Contrast Induced NephropathyPhase 4CONTRAST-AMINCT00827788
Comparison Between Iso-Osmolar and Ipo-Osmolar Contrast Agents in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary Percutaneous Coronary Intervention (PCI)
A Phase 4 study testing Iodixanol and Iopromide in people with Contrast Induced Nephropathy and Acute Myocardial Infarction, run by Ospedale San Donato at 1 site in Italy.
Trial summary
The purpose of this study is to determine the incidence of contrast induced nephropathy and myocardial tissue reperfusion following iso-osmolar iodixanol or ipo-osmolar iopromide administration in patients with acute myocardial infarction undergoing primary PCI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast Induced Nephropathy, Acute Myocardial Infarction
- What is being tested?
- Iodixanol and Iopromide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2008to Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged ≥ 18
- Patients with ST-elevation Myocardial Infarction presenting within 12 hours after the onset of symptoms (18 hours in case of cardiogenic shock), who are scheduled to undergo primary PCI
- Patients who have signed and dated the written informed consent form
Who cannot join
- Patients in pregnancy or lactation
- Long-term dialysis
- Administration of any investigational drug within the previous 30 days
- Intra-arterial or intravenous administration of iodinated contrast medium from 7 days before to 72 hours after the administration of study drug
- Intake of any nephrotoxic medications 24 hours before or after the administration of study drug
- Contraindications to the study drug or the cardiac catheterization procedure
- Previous participation in this study
- As the discretion of the investigator, the patient has any conditions not appropriate to the usage of iodinated contrast agent or not appropriate to undergo cardiac catheterization procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Contrast Media and Nephrotoxicity Following Coronary Revascularization by Primary Angioplasty for Acute Myocardial Infarction. The CONTRAST-AMI Study.
The purpose of this study is to determine the incidence of contrast induced nephropathy and myocardial tissue reperfusion following iso-osmolar iodixanol or ipo-osmolar iopromide administration in patients with acute myocardial infarction undergoing primary PCI.
Read the detailed description
This is a multicentric randomized comparison between iso-osmolar and ipo-osmolar contrast agents in patients treated with primary PCI with the evaluation of contrast-induced nephropathy incidence and myocardial tissue reperfusion. The study was designed as a non-inferiority trial.
- Being tested
- Iodixanol, Iopromide
- Keywords
- contrast media, angiography, percutaneous coronary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IodixanolDrug
Also called Visipaque®
Iso-osmolar contrast medium (Iodixanol) will be administered during PCI
IopromideDrug
Also called Ultravist®
Low-osmolar contrast medium (Iopromide) will be administered during PCI
| Study group | Role | What they receive |
|---|---|---|
| iodixanol | Active comparator | Iso-osmolar contrast medium (Iodixanol) will be administered during PCI Receives: Drug: Iodixanol |
| iopromide | Active comparator | Low-osmolar contrast medium (Iopromide) will be administered during PCI Receives: Drug: Iopromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Contrast Induced Nephropathy (CIN) between the two study groups, defined as relative increase of serum Creatinine of 25% or more from basal values
Measured: days 1, 2, 3, and at discharge
Secondary outcomes (7)
TIMI grade flow
Measured: before and after primary PCI
Corrected TFC (TIMI frame count)
Measured: after primary PCI
TMPG (TIMI Myocardial Perfusion Grade)
Measured: after PCI
LFR slope (load to function slope)
Measured: after primary PCI
MACE
Measured: 1, 6, 12 months
absolute increase in serum Creatinine
Measured: days 1, 2, 3, and at discharge
relative increase in serum creatinine of 50% or more
Measured: days 1, 2, 3, and at discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contrast Induced NephropathyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale San Donato
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale Le Scotte, Ospedale della Misericordia - Grosseto
- Investigators
- Leonardo Bolognese, MD, FESC, Principal investigator, Ospedale SanDonato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827788
- Sponsor's protocol ID
- Arezzo001
- Other IDs
- EUDRACT 2008-008491-13
- Acronym
- CONTRAST-AMI
- Status last verified
- Sep 2009
- First submitted
- 22 Jan 2009
- Last updated
- 16 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Bolognese L, Falsini G, Grotti S, Limbruno U, Liistro F, Carrera A, Angioli P, Picchi A, Ducci K, Pierli C. The contrast media and nephrotoxicity following coronary revascularization by primary angioplasty for acute myocardial infarction study: design and rationale of the CONTRAST-AMI study. J Cardiovasc Med (Hagerstown). 2010 Mar;11(3):199-206. doi: 10.2459/JCM.0b013e32833186a4.
