Adult Congenital Heart DiseaseNCT04787705
Multicenter Validation of a Predictor Model of ACHD Patients and Cardiac Surgery
An observational study of Adult Congenital Heart Disease and Cardiac Surgery, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Adult Congenital Heart Disease, Cardiac Surgery
- How many people
- 547 participants
- Where
- 1 siteCanada
- Study dates
- 10 Mar 2020to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All ACHD patients undergoing cardiac surgery in TGH and the other collaborating cardiac centers.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto General Hospital - University Health Network
Toronto, Ontario, M5G 2C4
About this study
Official title: 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.
Read the 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.
- Conditions
- Adult Congenital Heart Disease, Cardiac Surgery
- Keywords
- Prediction model
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite adverse events
The composite adverse outcome is defined by in-hospital mortality, prolonged ventilation (exceeding seven days), or acute kidney injury requiring dialysis.
Measured: 30 days from the day of surgery.
Secondary outcomes (1)
One-year mortality
One-year is defined as 365 days from the day of surgery.
Measured: 365 days from the day of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start10 Mar 2020
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 547 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Providence Healthcare, Montreal Heart Institute, Auckland City Hospital, Melbourne Health
- Responsible party
- Sponsor
- Investigators
- Jane Heggie, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787705
- Sponsor's protocol ID
- 18-5588
- Status last verified
- Feb 2024
- First submitted
- 2 Mar 2021
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Model of Preoperative Predictors of Outcome for Adults Undergoing Congenital Cardiac Surgery: Multicenter Model Validation
- ClinicalTrials.gov ID
- NCT04787705
- Acronym / sponsor ID
- 18-5588
- Conditions
- Adult Congenital Heart Disease, Cardiac Surgery
- Keywords
- Prediction model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 547 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Providence Healthcare, Montreal Heart Institute, Auckland City Hospital, Melbourne Health
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All ACHD patients undergoing cardiac surgery in TGH and the other collaborating cardiac centers.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
One-year mortality
Time frame: 365 days from the day of surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
Related trials for Adult Congenital Heart Disease
RecruitingPhase 1/2
An AAV Gene Therapy Trial of AFTX-201 in Adults With BAG3-Associated Dilated Cardiomyopathy (DCM)
Dilated Cardiomyopathy (DCM), BAG3 Mutation Associated Dilated Cardiomyopathy
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Aim 3: Pilot Study of a Serious Game to Promote Transition Readiness Skills
Serious Games, Transition-age Youth
RecruitingObservational study
Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation
Exocrine Pancreatic Insuficiency
Not yet recruiting
Optimizing Care Transitions in CHD
Congenital Heart Disease (CHD), Mentorship
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Heggie, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Congenital Heart Disease and Cardiac Surgery, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite adverse events (time frame: 30 days from the day of surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.