Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures
NCT ID: NCT04604418
Last Updated: 2025-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
10000 participants
OBSERVATIONAL
2020-10-01
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
However, the information provided by national databases lack granularity and the information from single institutional data is limited.
This project aims to address this knowledge gap in quantifying the risk for cardiac patients coming for noncardiac procedures and identify the health care resource utilization and system to best care for this patient population. To conduct this study, we will create a multi-institutional collaboration between large and small centers to create a unique dataset spanning all the different variables that need to be considered in risk prediction for these patients including patient variables, hospital setting, and providers. The aggregate multiinstitutional data set may be used for benchmarking for national quality improvement efforts.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Early Re-intervention in Infants and Small Children After Correction of Tetralogy of Fallot
NCT00536432
Resuscitation Registry in CHD
NCT05373498
Assessing the Hemodynamic Benefits of Cardiac Resynchronization Therapy in Children Following Open-Heart Surgery
NCT00397514
Outcomes in Patients and Their Closest Relatives Treated for Congenital Heart Disease With Catheter Based or Surgical Techniques
NCT01421030
Investigation of Tetralogy of Fallot in Neonates
NCT06822400
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No intervention. It is observational
No intervention. It is observational
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients diagnosed with congenital heart disease
3. Patients undergoing a noncardiac procedure (surgical or nonsurgical)
Exclusion Criteria
2. Patients with congenital heart disease undergoing a catheterization(diagnostic or interventional) or an electrophysiology study
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Hospital for Sick Children
OTHER
Vanderbilt University Medical Center
OTHER
University of Minnesota
OTHER
Children's Hospital of Philadelphia
OTHER
Children's Healthcare of Atlanta
OTHER
Baylor College of Medicine
OTHER
Children's National Research Institute
OTHER
Children's Hospital of The King's Daughters
OTHER
University of California, Los Angeles
OTHER
Boston Children's Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Viviane Nasr
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Viviane Nasr, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California, Los Angeles
Los Angeles, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Children's Healthcare of Atlanta - Egleston Hospita
Atlanta, Georgia, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Children's Hospital
Houston, Texas, United States
Children's Hospital of the King's Daughter
Norfolk, Virginia, United States
Hospital for Sick Kids
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Nina Deutsch, MD
Role: primary
Viviane Nasr, MD
Role: primary
Susan Nicolson
Role: primary
Wanda Miller Hance
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB-P00035008
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.