Ameliorating Contrast Induced Nephropathy After Coronary Angiography

Sponsor

Ain Shams University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06139952

Collaborator

(none)

120

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Nephropathy; Toxic, Drugs	Drug: Atorvastatin 80mg Drug: N-acetyl cysteine Other: Normal Saline	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A prospective single blinded multi armed randomized controlled clinical trialA prospective single blinded multi armed randomized controlled clinical trial

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: High-dose Atorvastatin group

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

Drug: Atorvastatin 80mg

Atorvastatin 80mg taken Once before coronary angiography

Experimental: 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)

Drug: N-acetyl cysteine

200mg 3 times daily 2 days before coronary angiography

Active Comparator: Control group

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

Drug: Atorvastatin 80mg

Atorvastatin 80mg taken Once before coronary angiography

Drug: N-acetyl cysteine

200mg 3 times daily 2 days before coronary angiography

Other: Normal Saline

adequate hydration using Normal Saline (1ml/kg/hr)

Outcome Measures

Primary Outcome Measures

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

Serum Creatinine (S.Cr) level [48 hours after PCI]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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