Ameliorating Contrast Induced Nephropathy After Coronary Angiography

NCT06139952 | Completed Phase 4

• 1 other identifier: 23
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Nephropathy; Toxic, Drugs

Keywords

Contrast Induced Nephropathy; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• Contrast induced nephropathy (CIN) incidence

  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 Outcomes (1)

• Serum Creatinine (S.Cr) level

  48 hours after PCI

Study Arms (3)

High-dose Atorvastatin group

EXPERIMENTAL

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

Drug: Atorvastatin 80mg

N-acetyl cysteine group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

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

Interventions

Atorvastatin 80mg DRUG

Atorvastatin 80mg taken Once before coronary angiography

Control group; High-dose Atorvastatin group

N-acetyl cysteine DRUG

200mg 3 times daily 2 days before coronary angiography

Control group; N-acetyl cysteine group

Normal Saline OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

The Cardiovascular Hospital

Heliopolis, Cairo Governorate, 11355, Egypt

Location

Related Publications (5)

• Yang Y, Song M, Liu Y, Liu H, Sun L, Peng Y, Liu F, Venkatachalam MA, Dong Z. Renoprotective approaches and strategies in acute kidney injury. Pharmacol Ther. 2016 Jul;163:58-73. doi: 10.1016/j.pharmthera.2016.03.015. Epub 2016 Apr 22.

  PMID: 27108948 BACKGROUND

• van der Molen AJ, Reimer P, Dekkers IA, Bongartz G, Bellin MF, Bertolotto M, Clement O, Heinz-Peer G, Stacul F, Webb JAW, Thomsen HS. Post-contrast acute kidney injury. Part 2: risk stratification, role of hydration and other prophylactic measures, patients taking metformin and chronic dialysis patients : Recommendations for updated ESUR Contrast Medium Safety Committee guidelines. Eur Radiol. 2018 Jul;28(7):2856-2869. doi: 10.1007/s00330-017-5247-4. Epub 2018 Feb 7.

  PMID: 29417249 BACKGROUND

• Chong E, Poh KK, Lu Q, Zhang JJ, Tan N, Hou XM, Ong HY, Azan A, Chen SL, Chen JY, Ali RM, Fang WY, Lau TW, Tan HC. Comparison of combination therapy of high-dose oral N-acetylcysteine and intravenous sodium bicarbonate hydration with individual therapies in the reduction of Contrast-induced Nephropathy during Cardiac Catheterisation and Percutaneous Coronary Intervention (CONTRAST): A multi-centre, randomised, controlled trial. Int J Cardiol. 2015 Dec 15;201:237-42. doi: 10.1016/j.ijcard.2015.07.108. Epub 2015 Aug 5.

  PMID: 26301645 BACKGROUND

• Ma WQ, Zhao Y, Wang Y, Han XQ, Zhu Y, Liu NF. Comparative efficacy of pharmacological interventions for contrast-induced nephropathy prevention after coronary angiography: a network meta-analysis from randomized trials. Int Urol Nephrol. 2018 Jun;50(6):1085-1095. doi: 10.1007/s11255-018-1814-0. Epub 2018 Feb 5.

  PMID: 29404930 BACKGROUND

• Xie W, Liang X, Lin Z, Liu M, Ling Z. Latest Clinical Evidence About Effect of Acetylcysteine on Preventing Contrast-Induced Nephropathy in Patients Undergoing Angiography: A Meta-Analysis. Angiology. 2021 Feb;72(2):105-121. doi: 10.1177/0003319720950162. Epub 2020 Aug 24.

  PMID: 32830526 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Kidney Diseases

Interventions

Atorvastatin; Acetylcysteine; Saline Solution

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacist

Model Details: A prospective single blinded multi armed randomized controlled clinical trial

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 18, 2023
• Study Start: December 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)