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An open, prospective, randomized, comparative study to evaluate the effect of Iodixanol 320 compared to Iomeprol 350 on contrast medium induced nephropathy in patients with impaired renal function undergoing percutaneous coronary intervention - CONTRAST

An open, prospective, randomized, comparative study to evaluate the effect of Iodixanol 320 compared to Iomeprol 350 on contrast medium induced nephropathy in patients with impaired renal function undergoing percutaneous coronary intervention - CONTRAST

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-003832-24-DE
Enrollment
900
Registered
2006-04-18
Start date
2006-07-10
Completion date
Unknown
Last updated
2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with symptomatic coronary artery disease, impaired renal function (GFR<60ml/min) undergoing percutaneous coronary intervention

Interventions

Trade Name: VISIPAQUE 320 Product Name: Iodixanol Pharmaceutical Form: Solution for injection INN or Proposed INN: Iodixanol CAS Number: 92339-11-2 Other descriptive name: VISIPAQUE 320 Concentration

Sponsors

Deutsches Herzzentrum München
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Patients with a clinical indication for performing a diagnostic and/or interventional heart catheterization including a coronary angiography. -Presence of chronic renal failure as defined by impaired glomerular filtration rate (GFR;=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Age <18 years -Cardiogenic shock -Dialysis -Prior kidney transplantation -Concurrent intake of nephrotoxic medication (e.g., non-steroidal antiphlogistics, aminoglycosides) -Contra-indications for the use of iodixanol and iomeprol -Parenteral (i.v. or i.a.) administration of iodine-containing contrast medium either 7 days before or after the catheter intervention -Presumed or demonstrated pregnancy -Patient's inability to fully cooperate with the study protocol -Prior participation to this study

Design outcomes

Primary

MeasureTime frame
Main Objective: This study will compare the incidence of contrast medium induced nephropathy (CIN) after a percutaneous coronary intervention in patients with impaired renal function receiving either the conventional hyperosmolar contrast medium Iomeprol 350 or the isoosmolar contast medium Iodixanol 320.;Secondary Objective: -Reassessment of primary end point at 6 months after the percutaneous coronary intervention -Cardiovascular events within 12 months (death, myocardial infarction) -Mortality within 12 months -Duration of hospitalization -Incidence of severe acute kidney failure ;Primary end point(s): The primary endpoint is CIN during primary hospitalization for coronary angioplasty. CIN is defined an increase of serum-creatinine following exposure to contrast medium. This definition adheres to commonly accepted criteria.—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026