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Kidney Damage in Patients With Normal eGFR

NCT ID: NCT01137786

Last Updated: 2013-09-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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IOPAMIDOL 370

Group Type ACTIVE_COMPARATOR

Non ionic contrast media comparator

Intervention Type DRUG

One time administration for PCI

IODIXANOL 320

Group Type ACTIVE_COMPARATOR

Non ionic contrast media comparator

Intervention Type DRUG

one time administration for PCI

Interventions

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Non ionic contrast media comparator

One time administration for PCI

Intervention Type DRUG

Non ionic contrast media comparator

one time administration for PCI

Intervention Type DRUG

Other Intervention Names

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Isovue 370 Visipaque 320

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bracco Diagnostics, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Luigia Storto, MD

Role: STUDY_DIRECTOR

Bracco Diagnostics, Inc

Locations

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Prairie Cardiovascular Consultants, Ltd.

Springfield, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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IOP-116

Identifier Type: -

Identifier Source: org_study_id