Trial Outcomes & Findings for Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure (NCT NCT01252810)

Last Updated: 2018-08-29

Results Overview

Overall image quality (excellent, adequate or poor) and diagnostic usefulness (diagnostic or non-diagnostic) were assessed using qualitative scales.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

284 participants

Primary outcome timeframe

After the imaging date for either Ioforminol or Iopamidol.

Results posted on

2018-08-29

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	142	142
Overall Study COMPLETED	128	139
Overall Study NOT COMPLETED	14	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	4	1
Overall Study Lost to Follow-up	0	1
Overall Study Physician Decision	2	1
Overall Study Various reasons	8	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ioforminol 320mg I/ml Injection n=137 Participants Ioforminol 320 mg I/mL as a single iv. administration.	Iopamidol 370mg I/ml Injection n=141 Participants Iopamidol 370 mg I/mL as a single iv. administration.	Total n=278 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=93 Participants	30 Participants n=4 Participants	58 Participants n=27 Participants
Age, Categorical >=65 years	109 Participants n=93 Participants	111 Participants n=4 Participants	220 Participants n=27 Participants
Sex: Female, Male Female	48 Participants n=93 Participants	53 Participants n=4 Participants	101 Participants n=27 Participants
Sex: Female, Male Male	89 Participants n=93 Participants	88 Participants n=4 Participants	177 Participants n=27 Participants
Region of Enrollment United States	128 participants n=93 Participants	134 participants n=4 Participants	262 participants n=27 Participants
Region of Enrollment Canada	9 participants n=93 Participants	7 participants n=4 Participants	16 participants n=27 Participants

PRIMARY outcome

Timeframe: After the imaging date for either Ioforminol or Iopamidol.

Population: The measured values are looking at 1) Overall Image Quality and, 2) Diagnostic Usefulness.

Overall image quality (excellent, adequate or poor) and diagnostic usefulness (diagnostic or non-diagnostic) were assessed using qualitative scales.

Outcome measures

Outcome measures
Measure	Ioforminol 320mg I/ml Injection n=137 Participants Ioforminol 320 mg I/mL as a single iv. administration.	Iopamidol 370mg I/ml Injection n=141 Participants Iopamidol 370 mg I/mL as a single iv. administration.
Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader. Overall Image Quality-Excellent	65 Number of subjects	71 Number of subjects
Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader. Overall Image Quality-Adequate	57 Number of subjects	59 Number of subjects
Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader. Overal Image Quality-Poor	15 Number of subjects	11 Number of subjects
Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader. Diagnostic Usefulness-Diagnostic	123 Number of subjects	134 Number of subjects
Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader. Diagnostic Usefulness-Non-Diagnostic	14 Number of subjects	7 Number of subjects

SECONDARY outcome

Timeframe: Time zero equals the date of contrast imaging and for up to 7 days for safety monitoring post contrast administration.

Population: Summary of Treatment-Emergent Adverse Events (TEAE) in greater than of equal to 2% of Subjects.

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 of GE-145 or iopamidol. To determine incidence rates and onset time of biomarker-based and SCr-based CI-AKI following administration of GE-145 or iopamidol. Summary of Treatment-Emergent Adverse Events (TEAE) in greater than of equal to 2% of Subjects.

Outcome measures

Outcome measures
Measure	Ioforminol 320mg I/ml Injection n=137 Participants Ioforminol 320 mg I/mL as a single iv. administration.	Iopamidol 370mg I/ml Injection n=141 Participants Iopamidol 370 mg I/mL as a single iv. administration.
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 Diarrhea	3 Number of events	1 Number of events
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 Nausea	3 Number of events	3 Number of events
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 Catheter-Site Hematoma	9 Number of events	8 Number of events
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 Catheter-Site Hemorrhage	4 Number of events	6 Number of events
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 Catheter-Site Pain	4 Number of events	3 Number of events
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 Chest Pain	3 Number of events	2 Number of events
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 Urinary Tract Infection	3 Number of events	4 Number of events
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 Blood Creatinine Increased	2 Number of events	4 Number of events
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 Pain In Extremity	2 Number of events	5 Number of events
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 Dizziness	0 Number of events	3 Number of events
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 Headache	11 Number of events	1 Number of events
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 Angina Pectoris	3 Number of events	2 Number of events
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 Coronary Artery Disease	3 Number of events	3 Number of events

