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OpenTrials
Completed

NCT Number: NCT06139952

Ameliorating Contrast Induced Nephropathy After Coronary Angiography

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atorvastatin 80mg

Drug

Atorvastatin 80mg taken Once before coronary angiography

N-acetyl cysteine

Drug

200mg 3 times daily 2 days before coronary angiography

Normal Saline

Other

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

Primary outcomes

  1. Contrast induced nephropathy (CIN) incidence

    Time frame: 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 outcomes

  1. Serum Creatinine (S.Cr) level

    Time frame: 48 hours after PCI

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2023
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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