Kidney Damage in Patients With Normal eGFR
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
1 other identifier
interventional
49
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2010
CompletedFirst Posted
Study publicly available on registry
June 4, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
September 30, 2013
CompletedSeptember 30, 2013
April 1, 2012
1.3 years
June 3, 2010
May 22, 2013
August 7, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low 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 non-ionic low osmolar contrast media.
Baseline and 2, 4, 6, 24, 48, and 72 hours post-dose
Study Arms (2)
IOPAMIDOL 370
ACTIVE COMPARATORIODIXANOL 320
ACTIVE COMPARATORInterventions
One time administration for PCI
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prairie Cardiovascular Consultants, Ltd.
Springfield, Illinois, 62701, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Maria Luigia Storto, M.D.
- Organization
- Bracco Diagnostics Inc.
Study Officials
- STUDY DIRECTOR
Maria Luigia Storto, MD
Bracco Diagnostics, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2010
First Posted
June 4, 2010
Study Start
December 1, 2010
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
September 30, 2013
Results First Posted
September 30, 2013
Record last verified: 2012-04