Ameliorating Contrast Induced Nephropathy After Coronary Angiography

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease; Nephropathy; Toxic, Drugs

Treatments: Drug: Atorvastatin 80mg; Drug: N-acetyl cysteine; Other: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06139952

23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 3 patient groups

High-dose Atorvastatin group

Experimental group

Description:

40 patients will receive 80 mg Atorvastatin before coronary angiography and will receive adequate hydration using (1ml/kg/hr)

Treatment:

Drug: Atorvastatin 80mg

N-acetyl cysteine group

Experimental group

Description:

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)

Treatment:

Drug: N-acetyl cysteine

Control group

Active Comparator group

Description:

40 patients will receive adequate hydration using (1ml/kg/hr)

Treatment:

Other: Normal Saline

Drug: N-acetyl cysteine

Drug: Atorvastatin 80mg