Ameliorating Contrast Induced Nephropathy After Coronary Angiography

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-07-01

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.

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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.

Conditions

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Coronary Artery Disease Nephropathy; Toxic, Drugs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective single blinded multi armed randomized controlled clinical trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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High-dose Atorvastatin group

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

Group Type EXPERIMENTAL

Atorvastatin 80mg

Intervention Type DRUG

Atorvastatin 80mg taken Once before coronary angiography

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)

Group Type EXPERIMENTAL

N-acetyl cysteine

Intervention Type DRUG

200mg 3 times daily 2 days before coronary angiography

Control group

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

Group Type ACTIVE_COMPARATOR

Atorvastatin 80mg

Intervention Type DRUG

Atorvastatin 80mg taken Once before coronary angiography

N-acetyl cysteine

Intervention Type DRUG

200mg 3 times daily 2 days before coronary angiography

Normal Saline

Intervention Type OTHER

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

Interventions

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Atorvastatin 80mg

Atorvastatin 80mg taken Once before coronary angiography

Intervention Type DRUG

N-acetyl cysteine

200mg 3 times daily 2 days before coronary angiography

Intervention Type DRUG

Normal Saline

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

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No