Renal Insufficiency, ChronicPhase 4NCT00390585
Iodixanol vs. Iomeprol to Prevent Contrast-Induced Nephropathy After Coronary Intervention (CONTRAST)
A Phase 4 study testing Iodixanol 320 and Iomeprol 350 in people with Renal Insufficiency, Chronic and Angioplasty, Transluminal, Percutaneous Coronary, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.
Trial summary
The purpose of this study is to demonstrate that Iodixanol 320 is associated with a lower incidence of contrast-induced nephropathy (CIN) when compared with hyperosmolar contrast medium Iomeprol 350 in patients with impaired renal function undergoing percutaneous coronary interventions (PCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Chronic, Angioplasty, Transluminal, Percutaneous Coronary, Coronary Arteriosclerosis
- What is being tested?
- Iodixanol 320 and Iomeprol 350
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 2 sitesGermany
- Study dates
- Jul 2006to Dec 2008
- 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
- chronic renal failure
- Informed, written consent
Who cannot join
- Cardiogenic shock
- Dialysis
- kidney transplantation
- Concurrent intake of nephrotoxic medication
- Planned or proceeded parenteral (i.v. or i.a.) administration of iodine-containing contrast medium at least 7 days before/after catheterization.
- Contra-indications for the use of Iodixanol (e.g. allergies)
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- Women who are known to be pregnant, who are of childbearing potential and test positive for pregnancy, who have given birth within the last 90 days, who are breastfeeding
- Patient's inability to fully cooperate with the study protocol.
- Previous enrollment in this trial
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
1. Medizinische Klinik, Klinikum rechts der Isar
München, 81675
Deutsches Herzzentrum Muenchen
Munich, 80636
About this study
Official title: Prospective, Randomized, Comparative Study to Evaluate the Effect of Iodixanol 320 Compared to Iomeprol 350 on Contrast Medium Induced Nephropathy in Patients With Impaired Renal Function Undergoing PCI
The purpose of this study is to demonstrate that Iodixanol 320 is associated with a lower incidence of contrast-induced nephropathy (CIN) when compared with hyperosmolar contrast medium Iomeprol 350 in patients with impaired renal function undergoing percutaneous coronary interventions (PCI).
Read the detailed description
Iodixanol, an iso-osmolar, dimeric, non-ionic contrast agent has been shown to reduce the risk of developing CIN in patients with elevated serum creatinine concentrations compared to low-osmolar contrast agents. However, no information is available about a potential protective effect of Iodixanol in patients with impaired renal function on CIN when used during PCI. Due to the high volume of contrast exposition, patients with impaired renal function are at increased risk for the development of CIN compared to patients with normal excretory renal function.
The purpose of the investigation is to determine the changes of renal function in patients with impaired renal function receiving Iodixanol 320 or Iomeprol 350 for percutaneous coronary intervention.
- Conditions
- Renal Insufficiency, Chronic, Angioplasty, Transluminal, Percutaneous Coronary, Coronary Arteriosclerosis
- Being tested
- Iodixanol 320, Iomeprol 350
- Keywords
- Renal Insufficiency, Angioplasty, Transluminal, Percutaneous Coronary, Contrast media
- Medical subject headings
- Renal Insufficiency, Chronic, Coronary Artery Disease, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodixanol 320Drug
Also called VISIPAQUE (TM)
Iodixanol 320 is used as contrast media while coronary intervention.
Iomeprol 350Drug
Also called Imeron
Iomeprol 350 is used as contrast media while coronary intervention.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Iodixanol 320 Receives: Drug: Iodixanol 320 |
| B | Active comparator | Iomeprol 350 Receives: Drug: Iomeprol 350 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast-induced nephropathy after percutaneous coronary intervention during primary hospitalization
Measured: primary hospitalization
Secondary outcomes (4)
Duration of primary hospitalization
Measured: Duration of primary hospitalization
Incidence of severe acute kidney failure
Measured: severe acute kidney failure
Contrast-induced nephropathy six months after PCI
Measured: 6 months
Mortality and myocardial infarction at 6 and 12 months
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2006 (estimated)
- Study startJul 2006
- Primary completionJan 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Investigators
- Albert Schoemig, MD, Study chair, Deutsches Herzzentrum MuenchenRainer Wessely, MD, Principal investigator, Deutsches Herzzentrum Muenchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390585
- Sponsor's protocol ID
- GE IDE No. E00605
- Status last verified
- Feb 2008
- First submitted
- 19 Oct 2006
- Last updated
- 15 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999 Mar 16;130(6):461-70. doi: 10.7326/0003-4819-130-6-199903160-00002.
