Kidney Damage In Patients With Severe Fall In eGFR

NCT ID: NCT01136915

Last Updated: 2014-03-17

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-11-30

Brief Summary

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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.

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 injection 370

Group Type ACTIVE_COMPARATOR

Iopamidol 370

Intervention Type DRUG

one time administration for PCI

Iodixanol 320

Group Type ACTIVE_COMPARATOR

Iodixanol 320

Intervention Type DRUG

Iodixanol 320 single injection for percutaneous coronary injection

Interventions

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Iopamidol 370

one time administration for PCI

Intervention Type DRUG

Iodixanol 320

Iodixanol 320 single injection for percutaneous coronary injection

Intervention Type DRUG

Other Intervention Names

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Isovue 370

Eligibility Criteria

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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
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

Locations

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Institu De Cardiologie De Montreal

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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IOP-118

Identifier Type: -

Identifier Source: org_study_id

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