National Congenital Heart Disease Audit
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02303535|
Recruitment Status : Unknown
Verified October 2016 by University College, London.
Recruitment status was: Recruiting
First Posted : December 1, 2014
Last Update Posted : November 4, 2016
The National Institute of Cardiovascular Outcomes Research (NICOR) collects data and produces analysis to enable hospitals and healthcare improvement bodies to monitor and improve the quality of care and outcomes of cardiovascular patients.
The Congenital Heart Disease audit collects data on all cardiac surgery and therapeutic cardiac catheterisations procedures used to treat patients with congenital and acquired heart disease.
For acquired heart disease, the audit covers all arrhythmias & cardiomyopathies in patients less than 16 years old only. For congenital heart disease, the audit collects data on both children and adult patients. The audit covers all specialist centers in the UK and Republic of Ireland.
The project aims to improve the quality of care for children and adults with congenital heart disease by providing national comparative analysis of procedure specific activity and outcomes of cardiac surgery and therapeutic cardiac catheterisation procedures. The audit also provides quality indicators for the antenatal detection of major congenital heart disease.
The current dataset is available from here:
|Condition or disease||Intervention/treatment|
|Congenital Heart Disease (CHD)||Procedure: Cardiac Surgery Procedure: Therapeutic cardiac catheterisations procedures|
The Congenital Heart Disease audit collects data on all cardiac surgery and therapeutic cardiac catheterisations procedures used to treat patients with congenital and acquired heart disease
Hospitals use Patient Administration Systems and manual data entry by cardiac database managers to submit data to NICOR.
Data are either assimilated locally using third party commercial software and imported as a .csv file, or entered directly onto the NICOR database.
NICOR provide tools that communicate possible errors to centres submitting data. A data submitting schedule has been agreed with the centres, data is submitted and a validation report is returned each quarter. Centres are responsible for updating errors in the records.
An import log highlights missing and invalid data as well as records that failed to import due to data quality or compatibility issues.
In addition, data is validated by on site visits with a NICOR representative.
Data is annually linked with Office fot National Statistics (ONS) life status and Hospital Episodes Statistics (HES) admission data to verify case ascertainment and to track long term outcome measures.
NICOR has Section 251 approval and data protection registration. An organisation-wide standard operating procedure is in place for Information Security Incident Management. University College London has a robust information governance framework, to which NICOR adheres.
|Study Type :||Observational|
|Estimated Enrollment :||120000 participants|
|Official Title:||National Congenital Heart Disease Audit|
|Study Start Date :||April 2000|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||March 2017|
All patients with congential and acquired heart disease treated by cardiac surgery and therapeutic cardiac catheterisations procedures .
For acquired heart disease, the audit covers all arrhythmias & cardiomyopathies in patients less than 16 years old only.
For congenital heart disease, the audit collects data on both children and adult patients.
Procedure: Cardiac Surgery
All patients with congential and acquired heart disease treated by cardiac surgery procedures.
Procedure: Therapeutic cardiac catheterisations procedures
All patients with congential and acquired heart disease treated by therapeutic cardiac catheterisations procedures .
- 30 day survival rates [ Time Frame: 30 day survival from operation date ]The analysis shows the national survival rates at 30 days for each procedure and the national survival rates for individual procedures by age.
- 1 year survival rates [ Time Frame: 1 year survival rates after the date of the procedure ]Analysis include 1-year outcome but a death would not appear in the table until a full year has passed for the whole cohort of patients within that year. For example, the audit collection period is based on financial year of April 1st to March 31st. A patient that died in April would be reported within the same period as one that died 11 months later in March.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02303535
|Contact: James CHAL, MHlthMgmnt||0203 549 email@example.com|
|Southampton General Hospital||Recruiting|
|Southampton, Hampshire, United Kingdom, SO16 6YD|
|Alder Hey Hospital||Recruiting|
|Liverpool, Merseyside, United Kingdom, L12 2AP|
|Royal Victoria Hospital Belfast||Recruiting|
|Belfast, Northern Ireland, United Kingdom, BT12 6BA|
|John Radcliffe Hospital||Recruiting|
|Oxford, Oxfordshire, United Kingdom, OX3 9DU|
|Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN|
|Leeds General Infirmary||Recruiting|
|Leeds, West Yorkshire, United Kingdom, LS1 3EX|
|Queen Elizabeth Hospital (Edgbaston)||Recruiting|
|Birmingham, United Kingdom|
|Royal Brompton Hospital||Recruiting|
|London, United Kingdom, SW3 6NP|
|The Harley Street Clinic||Recruiting|
|London, United Kingdom, W1G 8BJ|
|The Heart Hospital||Recruiting|
|London, United Kingdom|
|Study Chair:||Rodney Franklin, MD||Royal Brompton & Harefield NHS Foundation Trust|