Ameliorating Contrast Induced Nephropathy After Coronary Angiography
- Conditions
- Coronary Artery DiseaseNephropathy; Toxic, Drugs
- Interventions
- Registration Number
- NCT06139952
- Lead Sponsor
- Ain Shams University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High-dose Atorvastatin group Atorvastatin 80mg 40 patients will receive 80 mg Atorvastatin before coronary angiography and will receive adequate hydration using (1ml/kg/hr) Control group N-acetyl cysteine 40 patients will receive adequate hydration using (1ml/kg/hr) N-acetyl cysteine group N-acetyl cysteine 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 Atorvastatin 80mg 40 patients will receive adequate hydration using (1ml/kg/hr) Control group Normal Saline 40 patients will receive adequate hydration using (1ml/kg/hr)
- Primary Outcome Measures
Name Time Method Contrast induced nephropathy (CIN) incidence 24-48 hours after PCI 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
- Secondary Outcome Measures
Name Time Method Serum Creatinine (S.Cr) level 48 hours after PCI
Trial Locations
- Locations (1)
The Cardiovascular Hospital
🇪🇬Heliopolis, Cairo, Egypt