PubMed 10075613Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998 Jul;15(7):539-53. doi: 10.1002/(SICI)1096-9136(199807)15:73.0.CO;2-S.
PubMed 9686693Wessely R, Koppara T, Bradaric C, Vorpahl M, Braun S, Schulz S, Mehilli J, Schomig A, Kastrati A; Contrast Media and Nephrotoxicity Following Coronary Revascularization by Angioplasty Trial Investigators. Choice of contrast medium in patients with impaired renal function undergoing percutaneous coronary intervention. Circ Cardiovasc Interv. 2009 Oct;2(5):430-7. doi: 10.1161/CIRCINTERVENTIONS.109.874933. Epub 2009 Sep 22.
PubMed 20031753
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Comparative Study to Evaluate the Effect of Iodixanol 320 Compared to Iomeprol 350 on Contrast Medium Induced Nephropathy in Patients With Impaired Renal Function Undergoing PCI
- ClinicalTrials.gov ID
- NCT00390585
- Acronym / sponsor ID
- GE IDE No. E00605
- Conditions
- Renal Insufficiency, Chronic, Angioplasty, Transluminal, Percutaneous Coronary, Coronary Arteriosclerosis
- Keywords
- Renal Insufficiency, Angioplasty, Transluminal, Percutaneous Coronary, Contrast media
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Oct 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 purpose of this study is to demonstrate that Iodixanol 320 is associated with a lower incidence of contrast-induced nephropathy (CIN) when compared with hyperosmolar contrast medium Iomeprol 350 in patients with impaired renal function undergoing percutaneous coronary interventions (PCI).
Detailed description
Iodixanol, an iso-osmolar, dimeric, non-ionic contrast agent has been shown to reduce the risk of developing CIN in patients with elevated serum creatinine concentrations compared to low-osmolar contrast agents. However, no information is available about a potential protective effect of Iodixanol in patients with impaired renal function on CIN when used during PCI. Due to the high volume of contrast exposition, patients with impaired renal function are at increased risk for the development of CIN compared to patients with normal excretory renal function.
The purpose of the investigation is to determine the changes of renal function in patients with impaired renal function receiving Iodixanol 320 or Iomeprol 350 for percutaneous coronary intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Iodixanol 320Iodixanol 320 |
| B | Active comparator | Drug: Iomeprol 350Iomeprol 350 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic renal failure
- Informed, written consent
Key exclusion criteria (9 listed)
- Cardiogenic shock
- Dialysis
- kidney transplantation
- Concurrent intake of nephrotoxic medication
- Planned or proceeded parenteral (i.v. or i.a.) administration of iodine-containing contrast medium at least 7 days before/after catheterization.
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 320Also: VISIPAQUE (TM)Iodixanol 320 is used as contrast media while coronary intervention. | Drug | A |
| Iomeprol 350Also: ImeronIomeprol 350 is used as contrast media while coronary intervention. | Drug | B |
Primary outcome
Contrast-induced nephropathy after percutaneous coronary intervention during primary hospitalization
Time frame: primary hospitalization
4 secondary outcomes
Duration of primary hospitalization
Time frame: Duration of primary hospitalization
Incidence of severe acute kidney failure
Time frame: severe acute kidney failure
Contrast-induced nephropathy six months after PCI
Time frame: 6 months
Mortality and myocardial infarction at 6 and 12 months
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2010.
- Background: PubMed 10075613Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999 Mar 16;130(6):461-70. doi: 10.7326/0003-4819-130-6-199903160-00002.
- Background: PubMed 9686693Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998 Jul;15(7):539-53. doi: 10.1002/(SICI)1096-9136(199807)15:73.0.CO;2-S.
- Results publication: PubMed 20031753Wessely R, Koppara T, Bradaric C, Vorpahl M, Braun S, Schulz S, Mehilli J, Schomig A, Kastrati A; Contrast Media and Nephrotoxicity Following Coronary Revascularization by Angioplasty Trial Investigators. Choice of contrast medium in patients with impaired renal function undergoing percutaneous coronary intervention. Circ Cardiovasc Interv. 2009 Oct;2(5):430-7. doi: 10.1161/CIRCINTERVENTIONS.109.874933. Epub 2009 Sep 22.
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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.
Albert Schoemig, MD study chair
Deutsches Herzzentrum Muenchen
Rainer Wessely, MD principal investigator
Deutsches Herzzentrum Muenchen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iodixanol 320 and Iomeprol 350 in people with Renal Insufficiency, Chronic and Angioplasty, Transluminal, Percutaneous Coronary, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 15 Mar 2010. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Contrast-induced nephropathy after percutaneous coronary intervention during primary hospitalization (time frame: primary hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00390585, which also lists 3 linked publications.
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 15 Mar 2010.