Kidney Damage In Patients With Severe Fall In eGFR

This study has been terminated.
(slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT01136915
First received: June 2, 2010
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Coronary Artery Stenosis
Drug: Iopamidol 370
Drug: Iodixanol 320
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Phase IV Pilot Study to Evaluate Kidney Damage Measured by Neutrophil Gelatinase-Associated Lipocalin (NGAL) as a New Bio-Marker in Patients With Severe Fall in eGFR Undergoing Percutaneous Coronary Intervention With IOPAMIDOL Injection 370 or IODIXANOL 320

Resource links provided by NLM:


Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • 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. [ Time Frame: Baseline and 2,4,6,24, 48, and 72 hours post-dose ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 15
Study Start Date: November 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IOPAMIDOL injection 370 Drug: Iopamidol 370
one time administration for PCI
Other Name: Isovue 370
Active Comparator: Iodixanol 320 Drug: Iodixanol 320
Iodixanol 320 single injection for percutaneous coronary injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136915

Locations
Canada, Quebec
Institu De Cardiologie De Montreal
Montreal, Quebec, Canada
Sponsors and Collaborators
Bracco Diagnostics, Inc
  More Information

No publications provided

Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT01136915     History of Changes
Other Study ID Numbers: IOP-118
Study First Received: June 2, 2010
Results First Received: November 25, 2013
Last Updated: February 20, 2014
Health Authority: China: Ethics Committee
Canada: Health Canada

Additional relevant MeSH terms:
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014