Kidney Damage in Patients With Normal eGFR

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT01137786
First received: June 3, 2010
Last updated: August 7, 2013
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Coronary Artery Stenosis
Drug: Non ionic contrast media comparator
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 Normal 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. [ 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 non-ionic low osmolar contrast media.


Enrollment: 49
Study Start Date: December 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IOPAMIDOL 370 Drug: Non ionic contrast media comparator
One time administration for PCI
Other Name: Isovue 370
Active Comparator: IODIXANOL 320 Drug: Non ionic contrast media comparator
one time administration for PCI
Other Name: Visipaque 320

  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 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
  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: NCT01137786

Locations
United States, Illinois
Prairie Cardiovascular Consultants, Ltd.
Springfield, Illinois, United States, 62701
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
Study Director: Maria Luigia Storto, MD Bracco Diagnostics, Inc
  More Information

No publications provided

Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT01137786     History of Changes
Other Study ID Numbers: IOP-116
Study First Received: June 3, 2010
Results First Received: May 22, 2013
Last Updated: August 7, 2013
Health Authority: Italy: Ethics Committee
United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Stenosis
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 21, 2014