Study Stopped
slow enrollment
Kidney Damage In Patients With Severe Fall In 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 Severe Fall in eGFR Undergoing Percutaneous Coronary Intervention With IOPAMIDOL Injection 370 or IODIXANOL 320
1 other identifier
interventional
15
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 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 2, 2010
CompletedFirst Posted
Study publicly available on registry
June 4, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
January 14, 2014
CompletedMarch 17, 2014
February 1, 2014
2 years
June 2, 2010
November 25, 2013
February 20, 2014
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 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
Study Arms (2)
IOPAMIDOL injection 370
ACTIVE COMPARATORIodixanol 320
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
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 unstable renal function
- Has a history of hypersensitivity to iodinated contrast agents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institu De Cardiologie De Montreal
Montreal, Quebec, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Maria Luigia Storto, M.D.
- Organization
- 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 2, 2010
First Posted
June 4, 2010
Study Start
November 1, 2010
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
March 17, 2014
Results First Posted
January 14, 2014
Record last verified: 2014-02