SECONDARY outcome

Timeframe: 2, 6 and 24 hours post Ioforminol and Iopamidol adminstration

Population: Summary of subjects with renal biomarker-based CI-AKI by time point (Per Protocol Population).

Analyzing the number of subjects with renal biomarker-based contrast-induced acute kidney injury (CI-AKI).

Outcome measures

Outcome measures
Measure	Ioforminol 320mg I/ml Injection n=109 Participants Ioforminol 320 mg I/mL as a single iv. administration.	Iopamidol 370mg I/ml Injection n=106 Participants Iopamidol 370 mg I/mL as a single iv. administration.
Assessing the Incidence of Renal Biomarker-based Contrast-induced Acute Kidney Injury (CI-AKI) in Subjects Post Administration of Ioforminol or Iopamidol Injections Time- Post Contrast, 2 hours	24 Subjects	21 Subjects
Assessing the Incidence of Renal Biomarker-based Contrast-induced Acute Kidney Injury (CI-AKI) in Subjects Post Administration of Ioforminol or Iopamidol Injections Time- Post Contrast, 6 hours	48 Subjects	33 Subjects
Assessing the Incidence of Renal Biomarker-based Contrast-induced Acute Kidney Injury (CI-AKI) in Subjects Post Administration of Ioforminol or Iopamidol Injections Time- Post Contrast, 24 hourss	61 Subjects	49 Subjects

Adverse Events

Ioforminol 320mg I/ml Injection

Serious events: 13 serious events

Other events: 20 other events

Deaths: 0 deaths

Iopamidol 370mg I/ml Injection

Serious events: 10 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Ioforminol 320mg I/ml Injection n=137 participants at risk Ioforminol 320 mg I/mL as a single iv. administration. Up to 7 days post Iopamidol administration.	Iopamidol 370mg I/ml Injection n=141 participants at risk Iopamidol 370 mg I/mL as a single iv. administration. Up to 7 days post Ioforminol administration.
General disorders Catheter-Site Hemotoma	6.6% 9/137 • Number of events 9 • Up to 7 days post Ioforminol and Iopamidol administrations.	5.7% 8/141 • Number of events 8 • Up to 7 days post Ioforminol and Iopamidol administrations.
Nervous system disorders Headache	8.0% 11/137 • Number of events 11 • Up to 7 days post Ioforminol and Iopamidol administrations.	0.71% 1/141 • Number of events 1 • Up to 7 days post Ioforminol and Iopamidol administrations.

Additional Information

Ruben Sheng, M.D.

