CONNECT Trial - V3

• Research type

  Research Study

• Full title

  TITLE: A randomised factorial trial of N-acetylcysteine prophylaxis and iso-osmolar versus low-osmolar contrast media on kidney function in patients at risk of contrast induced nephropathy following cardiac catheterisation for percutaneous coronary interventions - the “CONNECT” trial.

• IRAS ID

  16021

• Contact name

  Periaswamy Velavan

• Sponsor organisation

  Liverpool Heart and Chest Hospital

• Eudract number

  2009-011175-70

• ISRCTN Number

  21422/0001/001-0001

• Research summary

  Approximately one third of patients referred for coronary angiography and percutaneous coronary intervention (PCI), the widely used method of treating angina and heart attacks, are known to have pre-existing kidney disease. These patients experience an increased rate of adverse outcomes including severe kidney failure and death after the procedure. This is mainly related to the development of deterioration in kidney function after the procedure in the short term (Contrast Induced Nephropathy - CIN) and possibly in the long term. A number of methods of preventing CIN after coronary angiogram and PCI have been investigated. These include hydration with intravenoufluds or sodium bicarbonate, use of various medications such as N-Acetyl cysteine (NAC), a scavenger of free radicals known to be toxic substances for kidney cells. Various types of contrast media such as low osmolar (current standard practice) and iso-osmolar media have also been tried. Except hydration witfluds, no other method has been proved to be beneficial without doubt and whether iso-osmolar contrast (IOC) is better than currently used low osmolar contrast (LOC) remains controversial due to conflicting scientific evidence. We therefore propose to investigate whether the combination of NAC and iso-osmolar contrast is more useful in maintaining baseline kidney function 6 months after the procedure and preventing major adverse cardiovascular events (MACE). All patients will be hydrated witfluds and will be randomised to 4 groups (NAC⃠, no NAC IOC, NAC LOC and no NAC LOC). Kidney function will be checked by a simple blood test (eGFR) at 6 months and incidence of MACE recorded.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  09/H1002/73

• Date of REC Opinion

  3 Nov 2009

• REC opinion

  Further Information Favourable Opinion