Renal Effects of Two Iodinated Contrast Media in Patients... | NCT00209430

Studies
Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Coronary Angiography

NCT00209430

Sponsor

GE Healthcare

Status

Completed

Last Update Posted

Oct 31, 2007Estimated

Enrollment

408

Phase

Phase 4

Conditions

Coronary Artery Disease
Renal Impairment

Interventions

Iodixanol 320 mgI/mL

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2007

Last Update Posted Date

Oct 31, 2007Estimated

Description Module

Brief Summary

The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.

Detailed Description

GEHC has decided not to provide this detail

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

408

Name	Type	Description	Arm Group Labels	Other Names
Iodixanol 320 mgI/mL	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peak increase in SCr
Incidence of contrast media-induced nephropathy from baseline up to day 3.

Secondary Outcomes

Measure	Description	Time Frame
SCr concentrations up to days 3 and 7
image quality
occurrence of adverse events and their severity and relationship with the contrast media.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with a combination of diabetes mellitus (type I or II) and renal impairment, defined as serum creatinine (SCr ) ≥150 µmol/L (1.7 mg/dL) for men and ≥133 µmol/L (1.5 mg/dL) for women or creatinine clearance (CrCl) ≤ 50 mL/min calculated according to Cockroft-Gault formula, referred for coronary angiography with or without PCI.

Exclusion Criteria:

Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not allowed. Subjects undergoing dialysis or kidney transplant will not be included.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Caroline Widlund, BSc RN	GE Healthcare	Study Director
Johnny Gibbs, Jr., B.S., CCRA	609-514-6809	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Amersham Health S.A		Solna			Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19853704	Derived	Laskey W, Aspelin P, Davidson C, Rudnick M, Aubry P, Kumar S, Gietzen F, Wiemer M; DXV405 Study Group. Nephrotoxicity of iodixanol versus iopamidol in patients with chronic kidney disease and diabetes mellitus undergoing coronary angiographic procedures. Am Heart J. 2009 Nov;158(5):822-828.e3. doi: 10.1016/j.ahj.2009.08.016.

ID	Term
D003324	Coronary Artery Disease
D051437	Renal Insufficiency

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases