Kidney Damage In Patients With Severe Fall In eGFR

Bracco

Status and phase: Terminated; Phase 4

Conditions: Coronary Artery Stenosis

Treatments: Drug: Iopamidol 370; Drug: Iodixanol 320

Study type: Interventional

Funder types: Industry

Identifiers

NCT01136915

IOP-118

Details and patient eligibility

About

This is a pilot study using a randomized, double blinded, comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have and estimated glomerular filtration [eGFR] < 30 mL/min/1.73 m2. Statistical summaries will be presented to analyse the various laboratory tests for the two groups.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provides written Informed Consent
• Is at least 18 years of age;
• Is scheduled for or likely to undergo percutaneous coronary intervention;
• Has documented estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2 calculated with the MDRD formula within 72 hours prior the enrolment.

Exclusion criteria

• Is a pregnant or lactating female
• Has a history of severe congestive heart failure
• Has a history of hyperthyroidism
• Has unstable renal function
• Has a history of hypersensitivity to iodinated contrast agents

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

15 participants in 2 patient groups

IOPAMIDOL injection 370

Active Comparator group

Treatment:

Drug: Iopamidol 370

Iodixanol 320

Active Comparator group

Treatment:

Drug: Iodixanol 320