Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure
This study is ongoing, but not recruiting participants.
Sponsor:
GE Healthcare
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: March 9, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardio Renal Safety in High-risk Elderly Subjects Undergoing a Coronary CATH With or Without PCI. |
Drug: GE-145 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Diagnostic |
| Official Title: | A Phase 2, Double-Blind, Randomized, Safety Study of GE-145 320 mg I/mL Injection Versus Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Artery Catheterization Procedure |
Resource links provided by NLM:
Further study details as provided by GE Healthcare:
Primary Outcome Measures:
- Comparison of the incidence rates of cardio-renal adverse reactions in elderly subjects with at least one additional co-morbidities undergoing coronary catheterization [ Time Frame: Time zero equals the date of contrast imaging and for up to 7 days for safety monitoring post contrast administration. ] [ Designated as safety issue: Yes ]Comparison of the incidence rates of cardio-renal adverse reactions in elderly subjects with at least one additional co-morbidities undergoing coronary catheterization with or without PCI involving intra-arterial administration of either GE-145 320 mg I/mL Injection or iopamidol 370 mg I/mL.
Secondary Outcome Measures:
- 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. ] [ Designated as safety issue: Yes ]
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.
| Estimated Enrollment: | 250 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: GE 145 320mg I/ml injection |
Drug: GE-145
GE-145-320 mg I/mL as a single iv. administration. Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv. administration.
Other Name: Ioforminol
|
| Active Comparator: Iopamidol 370mg I/ml injection |
Drug: GE-145
GE-145-320 mg I/mL as a single iv. administration. Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv. administration.
Other Name: Ioforminol
|
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males and females 70 years of age with cardiovascular disease who are referred for a coronary catheterization procedure with or without PCI.
- The subject has at least one of the following comorbidities:
- 1) Chronic renal insufficiency, (eGFR <60 but 15 mL/min/1.73 m2 according to the MDRD equation) as measured within 2 weeks or at the screening visit;
- 2) DM diagnosed greater than 6 months prior to study entry and which requires either insulin or anti-hyperglycemic drug therapy;
- 3) CHF (NYHA) class III or greater measured within 2 weeks of enrollment or at the screening visit.
Exclusion Criteria:
- The subject has known allergies to either iodine or any ICM.
- The subject has severe renal insufficiency (eGFR <15 mL/min/1.73 m2 according to the MDRD equation) or is on dialysis.
- The subject has acute coronary syndrome requiring emergency coronary angiography and/or intervention.
- The subject is not willing or unable to discontinue metformin (e.g., Glucophage) at the time of the study procedure.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252810
Locations
| United States, New Jersey | |
| GE Healthcare | |
| Princeton, New Jersey, United States, 08540 | |
Sponsors and Collaborators
GE Healthcare
i3 Statprobe
Medpace, Inc.
Biomedical Systems
Rules-Based Medicine (RBM)
Investigators
| Study Director: | Rubin Sheng, M.D. | GE Healthcare |
More Information
No publications provided
| Responsible Party: | GE Healthcare |
| ClinicalTrials.gov Identifier: | NCT01252810 History of Changes |
| Other Study ID Numbers: | GE 045-002 |
| Study First Received: | December 1, 2010 |
| Last Updated: | March 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GE Healthcare:
|
CATH Catheterization CI-AKI Contrast-induced acute kidney injury DM Diabetes mellitus eGFR Estimated glomerular filtration rate |
MDRD Modification of Diet in Renal Disease NYHA New York Heart Association PCI Percutaneous coronary intervention SCr Serum creatinine |
ClinicalTrials.gov processed this record on May 19, 2013