The Grey-Zone FFR Study (GzFFR Study)

• Research type

  Research Study

• Full title

  A randomised controlled trial in stable intermediate coronary lesions and grey-zone FFR values with evaluation of the diagnostic utility of invasive coronary physiological indices and quantitative perfusion MRI.

• IRAS ID

  165552

• Contact name

  Barry Hennigan

• Contact email

  barryhennigan@gjnh.scot.nhs.uk

• Sponsor organisation

  Golden Jubilee National Hospital / National Waiting Times Board

• Duration of Study in the UK

  2 years, 11 months, 8 days

• Research summary

  The arteries that supply blood to the heart can become narrowed or stenosed resulting in chest pain or angina. When we perform an angiogram to assess these arteries sometime the pictures we see are inconclusive and we need to measure blood flow (indirectly) in order to determine the appropriate treatment. These blood flow measurements (FFR) have proven benefits in selecting those not requiring treatment as well as those most likely to benefit from treatment involving a procedure to open a heart artery blockage with insertion of a metal tube or stent into the artery (PCI). Not all of these measurements are reliable and a certain group of patients (grey-zone FFR) undergoing these measurements can have readings that are very difficult for their doctor to reliably interpret. In this study we will perform additional measurements to calculate blood flow using another similar wire that directly measures blood flow in the arteries. In addition we will perform MRI scans which provide detailed pictures of the heart, its blood supply as well as further MRI derived blood flow measurements. Following these measurements patients will be randomly allocated to stent insertion and medication or medication only without stent insertion and will be followed up for one year to assess their health. We hope to determine the best method for investigating and treating these individuals.

  Lay summary of study results:

  17 percent of patients with borderline reduced coronary blood flow results were found to have reduced blood supply to the heart muscle supplied by the artery under study as assessed by MRI.
  Patients randomly allocated to stenting had less symptoms of chest pain on short term followup than those treated with medicine alone. There was no significant difference in symptoms after 1 year of follow up

• REC name

  West of Scotland REC 4

• REC reference

  15/WS/0013

• Date of REC Opinion

  10 Mar 2015

• REC opinion

  Further Information Favourable Opinion