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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Iodixanol
Iopamidol
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014