Ameliorating Contrast Induced Nephropathy After Coronary Angiography

July 10, 2024 updated by: Sarah Sabry Hashem, Ain Shams University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo
      • Heliopolis, Cairo, Egypt, 11355
        • The Cardiovascular Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24-48 hours after PCI

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum Creatinine (S.Cr) level
Time Frame: 48 hours after PCI
48 hours after PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

November 15, 2023

First Submitted That Met QC Criteria

November 15, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

July 11, 2024

Last Update Submitted That Met QC Criteria

July 10, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23 (SIME)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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