Ameliorating Contrast Induced Nephropathy After Coronary Angiography

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Artery Disease, Nephropathy; Toxic, Drugs

Intervention / Treatment
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* Drug: Atorvastatin 80mg
* Drug: N-acetyl cysteine
* Other: Normal Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective single blinded multi armed randomized controlled clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-dose Atorvastatin group<br>40 patients will receive 80 mg Atorvastatin before coronary angiography and will receive adequate hydration using (1ml/kg/hr) | Drug: Atorvastatin 80mg<br>* Atorvastatin 80mg taken Once before coronary angiography<br>|
| Experimental: N-acetyl cysteine group<br>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) | Drug: N-acetyl cysteine<br>* 200mg 3 times daily 2 days before coronary angiography<br>|
| Active Comparator: Control group<br>40 patients will receive adequate hydration using (1ml/kg/hr) | Drug: Atorvastatin 80mg<br>* Atorvastatin 80mg taken Once before coronary angiography<br>Drug: N-acetyl cysteine<br>* 200mg 3 times daily 2 days before coronary angiography<br>Other: Normal Saline<br>* adequate hydration using Normal Saline (1ml/kg/hr)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Creatinine (S.Cr) level |  | 48 hours after PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contrast Induced Nephropathy, Percutaneous Coronary Intervention