Mobilisation of endothelial progenitor cells and statin therapy PILOT

  • Research type

    Research Study

  • Full title

    Mobilisation of endothelial progenitor cells by statin therapy in patients with coronary disease: a proof of concept pilot study.

  • IRAS ID

    164407

  • Contact name

    Dr Rob Butler

  • Contact email

    rob.butler@uhns.nhs.uk

  • Sponsor organisation

    University Hospitals of North Midlands NHS Trust

  • Eudract number

    2015-000273-13

  • Duration of Study in the UK

    0 years, 3 months, 1 days

  • Research summary

    In total 20 patient participants will be investigated within our pilot study, divided into 2 sub-groups of 10 patient participants each. The first group will comprise of 10 participants of recent onset angina, the second group will comprise of 10 participants admitted into our coronary care unit and have a positive blood test called troponin that suggest a cardiac event the so called acute coronary syndrome (ACS) group. We envisage that the new onset angina participants will be statin naive and will be started on atorvastatin 20mg. However ACS participants can be either statin naive or if already on statin therapy reloaded with atorvastatin 80mg as per current standard of care. Participant enrolment will be at rapid access chest pain clinic for identification newly diagnosed angina patients or in the case of ACS participants from within our coronary care unit (CCU). The participants will have blood test at baseline, day 0 then on days 1,3,7 and 28 to measure levels of endothelial progenitor cells (EPC). There will be 2 blood samples taken at the same time on day 1, one sample will be stored at 40C the other at room temperature. Small aliquots from each tube will be immediately, and then at 2, 6, 9 and 12 hours, if sample remain stable at 12 hours we will also test samples at 24 hours for EPC levels. This will allow the identification of the optimal time after venesection and temperature to analysis the samples. Therefore this proof of concept pilot study will firstly confirm that our current analysing technique, flow cytometry assays, allows identification and quantification of EPC in patients with cardiovascular disease on statin therapy. Secondly, to assess for time and temperature stability of our blood samples.

  • REC name

    West Midlands - Edgbaston Research Ethics Committee

  • REC reference

    15/WM/0111

  • Date of REC Opinion

    26 Mar 2015

  • REC opinion

    Favourable Opinion