NCT04787705

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
547

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

March 10, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 7, 2024

Status Verified

February 1, 2024

Enrollment Period

4.7 years

First QC Date

March 2, 2021

Last Update Submit

March 5, 2024

Conditions

Adult Congenital Heart DiseaseCardiac Surgery

Keywords

Prediction model

Outcome Measures

Primary Outcomes (1)

  • Composite adverse events

    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 Outcomes (1)

  • One-year mortality

    365 days from the day of surgery.

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital - University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jane Heggie, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 9, 2021

Study Start

March 10, 2020

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

March 7, 2024

Record last verified: 2024-02

Locations

CA(1)