NITRATE-OCT-CIN Substudy
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled study investigating the effects of dietary nitrate on vascular function, platelet reactivity and restenosis in stable angina: Contrast Induced Nephropathy Sub-study
IRAS ID
194338
Contact name
Daniel Jones
Contact email
Sponsor organisation
Queen Mary University of London
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
In this project, we will determine whether a once daily inorganic nitrate administration (in the form of beetroot juice) might favourably reduce the incidence of kidney injury that occurs after balloon angioplasty and stent insertion. Kidney injury after balloon angioplasty and stent insertion also known as contrast induced nephropathy (CIN) is due to the administration of contrast (dye) during the procedure. It is the third most common cause of hospital-acquired kidney failure and although it is more than 70 years since the first description of a patient dying from kidney damage following the use of radiographic contrast media, it still represents a major and unmet clinical challenge, as this potential complication is associated with a prolonged hospitalization stay, a higher hospitalization cost, and a significant increase in morbidity and mortality. Data suggests that contrast dye may cause kidney damage by reducing levels nitric oxide (NO) within the kidneys. Since nitrates increase NO, these findings suggest a potential therapeutic benefit for the use of nitrates in the prevention of CIN. We therefore propose to evaluate the effects of nitrate administration on the incidence of CIN in patients undergoing balloon angioplasty and stent insertion. We think that Sodium Nitrite is protective for the kidney and will reduce the incidence of CIN. This study will have patients in two groups (one will have the active ingredient of nitrate in the beetroot juice and the other will be a placebo group with juice without nitrate). We plan to measure the levels of kidney function before the angioplasty procedure, 2 days afterwards and at 6 months to see if nitrate therapy makes a difference.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
17/SC/0017
Date of REC Opinion
11 Jan 2017
REC opinion
Favourable Opinion