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| Name | Class |
|---|---|
| i3 Statprobe | INDUSTRY |
| Medpace, Inc. | INDUSTRY |
| Biomedical Systems | INDUSTRY |
| Rules-Based Medicine, Inc. |
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To evaluate cardio-renal and overall safety profile of GE 145 320 mg I/ml Injection when compared to iopamidol 370 mg I/mL. The study will focus on elderly subjects with either chronic renal insufficiency, or diabetes mellitus (DM) requiring drug therapy, or congestive heart failure (CHF) NYHA Class III or greater, who are referred for a coronary catheterization procedure with or without PCI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GE 145 320mg I/ml injection | Experimental |
| |
| Iopamidol 370mg I/ml injection | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GE-145 | Drug | GE-145-320 mg I/mL as a single iv. administration. Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv. administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader. | Overall image quality (excellent, adequate or poor) and diagnostic usefulness (diagnostic or non-diagnostic) were assessed using qualitative scales. | After the imaging date for either Ioforminol or Iopamidol. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rubin Sheng, M.D. | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GE Healthcare | Princeton | New Jersey | 08540 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ioforminol 320mg I/ml Injection | Ioforminol 320 mg I/mL as a single iv. administration. |
| FG001 | Iopamidol 370mg I/ml Injection | Iopamidol 370 mg I/mL as a single iv. administration. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ioforminol 320mg I/ml Injection | Ioforminol 320 mg I/mL as a single iv. administration. |
| BG001 | Iopamidol 370mg I/ml Injection | Iopamidol 370 mg I/mL as a single iv. administration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader. | Overall image quality (excellent, adequate or poor) and diagnostic usefulness (diagnostic or non-diagnostic) were assessed using qualitative scales. | The measured values are looking at 1) Overall Image Quality and, 2) Diagnostic Usefulness. | Posted | Number | Number of subjects | After the imaging date for either Ioforminol or Iopamidol. |
|
Up to 7 days post Ioforminol and Iopamidol administrations.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ioforminol 320mg I/ml Injection | Ioforminol 320 mg I/mL as a single iv. administration. Up to 7 days post Iopamidol administration. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter-Site Hemotoma | General disorders | MedDRA 14.1 | Systematic Assessment | Site of Administration |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ruben Sheng, M.D. | GE Healthcare | 609-514-6899 | Rubin.Sheng@ge.com |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003920 | Diabetes Mellitus |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C553686 | 5-(formyl-(3-(formyl-(3,5-bis (2,3-dihydroxypropylcarbamoyl)-2,4,6-triiodophenyl) amino)-2-hydroxypropyl)amino)-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide |
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| INDUSTRY |
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|
| Time zero equals the date of contrast imaging and for up to 7 days for safety monitoring post contrast administration. |
| Assessing the Incidence of Renal Biomarker-based Contrast-induced Acute Kidney Injury (CI-AKI) in Subjects Post Administration of Ioforminol or Iopamidol Injections | Analyzing the number of subjects with renal biomarker-based contrast-induced acute kidney injury (CI-AKI). | 2, 6 and 24 hours post Ioforminol and Iopamidol adminstration |
| Physician Decision |
|
| Various reasons |
|
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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 | 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. | Summary of Treatment-Emergent Adverse Events (TEAE) in greater than of equal to 2% of Subjects. | Posted | Number | Number of events | Time zero equals the date of contrast imaging and for up to 7 days for safety monitoring post contrast administration. |
|
|
|
| Secondary | Assessing the Incidence of Renal Biomarker-based Contrast-induced Acute Kidney Injury (CI-AKI) in Subjects Post Administration of Ioforminol or Iopamidol Injections | Analyzing the number of subjects with renal biomarker-based contrast-induced acute kidney injury (CI-AKI). | Summary of subjects with renal biomarker-based CI-AKI by time point (Per Protocol Population). | Posted | Number | Subjects | 2, 6 and 24 hours post Ioforminol and Iopamidol adminstration |
|
|
|
| 13 |
| 137 |
| 20 |
| 137 |
| EG001 | Iopamidol 370mg I/ml Injection | Iopamidol 370 mg I/mL as a single iv. administration. Up to 7 days post Ioforminol administration. | 10 | 141 | 9 | 141 |
| Aortic stenosis | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Congestive cardiac failure | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Coronary artery disease and hospitalization | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Unstable angina | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Vascular pseudoaneurysm to hospitalization | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dyspnea | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hematoma | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Coronary artery bypass | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
|
| Cardiac pacemaker insertion to hospitalization | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
|
|
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| Diarrhea |
|
| Nausea |
|
| Catheter-Site Hematoma |
|
| Catheter-Site Hemorrhage |
|
| Catheter-Site Pain |
|
| Chest Pain |
|
| Urinary Tract Infection |
|
| Blood Creatinine Increased |
|
| Pain In Extremity |
|
| Dizziness |
|
| Headache |
|
| Time- Post Contrast, 24 hourss |
|