subjects with mild to moderate renal impairment (SCr =1.5-2.5 mg/dL and/or calculated CrCl = 10-60 mL/min) who undergo clinically-indicated IV contrast-enhanced MDCTA scanning of the lower extremity arterial system
Conditions
Sponsors
Bracco Imaging S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: provide written Informed Consent and are willing to comply with protocol requirements 18 years of age or older, have a stable* baseline serum creatinine level of SCr=1.5-2.5 mg/dL and/or calculated CrCl = 10-60 mL/min. *2 stable values: one within 6 months and one within 2 weeks before the examination, referred for a clinically-indicated contrast-enhanced MDCTA examination of the lower extremity arterial system. 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: •· determined, by their physicians, that prophylactic medication is medically required for them to receive intravascular administration of an iodinated contrast agent, · a history of hypersensitivity to iodine-containing compounds,· severe congestive heart failure (class III-IV NYHA), · suspicion of hyperthyroidism or thyroid malignancies, · undergone any other radiological procedure utilizing x-ray contrast media from 72 hours before to 7 days after the administration of the study agent, · uncontrolled diabetes, · dialysis, · unstable renal function/ serum creatinine levels/ acute renal failure, · is a pregnant or lactating female. Exclude the possibility of pregnancy:- by testing on site at the institution (serum or urine ßHCG) within 24 hours prior to the start of study agent administration - by history (eg, tubal ligation or hysterectomy)- post menopausal with a minimum 1 year without menses (time of pregnancy test in relation to study agent administration must be recorded); · previously entered in this study or having received an investigational drug within 30 days prior to admission to this study, · any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data or achieving the study objectives, i.e.:- drug dependence,- psychiatric disorders, dementia, or other reasons for expected poor compliance with investigator’s instructions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ·To quantitatively compare the efficacy of enhancement of key arteries in subjects with mild to moderate renal impairment (SCr =1.5-2.5 mg/dL and/or calculated CrCl = 10-60 mL/min) who undergo clinically-indicated IV contrast-enhanced MDCTA scanning of the lower extremity arterial system with equi-iodine doses of one of two contrast agents, Iomeron®-400 or Visipaque™-320.;Secondary Objective: · To qualitatively compare the efficacy of enhancement in subjects, both overall and at a segmental/regional level, with mild to moderate renal impairment (SCr=1.5-2.5 mg/dL and/or calculated CrCl = 10-60 mL/min) who undergo clinically-indicated IV contrast-enhanced MDCTA scanning of the lower extremity arterial system with equi-iodine doses of one of two contrast agents, Iomeron®-400 or Visipaque™-320.· To compare between the two study agents the incidence of contrast-induced nephropathy (CIN), defined as a >0.5 mg/dL post-CT scan increase in serum creatinine at 48-72 hours post-dose vs pre-dose value.· To compare between the two study agents the incidence of delayed (2 hours to 7 days post-administration) hypersensitivity-type cutaneous/subcutaneous adverse reactions. ;Primary end point(s): To quantitatively compare the efficacy of enhancement of key arteries during IV contrast-enhanced MDCTA scanning of the lower extremity arterial system with equi-iodine doses of one of two contrast agents, Iomeron®-400 or Visipaque™-320.Since all intravascular blood has approximately the same un-enhanced CT density, all values of intravascular enhancement will be measured, recorded and analyzed as absolute Hounsfield units as measured after contrast administration.The quantitative measurements of maximum CT density in HU, after contrast administration will be measured in six regions of interest: suprarenal abdominal aorta, infrarenal abdominal aorta, common iliac arteries, external iliac/common femoral arteries, superficial femoral arteries, popliteal arteries. Quantitati | — |
Countries
Austria, Italy, Sweden, United Kingdom
Outcome results
None listed