Kidney Damage in Patients With Normal eGFR

Bracco

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Stenosis

Treatments: Drug: Non ionic contrast media comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT01137786

IOP-116

Details and patient eligibility

About

This is a pilot study, randomized, double-blind, parallel group comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have normal eGFR. Statistical summaries will be presented to analyse the various laboratory tests for the two groups.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provides written Informed Consent and is willing to comply with protocol requirements;
• Is at least 18 years of age;
• Is scheduled to undergo a percutaneous coronary intervention and/or diagnostic coronary angiography.
• Has documented estimated glomerular filtration rate [eGFR] ≥60 mL/min/1.73 m2 calculated with the MDRD formula within 72 hours prior to enrollment.

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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49 participants in 2 patient groups

IOPAMIDOL 370

Active Comparator group

Treatment:

Drug: Non ionic contrast media comparator

Drug: Non ionic contrast media comparator

IODIXANOL 320

Active Comparator group

Treatment:

Drug: Non ionic contrast media comparator

Drug: Non ionic contrast media comparator