The prediction model resulted from a preceding study, which uniquely based on comorbidities, was developed using 783 adults (>16 years) who underwent surgery for congenital heart disease at Toronto General Hospital (TGH) during 2004-2015. It identifies five pre-operative variables, namely presence of cognitive impairment, hepatic function, >3 chest incisions, anatomy diagnosis, and Body Mass Index <20 and >28, as significant predictors of composite adverse outcomes such as in-hospital mortality, prolonged ventilation (exceeding 7 days) and acute kidney injury.

This newly prediction model developed in a single-center has only been internally validated. It requires further external validation to demonstrate its utility in ACHD populations who require cardiac surgery in other cardiac institutions both nationally and internationally.

Study Type

Observational

Enrollment (Actual)

547

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital - University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All ACHD patients undergoing cardiac surgery in TGH and the other collaborating cardiac centers.

Description

Inclusion Criteria:

  • all ACHD patients >16 years of age undergoing cardiac surgery requiring an open sternotomy or thoracotomy and cardiopulmonary bypass (CPB) or CPB standby at TGH and the collaborating institutions from April 2019.

Exclusion Criteria:

  • CHD patients <16 years of age
  • ACHD patients undergoing chest wall debridement and chest re-explorations for bleeding
  • Non-cardiac surgery procedures and cardiology laboratory interventions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite adverse events
Time Frame: 30 days from the day of surgery.
The composite adverse outcome is defined by in-hospital mortality, prolonged ventilation (exceeding seven days), or acute kidney injury requiring dialysis.
30 days from the day of surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
One-year mortality
Time Frame: 365 days from the day of surgery.
One-year is defined as 365 days from the day of surgery.
365 days from the day of surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Melbourne Health
Montreal Heart Institute
Auckland City Hospital
Providence Healthcare

Investigators

  • Principal Investigator: Jane Heggie, MD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2020

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 2, 2021

First Submitted That Met QC Criteria

March 5, 2021

First Posted (Actual)

March 9, 2021

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-5588

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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