Chronic Renal InsufficiencyPhase 4NCT00823628
Contrast-medium Induced Nephrotoxicity in Patients Undergoing Coronary Angiography - Iodixanol Versus Iopromide
A Phase 4 study testing contrast agent (iopromide) and contrast agent (iodixanol) in people with Chronic Renal Insufficiency and Coronary Angiography, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
In the treatment of coronary heart disease which is the major cause of heart attack, direct mechanical treatment with catheters such as the coronary angiography, coronary balloon intervention and stenting intervention are the mainstay of therapy in recent years. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Renal Insufficiency, Coronary Angiography
- What is being tested?
- contrast agent (iopromide) and contrast agent (iodixanol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2009to Jun 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients who undergo coronary catheterization
- creatinine clearance rates ≤ 60 mL/min using the Cockcroft-Gault formula
Who cannot join
- pregnancy or lactation
- having received contrast media within 7 days of study entry
- emergent coronary angiography
- acute renal failure or end-stage renal disease requiring dialysis
- history of hypersensitivity reaction to contrast media
- unstable hemodynamic states such as cardiogenic shock, pulmonary edema or needing mechanical ventilation
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- multiple myeloma
- parenteral use of diuretics
- use of N-acetylcysteine
- use of metformin or nonsteroidal anti-inflammatory drugs within 48 hours of the procedure
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Cardiovascular Center, Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Comparison of Contrast-medium Induced Nephrotoxicity Between Iodixanol and Iopromide in Patients With Renal Insufficiency Undergoing Coronary Angiography
In the treatment of coronary heart disease which is the major cause of heart attack, direct mechanical treatment with catheters such as the coronary angiography, coronary balloon intervention and stenting intervention are the mainstay of therapy in recent years. In that procedures, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with underlying kidney disease and decreased kidney function. The investigators intended to find out which contrast agent has less kidney toxicity in the catheter based treatment of coronary arterial diseases in patients with underlying decreased kidney function
Read the detailed description
Iodixanol, a nonionic, dimeric, iso-osmolar contrast medium (IOCM), may be less nephrotoxic than nonionic, monomeric, low-osmolar contrast media (LOCMs) in high-risk patients. We compared the nephrotoxicity of iodixanol with that of iopromide, an nonionic, monomeric LOCM, in patients with renal impairment.
- Conditions
- Chronic Renal Insufficiency, Coronary Angiography
- Being tested
- contrast agent (iopromide), contrast agent (iodixanol)
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast agent (iopromide)Drug
coronary angiography using the allocated contrast agent
contrast agent (iodixanol)Drug
coronary angiography using the allocated contrast agent
| Study group | Role | What they receive |
|---|---|---|
| iopromide | Active comparator | Not described Receives: Drug: contrast agent (iopromide) |
| iodixanol | Experimental | Not described Receives: Drug: contrast agent (iodixanol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of contrast induced nephropathy, defined as either a relative increase in serum creatinine from baseline of >=25% or an absolute increase of >=0.5mg/dL(44.2µmol/L)
Measured: days 1 and 2
Secondary outcomes (1)
proportion of patients exhibiting an increase in serum creatinine of >=0.5mg/dL(44.2µmol/L), the proportion with a >=1.0 mg/dL(88.4µmol/L) increase in serum creatinine, and the mean peak increase in serum creatinine
Measured: days 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Tae-Jin Youn, MD, PhD, Study director, Facility: Cardiovascular Center, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823628
- Sponsor's protocol ID
- B-0902/069-003
- Status last verified
- Apr 2009
- First submitted
- 14 Jan 2009
- Last updated
- 7 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Contrast-medium Induced Nephrotoxicity Between Iodixanol and Iopromide in Patients With Renal Insufficiency Undergoing Coronary Angiography
- ClinicalTrials.gov ID
- NCT00823628
- Acronym / sponsor ID
- B-0902/069-003
- Conditions
- Chronic Renal Insufficiency, Coronary Angiography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 15 Jan 2009 (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.
In the treatment of coronary heart disease which is the major cause of heart attack, direct mechanical treatment with catheters such as the coronary angiography, coronary balloon intervention and stenting intervention are the mainstay of therapy in recent years. In that procedures, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with underlying kidney disease and decreased kidney function. The investigators intended to find out which contrast agent has less kidney toxicity in the catheter based treatment of coronary arterial diseases in patients with underlying decreased kidney function
Detailed description
Iodixanol, a nonionic, dimeric, iso-osmolar contrast medium (IOCM), may be less nephrotoxic than nonionic, monomeric, low-osmolar contrast media (LOCMs) in high-risk patients. We compared the nephrotoxicity of iodixanol with that of iopromide, an nonionic, monomeric LOCM, in patients with renal impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iopromide | Active comparator | Drug: contrast agent (iopromide) |
| iodixanol | Experimental | Drug: contrast agent (iodixanol) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients who undergo coronary catheterization
- creatinine clearance rates ≤ 60 mL/min using the Cockcroft-Gault formula
Key exclusion criteria (10 listed)
- pregnancy or lactation
- having received contrast media within 7 days of study entry
- emergent coronary angiography
- acute renal failure or end-stage renal disease requiring dialysis
- history of hypersensitivity reaction to contrast media
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 |
|---|---|---|
| contrast agent (iopromide)coronary angiography using the allocated contrast agent | Drug | iopromide |
| contrast agent (iodixanol)coronary angiography using the allocated contrast agent | Drug | iodixanol |
Primary outcome
Incidence of contrast induced nephropathy, defined as either a relative increase in serum creatinine from baseline of >=25% or an absolute increase of >=0.5mg/dL(44.2µmol/L)
Time frame: days 1 and 2
1 secondary outcome
proportion of patients exhibiting an increase in serum creatinine of >=0.5mg/dL(44.2µmol/L), the proportion with a >=1.0 mg/dL(88.4µmol/L) increase in serum creatinine, and the mean peak increase in serum creatinine
Time frame: days 1 and 2
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 7 Jul 2010.
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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.
Tae-Jin Youn, MD, PhD study director
Facility: Cardiovascular Center, Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing contrast agent (iopromide) and contrast agent (iodixanol) in people with Chronic Renal Insufficiency and Coronary Angiography, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 10 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 7 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
Incidence of contrast induced nephropathy, defined as either a relative increase in serum creatinine from baseline of >=25% or an absolute increase of >=0.5mg/dL(44.2µmol/L) (time frame: days 1 and 2). 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 7 Jul 2010.