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Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure

This study has been completed.
Sponsor:
Collaborators:
i3 Statprobe
Medpace, Inc.
Biomedical Systems
Rules-Based Medicine (RBM)
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01252810
First received: December 1, 2010
Last updated: May 1, 2014
Last verified: May 2014
Results First Received: February 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Diagnostic
Condition: Cardio Renal Safety in High-risk Elderly Subjects Undergoing a Coronary CATH With or Without PCI.
Intervention: Drug: GE-145

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ioforminol 320mg I/ml Injection Ioforminol 320 mg I/mL as a single iv. administration.
Iopamidol 370mg I/ml Injection Iopamidol 370 mg I/mL as a single iv. administration.

Participant Flow:   Overall Study
    Ioforminol 320mg I/ml Injection     Iopamidol 370mg I/ml Injection  
STARTED     142     142  
COMPLETED     128     139  
NOT COMPLETED     14     3  
Withdrawal by Subject                 4                 1  
Lost to Follow-up                 0                 1  
Physician Decision                 2                 1  
Various reasons                 8                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Ioforminol 320mg I/ml Injection Ioforminol 320 mg I/mL as a single iv. administration.
Iopamidol 370mg I/ml Injection Iopamidol 370 mg I/mL as a single iv. administration.
Total Total of all reporting groups

Baseline Measures
    Ioforminol 320mg I/ml Injection     Iopamidol 370mg I/ml Injection     Total  
Number of Participants  
[units: participants]
  137     141     278  
Age [1]
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     28     30     58  
>=65 years     109     111     220  
Gender  
[units: participants]
     
Female     48     53     101  
Male     89     88     177  
Region of Enrollment  
[units: participants]
     
United States     128     134     262  
Canada     9     7     16  
[1] Per a Protocol Amendment, A-01, the minimum age changed to male or female greater than or equal to 18 years of age who have a history of chronic renal insufficiently.



  Outcome Measures
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1.  Primary:   Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader.   [ Time Frame: After the imaging date for either Ioforminol or Iopamidol. ]

2.  Secondary:   To Determine Incidence Rates of the Overall AEs, Organ-specific AEs (i.e., Delayed Skin Reactions, General Subject Comfort, and Allergic/Immunologic Reactions, Etc.) and SAEs Following Administration   [ Time Frame: Time zero equals the date of contrast imaging and for up to 7 days for safety monitoring post contrast administration. ]

3.  Secondary:   Assessing the Incidence of Renal Biomarker-based Contrast-induced Acute Kidney Injury (CI-AKI) in Subjects Post Administration of Ioforminol or Iopamidol Injections   [ Time Frame: 2, 6 and 24 hours post Ioforminol and Iopamidol adminstration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ruben Sheng, M.D.
Organization: GE Healthcare
phone: 609-514-6899
e-mail: Rubin.Sheng@ge.com


No publications provided


Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01252810     History of Changes
Other Study ID Numbers: GE 145-002
Study First Received: December 1, 2010
Results First Received: February 6, 2014
Last Updated: May 1, 2014
Health Authority: United States: Food and Drug Administration