Outcome monitoring after cardiac procedure in congenital heart disease

Outcome monitoring and risk stratification after cardiac procedure in neonates, infants, children and young adults born with congenital heart disease

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN17650644

Enrollment

6000

Registered

2019-07-01

Start date

2019-09-01

Completion date

Unknown

Last updated

2024-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital heart disease Circulatory System

Interventions

This study aims to develop a CHD data registry of patients undergoing surgery and/or catheterisation. The researchers propose to obtain consent from participants to add routinely collected clinical da

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 31/05/2024: Patients: 'Children (0-15 years old) or young adults (16 – 18 years of age), with CHD undergoing surgery and/or catheterisation OR having repeat surgery having been included in one of the groups mentioned above Mothers: Biological mother of a child enrolled in Children OMACp ______ Previous inclusion criteria: Patients: Children (0-15 years old) or young adults (16 – 18 years of age), with CHD undergoing surgery and/or catheterisation Mothers: Biological mother of a child enrolled in Children OMACp

Exclusion criteria

Exclusion criteria: 1. Unable to give informed consent and/or assent 2. Main residence is outside the UK 3. Under the care of Social Services

Design outcomes

Primary

Measure	Time frame
1. Aggregated routinely collected clinical data from review of medical notes: operation/catheterisation, PICU, HeartSuite, Hospital episode statistics (HES), HER, Magnetic Resonance Imaging (MRI), Computerised tomography (CT), Echocardiogram (ECHO). Assessed at baseline and then yearly for 5 years (with the option to extend to 10 years if further funding becomes available) 2. Phenotypic and genetic analysis of biomaterials that would normally be discarded during cardiac surgery (e.g. pericardial fluid, pieces of heart tissue and vessel removed during the operation) as well as blood and urine samples from patients and their biological mothers. Bio-samples will be stored long-term in the Bristol Biomedical Laboratory in preparation for future analyses by the children OMACp study or other ethically approved studies. Mothers and catheter patients: baseline blood and urine samples; surgery patients: baseline blood, urine and tissue when available, on arrival to PICU: blood and urine samples, 24 hours post-surgery: blood and urine samples	—

Measure

Time frame

1. Aggregated routinely collected clinical data from review of medical notes: operation/catheterisation, PICU, HeartSuite, Hospital episode statistics (HES), HER, Magnetic Resonance Imaging (MRI), Computerised tomography (CT), Echocardiogram (ECHO). Assessed at baseline and then yearly for 5 years (with the option to extend to 10 years if further funding becomes available) 2. Phenotypic and genetic analysis of biomaterials that would normally be discarded during cardiac surgery (e.g. pericardial fluid, pieces of heart tissue and vessel removed during the operation) as well as blood and urine samples from patients and their biological mothers. Bio-samples will be stored long-term in the Bristol Biomedical Laboratory in preparation for future analyses by the children OMACp study or other ethically approved studies. Mothers and catheter patients: baseline blood and urine samples; surgery patients: baseline blood, urine and tissue when available, on arrival to PICU: blood and urine samples, 24 hours post-surgery: blood and urine samples

—

Secondary

Measure	Time frame
1. Short, medium and long-term clinical outcomes in patients born with CHD undergoing cardiac surgery or catheter intervention, monitored by reviewing the patient’s medical notes yearly for 5 years (with the option to extend to 10 years if further funding becomes available) 2. NHS resource use, monitored by reviewing the patient’s medical notes yearly for 5 years (with the option to extend to 10 years if further funding becomes available) 3. Demographics collected via questionnaires at baseline 4. Patient’s quality of Life (QoL) measured using KIDSCREEN/EQ5D-Y at baseline, 3 months and 12 months post-procedure 5. Maternal demographics and information on potentially modifiable risk factors associated with CHD, assessed using questionnaire developed specifically for this study and accessing relevant pregnancy medical records at baseline 6. Genetic and phenotypical characterisation of patients and their mothers 7. MicroRNA analyses and isolation of progenitor cells when sufficient tissue, plasma and serum are available	—

Measure

Time frame

1. Short, medium and long-term clinical outcomes in patients born with CHD undergoing cardiac surgery or catheter intervention, monitored by reviewing the patient’s medical notes yearly for 5 years (with the option to extend to 10 years if further funding becomes available) 2. NHS resource use, monitored by reviewing the patient’s medical notes yearly for 5 years (with the option to extend to 10 years if further funding becomes available) 3. Demographics collected via questionnaires at baseline 4. Patient’s quality of Life (QoL) measured using KIDSCREEN/EQ5D-Y at baseline, 3 months and 12 months post-procedure 5. Maternal demographics and information on potentially modifiable risk factors associated with CHD, assessed using questionnaire developed specifically for this study and accessing relevant pregnancy medical records at baseline 6. Genetic and phenotypical characterisation of patients and their mothers 7. MicroRNA analyses and isolation of progenitor cells when sufficient tissue, plasma and serum are available

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 8, 2026