Coronary Artery Disease, Nephropathy; Toxic, Drugs
Conditions
Keywords
Contrast Induced Nephropathy, Percutaneous Coronary Intervention
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.
Interventions
DRUGAtorvastatin 80mg
Atorvastatin 80mg taken Once before coronary angiography
DRUGN-acetyl cysteine
200mg 3 times daily 2 days before coronary angiography
OTHERNormal Saline
adequate hydration using Normal Saline (1ml/kg/hr)
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
A prospective single blinded multi armed randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Serum Creatinine (S.Cr) level | 48 hours after PCI |
Countries
Egypt
Outcome results
None listed