Evaluation of the oral Nicorandil effect on reducing the contrast-induced nephropathy incidence in cardiac catheterization patients: a randomized controlled clinical trial

Determination of the effect of Nicorandil in the prevention of contrast-induced nephropathy in patients with at least two risk factors for contrast nephropathy

The envelope method will be used for random allocation in this study. 344 small cards are placed in a large envelope, from 1 to 344 is written on the cards. Numbers 1 to 172 will belong to the Nicorandil group and numbers 173 to 344 will belong to the control group.

This study is a randomized controlled and open-labeled clinical trial performed in the angiography department of Imam Reza Hospital. Eligible patients are divided into control and intervention groups (nicorandil) using a list of random numbers.

Admission requirements: based on score risk. Renal failure GFR (less than 60) Serum creatinine baseline above 1.5 mg/dl and no pregnancy. Minimum age 18. Diabetes mellitus. EF less than 40. Conditions of non-entry: pregnancy. Pulmonary edema. Cardiogenic shock. Multiple myeloma. Acute renal failure. ESRD (GFR <15mg / dl). Allergy to media contrast. Allergy to nicorandil. Meeting with media contrast in the last 7 days. And mannitol and phenol dopamine in the last 48 hours

In the intervention group from 2 hours before to 24 to 48 hours after the procedure, oral nicorandil 10 mg 3 times a day, and intravenous normal saline from 2 hours before to 6 hours after the procedure is given to patients. In the control group, intravenous normal saline (1 ml/kg/hr) is given to patients from 2 hours before to 6 hours after the procedure.

Laboratory parameters such as Hb, FBS, HCT, TG, LDL, HDL, ChoL as well as creatinine and creatinine clearance and BUN

This is how the envelopes will be prepared and printed by one of the research team members, and random numbers with the help of the Randomaize.com site will be placed inside the envelope. The lid of the envelope will be closed and its contents will not be visible from the outside. Then, the purpose of the study is first explained to the person who meets the conditions, and the person, if desired, signs the informed consent form and takes an envelope, and then opens it and enters the intervention or control group based on the contents of the envelope.

The subjects and those evaluating the outcome will be unaware of the intervention and control groups. Eligible patients are divided into control and intervention groups (nicorandil) using a list of random numbers. Those who evaluate the outcome consist of people who work at the center and have no knowledge of the researchers' research and will make a secret assignment for the research themselves.