Clinical trial NCT06139952: Ameliorating Contrast Induced Nephropathy After Coronary Angiography
Official title: Assessment of the Effect of Atorvastatin and N-acetyl Cysteine on Prevention of Contrast Induced Nephropathy in Patients Undergoing Coronary Angiography CIN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Nephropathy; Toxic, Drugs
Keywords: Contrast Induced Nephropathy
Percutaneous Coronary Intervention
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective single blinded multi armed randomized controlled clinical trial
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Contrast induced nephropathy (CIN) incidence
timeFrame: 24-48 hours after PCI
Secondary outcomes:
measure: Serum Creatinine (S.Cr) level
timeFrame: 48 hours after PCI
Other outcomes:
Locations:
city: Heliopolis
country: Egypt
facility: The Cardiovascular Hospital
state: Cairo
Study officials:
References:
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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.
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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.
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.