GE Healthcare

Phone: 609-514-6899

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Ioforminol 320mg I/ml Injection n=137 participants at risk Ioforminol 320 mg I/mL as a single iv. administration. Up to 7 days post Iopamidol administration.	Iopamidol 370mg I/ml Injection n=141 participants at risk Iopamidol 370 mg I/mL as a single iv. administration. Up to 7 days post Ioforminol administration.
Cardiac disorders Angina pectoris	0.73% 1/137 • Number of events 1 • Up to 7 days post Ioforminol and Iopamidol administrations.	0.71% 1/141 • Number of events 1 • Up to 7 days post Ioforminol and Iopamidol administrations.
Cardiac disorders Aortic stenosis	0.73% 1/137 • Number of events 1 • Up to 7 days post Ioforminol and Iopamidol administrations.	0.00% 0/141 • Up to 7 days post Ioforminol and Iopamidol administrations.
Cardiac disorders Atrial fibrillation	0.73% 1/137 • Number of events 1 • Up to 7 days post Ioforminol and Iopamidol administrations.	0.71% 1/141 • Number of events 1 • Up to 7 days post Ioforminol and Iopamidol administrations.
Cardiac disorders Cardiac failure	0.73% 1/137 • Number of events 1 • Up to 7 days post Ioforminol and Iopamidol administrations.	0.00% 0/141 • Up to 7 days post Ioforminol and Iopamidol administrations.
Cardiac disorders Congestive cardiac failure	0.73% 1/137 • Number of events 1 • Up to 7 days post Ioforminol and Iopamidol administrations.	0.71% 1/141 • Number of events 1 • Up to 7 days post Ioforminol and Iopamidol administrations.
Cardiac disorders Coronary artery disease	0.73% 1/137 • Number of events 1 • Up to 7 days post Ioforminol and Iopamidol administrations.	0.71% 1/141 • Number of events 2 • Up to 7 days post Ioforminol and Iopamidol administrations.
Cardiac disorders Coronary artery disease and hospitalization	0.73% 1/137 • Number of events 1 • Up to 7 days post Ioforminol and Iopamidol administrations.	0.00% 0/141 • Up to 7 days post Ioforminol and Iopamidol administrations.
Cardiac disorders Coronary artery stenosis	0.73% 1/137 • Number of events 1 • Up to 7 days post Ioforminol and Iopamidol administrations.	0.71% 1/141 • Number of events 1 • Up to 7 days post Ioforminol and Iopamidol administrations.
Cardiac disorders Tachycardia	0.00% 0/137 • Up to 7 days post Ioforminol and Iopamidol administrations.	0.71% 1/141 • Number of events 1 • Up to 7 days post Ioforminol and Iopamidol administrations.
Cardiac disorders Unstable angina	0.00% 0/137 • Up to 7 days post Ioforminol and Iopamidol administrations.	0.71% 1/141 • Number of events 1 • Up to 7 days post Ioforminol and Iopamidol administrations.
General disorders Chest discomfort	0.73% 1/137 • Number of events 1 • Up to 7 days post Ioforminol and Iopamidol administrations.	0.00% 0/141 • Up to 7 days post Ioforminol and Iopamidol administrations.
General disorders Chest pain	0.73% 1/137 • Number of events 1 • Up to 7 days post Ioforminol and Iopamidol administrations.	0.00% 0/141 • Up to 7 days post Ioforminol and Iopamidol administrations.
General disorders Vascular pseudoaneurysm to hospitalization	0.73% 1/137 • Number of events 1 • Up to 7 days post Ioforminol and Iopamidol administrations.	0.00% 0/141 • Up to 7 days post Ioforminol and Iopamidol administrations.
General disorders Dyspnea	0.00% 0/137 • Up to 7 days post Ioforminol and Iopamidol administrations.	0.71% 1/141 • Number of events 1 • Up to 7 days post Ioforminol and Iopamidol administrations.
General disorders Hematoma	0.00% 0/137 • Up to 7 days post Ioforminol and Iopamidol administrations.	0.71% 1/141 • Number of events 1 • Up to 7 days post Ioforminol and Iopamidol administrations.
General disorders Non-cardiac chest pain	0.00% 0/137 • Up to 7 days post Ioforminol and Iopamidol administrations.	0.71% 1/141 • Number of events 1 • Up to 7 days post Ioforminol and Iopamidol administrations.
Surgical and medical procedures Coronary artery bypass	0.73% 1/137 • Number of events 1 • Up to 7 days post Ioforminol and Iopamidol administrations.	0.00% 0/141 • Up to 7 days post Ioforminol and Iopamidol administrations.
Surgical and medical procedures Cardiac pacemaker insertion to hospitalization	0.73% 1/137 • Number of events 1 • Up to 7 days post Ioforminol and Iopamidol administrations.	0.00% 0/141 • Up to 7 days post Ioforminol and Iopamidol administrations.