Coronary angiography in patients with known coronary artery disease
Conditions
Interventions
Product Name: Visipaque 320
Pharmaceutical Form: Injection*
INN or Proposed INN: Iodixanol
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 652-
Produ
Sponsors
University Hospital of Frankfurt, Department of Cardiology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients must be older than 18 y.o. - Written consent to the study - Coronary angiography is required for medical reasons - Calculated glomerular filtration rate = 60 ml/min (calculation is based on the shortened MDRD-formula) - Severe heart failure, diagnosed either by an ejection fraction = 45 % (echocardiography) or a clinical condition NYHA III or IV Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Severe comorbidity (i.e. neoplasia, life expectaning = 2 yrs.) - Intravacular administration of iodinated contrast dye within last 14 days - Intake of nephrotoxic drugs within the last 7 days - Intake of metformine within the last 24 hours - Patients with prior renal transplantation - End-stage renal disease or acute renal failure and/or necessity of dialysis after coronary angiography - Pregnancy or lactation - Impaired liver function following the Child-Pugh criteria according a severity level of Child B or C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: An important side effect of iodinated contrast medium is the CM nephrotoxicity (RCMN). Incidence in renal healthy patients is rated 5%,in patients with renal risk factors 20-30%.As independent renal risk factors are defined: Renal impairment, diabetes mellitus, heart failure, hypertension, peripheral vascular disease and a volume of contrast medium > 260 ml. The risk of a RCMN rises with the cumulation of risk factors. A doubleblind study in 2003 showed that using Iodixanol (nonionic, dimer, isoosmolar) in patients with renal impairment and diabetes mellitus undergoing coronary or aortofemoral angiography leads to a significant lower rise of the serum creatinine compared to Ioversol (non-ionic, monomer, lowosmolar). This study examines if there is as well a significant difference in nephrotoxic effects between Iodixanol and Ioversol in high-risk patients with renal impairment and severe heart failure who often still have other renal risk factors as diabetes mellitus or hypertension.;Secondary Objective: None;Primary end point(s): Increase of serum creatinine = 0,5 mg/dl on day 1, 3 or 7 after administration of contrast dye | — |
Countries
Germany
Outcome results
None listed