Impact of ATOrvastatin REload on the Prevention of Contrast-INduced Nephropathy in patients on Chronic Statin Therapy: A prospective randomized trial (ATORE-CIN)

Phase 3

• Conditions: renal diseases

• Registration Number: PACTR202110707328144
• Lead Sponsor: hedi chaker hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-16
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

This is a prospective, randomized, single-blind, controlled trial, implemented in all consecutive patients (older than 18 years), undergoing coronary angiography or percutaneous coronary intervention in our department between June 2020 and September 2020 and who had already been receiving atorvastatin for at least one week, before admission.

Exclusion Criteria

*patients admitted because of an acute coronary syndrome in whom a loading dose is recommended according to guidelines,
*statin-naïve patients,
*patients who received a statin other than atorvastatin before the procedure,
*patients already receiving 80 mg atorvastatin, patients requiring dialysis and those with eGFR less than 15 ml/min/ 1.73 m2,
*patients who were exposed to a contrast medium within 7 days, patients with an allergy to contrast media,
*patients with cardiogenic shock or severe cardiac insufficiency (left ventricular ejection fraction LVEF <20%),
*patients with severe liver damage, malignant tumor, infectious disease, or fever,
*and those who refused to consent.
* patients who didn't return to get control laboratory tests

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the incidence of Cys-based CIN defined as an increase in serum CyC concentration by 10% above the baseline value 24 hours after contrast media<br>administration (17) and the incidence of SCr-based CIN defined as the increase in SCr the concentration of 44.2 mmol/L or 25% above baseline within 72 hours after exposure to contrast<br>media.

Secondary Outcome Measures

Name	Time	Method
The secondary end-point was to detect any acute kidney injury by a significant rise in cystatin<br>C level between baseline and 24 hours in the two groups ( AR and NR groups).<br>We assessed the risk of CIN before the procedure using the Mehran score (20). The risk of CIN<br>was considered low if Mehran’s score =0-5, moderate if Mehran’s score=6-10, High if<br>Mehran’s score>10.