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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01252810
Recruitment Status : Completed
First Posted : December 3, 2010
Results First Posted : May 2, 2014
Last Update Posted : May 15, 2014
i3 Statprobe
Medpace, Inc.
Biomedical Systems
Rules-Based Medicine, Inc.
Information provided by (Responsible Party):
GE Healthcare

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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

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
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 
Withdrawal by Subject                4                1 
Lost to Follow-up                0                1 
Physician Decision                2                1 
Various reasons                8                0 

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[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 
[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.
[Units: Participants]
Female   48   53   101 
Male   89   88   177 
Region of Enrollment 
[Units: Participants]
United States   128   134   262 
Canada   9   7   16 

  Outcome Measures

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

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

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

Responsible Party: GE Healthcare Identifier: NCT01252810     History of Changes
Other Study ID Numbers: GE 145-002
First Submitted: December 1, 2010
First Posted: December 3, 2010
Results First Submitted: February 6, 2014
Results First Posted: May 2, 2014
Last Update Posted: May 15, 2014