Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Renal Insufficiency Congestive Heart Failure Diabete Mellitus

Keywords

CATH CatheterizationCI-AKI Contrast-induced acute kidney injuryDM Diabetes mellituseGFR Estimated glomerular filtration rateMDRD Modification of Diet in Renal DiseaseNYHA New York Heart AssociationPCI Percutaneous coronary interventionSCr Serum creatinine

Outcome Measures

Primary Outcomes (1)

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.

Secondary Outcomes (2)

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 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

Study Arms (2)

GE 145 320mg I/ml injection

EXPERIMENTAL

Drug: GE-145

Iopamidol 370mg I/ml injection

ACTIVE COMPARATOR

Drug: GE-145

Interventions

GE-145Drug

GE-145-320 mg I/mL as a single iv. administration. Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv. administration.

Also known as: Ioforminol

GE 145 320mg I/ml injectionIopamidol 370mg I/ml injection

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age65 Years+

Sexall

Healthy VolunteersNo

Age GroupsOlder Adult (65+)

You may qualify if:

Males and females 65 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:

Sponsors & Collaborators

Rules-Based Medicine, Inc.
Industrycollaborator
Biomedical Systems
Industrycollaborator
i3 Statprobe

Study Sites (1)

GE Healthcare

Princeton, New Jersey, 08540, United States

MeSH Terms

Conditions

Renal Insufficiency, ChronicDiabetes MellitusHeart Failure

Interventions

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

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease Attributes

Results Point of Contact

Title: Ruben Sheng, M.D.
Organization: GE Healthcare

Study Officials

Rubin Sheng, M.D.
GE Healthcare
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

284 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: DIAGNOSTIC
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 1, 2010

First Posted

December 3, 2010

Study Start

November 2010

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

GE 145 320mg I/ml injection

Iopamidol 370mg I/ml injection

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

GE 145 320mg I/ml injection

Iopamidol 370mg I/ml injection

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations