Evaluation of Preventive Effect of Intravenous Trans Sodium Crocetinate on Contrast-Induced Nephropathy in Patients Undergoing Coronary Angioplasty : A randomized placebo-controlled triple-blind clinical trail

Determining effect of TSC in preventing ARF in patients undergoing elective coronary angioplasty

triple-blind randomized clinical trial. In this phase 2 trial with a sample size of 152 outpatients, angioplasty candidates and randomized by site www.randomization.com

152 outpatients are candidates for angioplasty based on inclusion and exclusion criteria. checklist is filled out for the patient. Group 1: Patients undergoing elective angioplasty , receive TSC before angioplasty in addition to the standard measure of preventing kidney damage, and then on days 0 to 5 of the patient intervention in the form of oral crocetin tablets at a dose of 7.5 mg TID for 5 days group 2: in addition, they receive placebo vials before angioplasty, in following 5 days, they take placebo tablets TID Blood, urinary and clinical factors are measured during the study

Inclusion : Patients 18 years and older who are candidates for non-emergency angioplasty GFR <60 ml / min before angioplasty Mehran score > 11 consent to study receiving ARB or ACEI with statins do not have more than 15% difference in serum creatinine during the last three days intravenous hydration at least 4 hours before angioplasty Do not require emergency angiography in the first 48 hours Have no history of acute renal failure in the last 6 months or kidney transplantation Exclusion : dialysis before angiography other diseases leading to ARF active tumor exposure to intravenous contrast agents in the last 14 days heart failure taking special drugs

control group receives standard interventions for ARF prevention, treatment group also receive TSC .

Primary outcome: effect of TSC on the occurrence of ARF Secondary outcome: Effect of TSC administration on ClCr, serum and BUN , cystatin C , Hs-CRP, 24-h urine, Mehran score, MDA

block randomization complete by using www.randomization.com. each block has 4 members defining as [AABB], [ABAB], [ABBA], [BABA], [BBAA], [BAAB]. Codes A and B are randomly assigned to the intervention groups and the control group. The aforementioned site selects 38 blocks at random from the four blocks so that 76 patients can be included in the study. patients will be assigned to one of the control groups according to the time of admission and at the beginning of admission according to the sequence obtained in the randomization stage. Interventions are allocated. These codes are not provided to the researcher present in the physician's office. Medications are also given to patient by number (A or B) and he is completely unaware of which drug or placebo is. The researcher's telephone number is also available for patients to call whenever any problem arises. (This researcher is not involved in prescribing or analyzing the data; however, he or she is solely responsible for evaluating and maintaining the codes and providing medication to patients based on a random code determined by the physician). The code assigned by him is recorded in the CRF form.

After the codes are prepared and given to the researcher, if the inclusion criteria are met and based on the codes, the patient is randomly placed in one of the groups. The relevant code is recorded in the CRF form and the researcher considers the drug or placebo based on the assigned code for the patient. After the patient is admitted to the hospital, the patient is introduced to a nurse and the medication is prescribed by the nurse (therapist). Knows only the assigned code, performs the relevant evaluations, and after registration, the results are given to the person who performs the data analysis, in the form of a code, and the data analysis is performed without the knowledge of the data analyzer. And all confidential information is recorded and stored without mentioning the patient's name. The vials of medicine and placebo, as well as the pills taken, have a similar shape.