Ameliorating Contrast Induced Nephropathy After Coronary Angiography

Coronary Artery Disease Clinical Trial

Official title:

Assessment of the Effect of Atorvastatin and N-acetyl Cysteine on Prevention of Contrast Induced Nephropathy in Patients Undergoing Coronary Angiography CIN

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06139952
• Other study ID #: 23
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: November 2023
• Source: Ain Shams University
• Contact: Sarah Sabry, PhD
• Phone: 00201068289698
• Email: sarah.sabry16[@]pharma.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Given the limited understanding of the impact of statin and N-acetyl cysteine use before angiography in preventing contrast-induced nephropathy (CIN), the objective of this study is to evaluate the effectiveness of atorvastatin in preventing CIN among patients undergoing coronary angiography.

Description:

A multi armed randomized controlled clinical trial to be conducted from June 2023.According to inclusion and exclusion criteria, All patients presenting to the Cardiology department at Ain Shams University hospitals, will be assessed for eligibility. At least 120 patients subjected to elective CT coronary angiography who are at risk of developing contrast-induced renal failure will be enrolled. The participants will be assigned to Three groups (40 patients for each group):

• Three groups

• High-dose Atorvastatin group: 40 patients will receive 80 mg Atorvastatin before coronary angiography and will receive adequate hydration using (1ml/kg/hr)

• N-acetyl cysteine group: 40 patients will receive 200mg 3 times daily 2 days before coronary angiography and 2 days after and will receive adequate hydration using (1ml/kg/hr)

• Control group: 40 patients will receive adequate hydration using (1ml/kg/hr) The blood sample will be collected from all patients before the administration of contrast media and after 24 hours for assessment of the needed parameters.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Undergoing elective Coronary angiography who will receive coronary angiography contrast media.

• Must have at least two consecutive serum creatinine measurements (Before and after Contrast exposure)

Exclusion Criteria:

• Pregnant or lactating women

• Patients with Serum creatinine conc of >2.1 mg/Dl

• Patients undergoing emergency primary percutaneous coronary intervention for ST-segment elevation myocardial infarction.

• Prior exposure to contrast media within 7 days

• Contraindication for a high-dose statin, N-acetyl Cysteine prescription

Related Conditions & MeSH terms

• Coronary Artery Disease
• Kidney Diseases

Intervention

Drug:
• Atorvastatin 80mg
Atorvastatin 80mg taken Once before coronary angiography
• N-acetyl cysteine
200mg 3 times daily 2 days before coronary angiography

Other:
• Normal Saline
adequate hydration using Normal Saline (1ml/kg/hr)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

References & Publications (5)

Chong E, Poh KK, Lu Q, Zhang JJ, Tan N, Hou XM, Ong HY, Azan A, Chen SL, Chen JY, Ali RM, Fang WY, Lau TW, Tan HC. Comparison of combination therapy of high-dose oral N-acetylcysteine and intravenous sodium bicarbonate hydration with individual therapies in the reduction of Contrast-induced Nephropathy during Cardiac Catheterisation and Percutaneous Coronary Intervention (CONTRAST): A multi-centre, randomised, controlled trial. Int J Cardiol. 2015 Dec 15;201:237-42. doi: 10.1016/j.ijcard.2015.07.108. Epub 2015 Aug 5. — View Citation

Ma WQ, Zhao Y, Wang Y, Han XQ, Zhu Y, Liu NF. Comparative efficacy of pharmacological interventions for contrast-induced nephropathy prevention after coronary angiography: a network meta-analysis from randomized trials. Int Urol Nephrol. 2018 Jun;50(6):1085-1095. doi: 10.1007/s11255-018-1814-0. Epub 2018 Feb 5. — View Citation

van der Molen AJ, Reimer P, Dekkers IA, Bongartz G, Bellin MF, Bertolotto M, Clement O, Heinz-Peer G, Stacul F, Webb JAW, Thomsen HS. Post-contrast acute kidney injury. Part 2: risk stratification, role of hydration and other prophylactic measures, patients taking metformin and chronic dialysis patients : Recommendations for updated ESUR Contrast Medium Safety Committee guidelines. Eur Radiol. 2018 Jul;28(7):2856-2869. doi: 10.1007/s00330-017-5247-4. Epub 2018 Feb 7. — View Citation

Xie W, Liang X, Lin Z, Liu M, Ling Z. Latest Clinical Evidence About Effect of Acetylcysteine on Preventing Contrast-Induced Nephropathy in Patients Undergoing Angiography: A Meta-Analysis. Angiology. 2021 Feb;72(2):105-121. doi: 10.1177/0003319720950162. Epub 2020 Aug 24. — View Citation

Yang Y, Song M, Liu Y, Liu H, Sun L, Peng Y, Liu F, Venkatachalam MA, Dong Z. Renoprotective approaches and strategies in acute kidney injury. Pharmacol Ther. 2016 Jul;163:58-73. doi: 10.1016/j.pharmthera.2016.03.015. Epub 2016 Apr 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast induced nephropathy (CIN) incidence	Contrast-induced nephropathy was defined as an absolute increase of 0.5 mg/dL or a relative increase of >25% in creatinine levels 24-48 hours after the procedure.; Contrast-induced nephropathy was defined as an absolute increase of 0.5 mg/dL or a relative increase of >25% in creatinine levels 24-48 hours after the procedure.; Contrast-induced nephropathy was defined as an absolute increase of 0.5 mg/dL or a relative increase of >25% in creatinine levels 24-48 hours after the procedure.; Contrast-induced nephropathy was defined as an absolute increase of 0.5 mg/dL or a relative increase of >25% in creatinine levels 24-48 hours after the procedure.; Contrast-induced nephropathy was defined as an absolute increase of 0.5 mg/dL or a relative increase of >25% in creatinine levels	24-48 hours after PCI
Secondary	Serum Creatinine (S.Cr) level		48 hours after PCI