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Outcome Monitoring after Cardiac Procedure in Congenital Heart Disease

  • Research type

    Research Study

  • Full title

    Outcome Monitoring and Risk Stratification after Cardiac Procedure in Neonates, Infants, Children and Young Adults born with Congenital Heart Disease - Children OMACp

  • IRAS ID

    261397

  • Contact name

    Massimo Caputo

  • Contact email

    m.caputo@bristol.ac.uk

  • Sponsor organisation

    University Hospital Bristol NHS foundation Trust

  • Duration of Study in the UK

    5 years, 0 months, 1 days

  • Research summary

    Our ability to advance the medical care of patients with congenital heart disease (CHD) depends on our ability to access data generated and collected during normal clinical care. For this purpose, we propose to compile a data registry of CHD patients undergoing surgery and/or catheterisation, bringing together routinely collected clinical data: surgical and diagnostic, Paediatric Intensive Care Unit (PICU), HeartSuite, Hospital episode statistics (HES), Health electronic records (HER), imaging) as well as collecting biomaterials both from patients and their biological mothers (blood, urine and waste tissue when available).

    Patients will be identified from the cardiac catheter and surgical waiting lists at the Bristol Royal Hospital for Children (BRHC). Consenting participants who will be undergoing surgery will be asked to provide blood and urine samples at 3 time points (during the operation, immediately after the operation and at 24 hrs post intervention) through lines that are put in place routinely. They will be asked to donate waste tissue where appropriate. Consenting catheter patients will be asked to provide one blood and one urine sample during the catheter procedure through routinely inserted lines. All patients or their parents on their behalf in the case of younger participants will be asked to complete a short quality of life questionnaire before the procedure and at 3 and 12 months post procedure. Participants will be given a choice to complete the questionnaire electronically or via post.

    In addition, we would like to invite the biological mother of the study child to contribute one blood and one urine sample, as well as to consent to the study collating information regarding risk factors from relevant sections of their medical notes and by completing a questionnaire.

  • REC name

    South West - Cornwall & Plymouth Research Ethics Committee

  • REC reference

    19/SW/0113

  • Date of REC Opinion

    31 Jul 2019

  • REC opinion

    Further Information Favourable Opinion

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