Public Notice – Outcomes of Drug Coated Balloon Angioplasty, A UK Real Life Experience from 2009 to 2015 (DCBNORWICH).
DCBNORWICH study is a proposed registry to assess outcomes of patients who have received angioplasty treatment with a novel device called a drug coated balloon during the aforementioned period and compare them with the outcomes of patients treated with drug eluting stents. Norfolk and Norwich University Hospital (NNUH) is the leading hospital in the UK performing these procedures and has been recognized as a center of expertise for this type of treatment.
The study involves retrieving clinical outcomes from the National Institute of Cardiac Outcomes Research (NICOR) which collects patient data of all angioplasty procedures, coronary artery bypass graft surgeries and heart attacks from all NHS hospitals. In order to track the outcomes, patient identifiable data such as the NHS number, DOB and gender will be shared with the NICOR. It is proposed to report outcomes until 2031 making this a study with a very long term follow up period. Patient identifiable data will be accessed only by hospital doctors/direct care team members and the NICOR. In a very small number of patients, identifiable information will be shared with a member of the direct care team of another hospital if they have received angioplasty outside Norfolk and Norwich Hospital on a later date. No identifiable data will be published nor divulged to any other party.
All relevant approvals such as Caldicott guardian of the hospital, National Research Ethics Committee and Health Research Authority (HRA) approval were obtained prior to commencement of the study. The HRA advised seeking approval from the Confidentiality Advisory Group (CAG) which has been obtained. The CAG provides a recommendation to the Health Research Authority (HRA) as appointed decision-maker for research applications. The HRA has given Section 251 support for the activity following advice from the CAG.
This will be one of the largest registries published on this domain once completed and will be invaluable in further advancements of the field.
A patient group meeting has been held to obtain patient views and a patient is in the study steering committee to oversee adherence to guidelines as well as to make sure patient interests are met.
If you are a patient who has received drug coated balloon angioplasty treatment at the NNUH during the above mentioned period and if you have any objection to your data being used in the above manner please do get in touch with us using any of the below mentioned contact portals.
Amendment: A proposal has been approved to acquire patient outcomes through the NHS Digital for patients treated till 15th November 2019 (patient follow up has been approved until 23rd December 2031). This amendment will increase significantly the robustness and significance of the results. This proposal has been approved by all of the above mentioned bodies. If you have been treated either with a drug coated balloon or a drug eluting stent and have any objection to your data being used as described above please do get in touch.
Dr Rajkumar Natarajan, Clinical research fellow, NNUH (Rajkumar.firstname.lastname@example.org)
Dr Natasha Corballis, Clinical research fellow, NNUH (email@example.com)
Dr Ioannis Merinopoulos, Clinical Research Fellow, NNUH (Ioannis.firstname.lastname@example.org)
Dr Vassilios Vassiliou, Clinical Senior Lecturer and Honorary Consultant Cardiology, NNUH and Norwich Medical School (email@example.com)
Dr Simon Eccleshall, Consultant Cardiologist, NNUH – Chief Investigator (firstname.lastname@example.org)
Research and Development, Norfolk and Norwich University Hospital NHS Foundation Trust, Colney Lane, NR4 7UY. Telephone 01603 287062 or email Office.RD@nnuh.nhs.uk