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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01136915
Other study ID # IOP-118
Secondary ID
Status Terminated
Phase Phase 4
First received June 2, 2010
Last updated February 20, 2014
Start date November 2010
Est. completion date November 2012

Study information

Verified date February 2014
Source Bracco Diagnostics, Inc
Contact n/a
Is FDA regulated No
Health authority China: Ethics CommitteeCanada: Health Canada
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 15
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Drug:
Iopamidol 370
one time administration for PCI
Iodixanol 320
Iodixanol 320 single injection for percutaneous coronary injection

Locations

Country Name City State
Canada Institu De Cardiologie De Montreal Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Bracco Diagnostics, Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic, Low-osmolar Contrast Media in Comparison to a Non-ionic, Iso-osmolar Contrast Media. Mean change from baseline values for serum NGAL at 2,4,6,24,48, and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of contrast media. Baseline and 2,4,6,24, 48, and 72 hours post-dose Yes
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