Coronary Artery Disease (CAD)Phase 4NCT00335101
Renal Effects of Three Iodinated Contrast Media (CM) in Patients at Risk Undergoing Coronary Angiography
A Phase 4 study testing Iodixanol, Ioversol, Iopromide in people with Coronary Artery Disease (CAD) and Renal Impairment, run by GE Healthcare at 2 sites in 2 countries.
Trial summary
The study is to evaluate and compare the effects on kidney function of three iodinated contrast media (CM) in patients at risk of kidney damage evaluating serum creatinine (Scr) concentrations up to three days after CM administration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD), Renal Impairment, Diabetes Mellitus
- What is being tested?
- Iodixanol, Ioversol, Iopromide
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2006to not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a combination of DM (type I or II) and renal impairment (RI), defined as 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.
Who cannot join
- Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not allowed. Subjects undergoing dialysis or kidney transplantation or with CrCl < 20 mL/min will not be included.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The study is to evaluate and compare the effects on kidney function of three iodinated contrast media (CM) in patients at risk of kidney damage evaluating serum creatinine (Scr) concentrations up to three days after CM administration.
- Being tested
- Iodixanol, Ioversol, Iopromide
- Keywords
- Coronary Artery Disease (CAD), Renal Impairment, Serum creatinine (SCr), Iodixanol, Ioversol, Iopromide, Contrast Induced Nephropathy (CIN)
- Medical subject headings
- Coronary Artery Disease, Renal Insufficiency, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodixanol, Ioversol, IopromideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint:
Maximum peak increase in SCr from baseline up to day 3.
Secondary endpoints:
Change in SCr from baseline to day 2 and to day 3
Number of subjects with contrast-induced nephropathy (CIN)
Quality of diagnostic information
Secondary outcomes (3)
Coronary Artery Disease (CAD)
Renal Impairment
Diabetes mellitus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2006 (estimated)
- Study startJun 2006
Why it stopped: Sponsor Decision to withdraw study (comparative product withdrawn from the market)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Pignot, PhD, Study director, GE HealthcareJohnny Gibbs, Jr., CCRA, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335101
- Sponsor's protocol ID
- GE-012-091
- Status last verified
- Apr 2019
- First submitted
- 6 Jun 2006
- Last updated
- 29 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Effects of Three Iodinated Contrast Media (CM) in Patients at Risk Undergoing Coronary Angiography
- ClinicalTrials.gov ID
- NCT00335101
- Acronym / sponsor ID
- GE-012-091
- Keywords
- Coronary Artery Disease (CAD), Renal Impairment, Serum creatinine (SCr), Iodixanol, Ioversol, Iopromide, Contrast Induced Nephropathy (CIN)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor Decision to withdraw study (comparative product withdrawn from the market)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- First posted
- 8 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is to evaluate and compare the effects on kidney function of three iodinated contrast media (CM) in patients at risk of kidney damage evaluating serum creatinine (Scr) concentrations up to three days after CM administration.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with a combination of DM (type I or II) and renal impairment (RI), defined as 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.
Key exclusion criteria (1 listed)
- Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not allowed. Subjects undergoing dialysis or kidney transplantation or with CrCl < 20 mL/min will not be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iodixanol, Ioversol, Iopromide | Drug | – |
Primary outcome
Primary endpoint:
Maximum peak increase in SCr from baseline up to day 3.
Secondary endpoints:
Change in SCr from baseline to day 2 and to day 3
Number of subjects with contrast-induced nephropathy (CIN)
Quality of diagnostic information
3 secondary outcomes
Coronary Artery Disease (CAD)
Renal Impairment
Diabetes mellitus
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Pignot, PhD study director
GE Healthcare
Johnny Gibbs, Jr., CCRA study director
GE Healthcare
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iodixanol, Ioversol, Iopromide in people with Coronary Artery Disease (CAD) and Renal Impairment, run by GE Healthcare at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint:. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2019.