Congenital Heart Disease (CHD)NCT02303535
National Congenital Heart Disease Audit
An observational study of Congenital Heart Disease (CHD), run by University College, London at 10 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Heart Disease (CHD)
- What is being tested?
- Cardiac Surgery and Therapeutic cardiac catheterisations procedures
- Type of treatment
- Surgery or procedure
- How many people
- 120,000 participants
- Where
- 10 sitesUnited Kingdom
- Study dates
- Apr 2000to Mar 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All potential patients are assessed through a systematic process of clinical evaluation, diagnostic assessment. Patient selection is effected in each individual unit through a multidisciplinary team process. These teams consist not only of cardiac surgeons and interventional cardiologists but also of many other medical specialties and allied professionals. The decision as to the access route to be used is determined by the multidisciplinary team.
Who may be able to join
- Patient, judged by multidisciplinary team meeting as unsuitable for the procedure
Who cannot join
- Patient, judged by multidisciplinary team meeting, as unsuitable for the procedure
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United Kingdom10 sites, 10 recruiting
- Recruiting
Royal Victoria Hospital Belfast
Belfast, Northern Ireland, BT12 6BA
- Recruiting
Queen Elizabeth Hospital (Edgbaston)
Birmingham
- Recruiting
Leeds General Infirmary
Leeds, West Yorkshire, LS1 3EX
- Recruiting
Alder Hey Hospital
Liverpool, Merseyside, L12 2AP
- Recruiting
Royal Brompton Hospital
London, London, SW3 6NP
- Recruiting
The Harley Street Clinic
London, London, W1G 8BJ
- Recruiting
The Heart Hospital
London
- Recruiting
Freeman Hospital
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
- Recruiting
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
- Recruiting
Southampton General Hospital
Southampton, Hampshire, SO16 6YD
About this study
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.
Read more
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:
http://www.ucl.ac.uk/nicor/audits/congenital/datasets
Read the detailed description
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
Data collection:
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.
Data quality:
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 linkage:
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.
Information governance:
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.
- Conditions
- Congenital Heart Disease (CHD)
- Being tested
- Cardiac Surgery, Therapeutic cardiac catheterisations procedures
- Keywords
- Congenital heart disease, European Paediatric Cardiac Code Short List, Specific Procedure Definitions, OPCS, paediatric, pediatric
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac SurgeryProcedure or surgery
Also called Norwood procedure (Stage 1), Heart Transplant, TAPVD Repair + Arterial Shunt, Fontan procedure
All patients with congential and acquired heart disease treated by cardiac surgery procedures.
Therapeutic cardiac catheterisations proceduresProcedure or surgery
Also called Transcatheter PVR, VSD closure (catheter), Aortic balloon valvotomy, Coarctation angioplasty
All patients with congential and acquired heart disease treated by therapeutic cardiac catheterisations procedures .
| Study group | Role | What they receive |
|---|---|---|
| Congenital | 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. Receives: Procedure: Cardiac Surgery; Procedure: Therapeutic cardiac catheterisations procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day survival rates
The analysis shows the national survival rates at 30 days for each procedure and the national survival rates for individual procedures by age.
Measured: 30 day survival from operation date
Secondary outcomes (1)
1 year survival rates
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.
Measured: 1 year survival rates after the date of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startApr 2000
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart Disease (CHD)Studies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- 120,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Society for Cardiothoracic Surgery in Great Britain & Ireland, British Congenital Cardiac Association
- Responsible party
- Sponsor
- Investigators
- Rodney Franklin, MD, Study chair, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303535
- Sponsor's protocol ID
- NICOR-CONGENITAL
- Status last verified
- Oct 2016
- First submitted
- 25 Nov 2014
- Last updated
- 4 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pagel C, Utley M, Crowe S, Witter T, Anderson D, Samson R, McLean A, Banks V, Tsang V, Brown K. Real time monitoring of risk-adjusted paediatric cardiac surgery outcomes using variable life-adjusted display: implementation in three UK centres. Heart. 2013 Oct;99(19):1445-50. doi: 10.1136/heartjnl-2013-303671. Epub 2013 Apr 5.
PubMed 23564473
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Congenital Heart Disease Audit
- ClinicalTrials.gov ID
- NCT02303535
- Acronym / sponsor ID
- NICOR-CONGENITAL
- Conditions
- Congenital Heart Disease (CHD)
- Keywords
- Congenital heart disease, European Paediatric Cardiac Code Short List, Specific Procedure Definitions, OPCS, paediatric, pediatric
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120,000 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Society for Cardiothoracic Surgery in Great Britain & Ireland, British Congenital Cardiac Association
- Study start
- Apr 2000
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 1 Dec 2014 (estimated)
- 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.
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:
http://www.ucl.ac.uk/nicor/audits/congenital/datasets
Detailed description
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
Data collection:
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.
Data quality:
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 linkage:
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.
Information governance:
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Congenital | – | Procedure: Cardiac Surgery, Procedure: Therapeutic cardiac catheterisations proceduresAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All potential patients are assessed through a systematic process of clinical evaluation, diagnostic assessment. Patient selection is effected in each individual unit through a multidisciplinary team process. These teams consist not only of cardiac surgeons and interventional cardiologists but also of many other medical specialties and allied professionals. The decision as to the access route to be used is determined by the multidisciplinary team.
Key inclusion criteria (1 listed)
- Patient, judged by multidisciplinary team meeting as unsuitable for the procedure
Key exclusion criteria (1 listed)
- Patient, judged by multidisciplinary team meeting, as unsuitable for the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac SurgeryAlso: Norwood procedure (Stage 1), Heart Transplant, TAPVD Repair + Arterial Shunt, Fontan procedureAll patients with congential and acquired heart disease treated by cardiac surgery procedures. | Procedure or surgery | Congenital |
| Therapeutic cardiac catheterisations proceduresAlso: Transcatheter PVR, VSD closure (catheter), Aortic balloon valvotomy, Coarctation angioplastyAll patients with congential and acquired heart disease treated by therapeutic cardiac catheterisations procedures . | Procedure or surgery | Congenital |
Primary outcome
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 secondary outcome
1 year survival rates
Time frame: 1 year survival rates after the date of the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
- Background: PubMed 23564473Pagel C, Utley M, Crowe S, Witter T, Anderson D, Samson R, McLean A, Banks V, Tsang V, Brown K. Real time monitoring of risk-adjusted paediatric cardiac surgery outcomes using variable life-adjusted display: implementation in three UK centres. Heart. 2013 Oct;99(19):1445-50. doi: 10.1136/heartjnl-2013-303671. Epub 2013 Apr 5.
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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.
Rodney Franklin, MD study chair
Royal Brompton & Harefield NHS Foundation Trust
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease (CHD), run by University College, London at 10 sites in United Kingdom.
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 1 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 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom. 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?
Contact James CHAL, MHlthMgmnt (0203 549 5621, nicor-ics@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 day survival rates (time frame: 30 day survival from operation date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02303535, which also lists 1 linked publication.
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 4 Nov 2016.