PubMed 19829124
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contrast Media and Nephrotoxicity Following Coronary Revascularization by Primary Angioplasty for Acute Myocardial Infarction. The CONTRAST-AMI Study.
- ClinicalTrials.gov ID
- NCT00827788
- Acronym / sponsor ID
- CONTRAST-AMI / Arezzo001
- Keywords
- contrast media, angiography, percutaneous coronary intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- Ospedale San DonatoUniversity, hospital or other
- Collaborators
- Ospedale Le Scotte, Ospedale della Misericordia - Grosseto
- Study start
- Dec 2008
- Primary completion
- Apr 2010 (actual)
- First posted
- 23 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.
The purpose of this study is to determine the incidence of contrast induced nephropathy and myocardial tissue reperfusion following iso-osmolar iodixanol or ipo-osmolar iopromide administration in patients with acute myocardial infarction undergoing primary PCI.
Detailed description
This is a multicentric randomized comparison between iso-osmolar and ipo-osmolar contrast agents in patients treated with primary PCI with the evaluation of contrast-induced nephropathy incidence and myocardial tissue reperfusion. The study was designed as a non-inferiority trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iodixanol | Active comparator | Drug: IodixanolIso-osmolar contrast medium (Iodixanol) will be administered during PCI |
| iopromide | Active comparator | Drug: IopromideLow-osmolar contrast medium (Iopromide) will be administered during PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women aged ≥ 18
- Patients with ST-elevation Myocardial Infarction presenting within 12 hours after the onset of symptoms (18 hours in case of cardiogenic shock), who are scheduled to undergo primary PCI
- Patients who have signed and dated the written informed consent form
Key exclusion criteria (8 listed)
- Patients in pregnancy or lactation
- Long-term dialysis
- Administration of any investigational drug within the previous 30 days
- Intra-arterial or intravenous administration of iodinated contrast medium from 7 days before to 72 hours after the administration of study drug
- Intake of any nephrotoxic medications 24 hours before or after the administration of study drug
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 |
|---|---|---|
| IodixanolAlso: Visipaque®Iso-osmolar contrast medium (Iodixanol) will be administered during PCI | Drug | iodixanol |
| IopromideAlso: Ultravist®Low-osmolar contrast medium (Iopromide) will be administered during PCI | Drug | iopromide |
Primary outcome
Incidence of Contrast Induced Nephropathy (CIN) between the two study groups, defined as relative increase of serum Creatinine of 25% or more from basal values
Time frame: days 1, 2, 3, and at discharge
7 secondary outcomes
TIMI grade flow
Time frame: before and after primary PCI
Corrected TFC (TIMI frame count)
Time frame: after primary PCI
TMPG (TIMI Myocardial Perfusion Grade)
Time frame: after PCI
LFR slope (load to function slope)
Time frame: after primary PCI
MACE
Time frame: 1, 6, 12 months
absolute increase in serum Creatinine
Time frame: days 1, 2, 3, and at discharge
relative increase in serum creatinine of 50% or more
Time frame: days 1, 2, 3, and at discharge
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 16 Nov 2010.
- Derived from this study: PubMed 19829124Bolognese L, Falsini G, Grotti S, Limbruno U, Liistro F, Carrera A, Angioli P, Picchi A, Ducci K, Pierli C. The contrast media and nephrotoxicity following coronary revascularization by primary angioplasty for acute myocardial infarction study: design and rationale of the CONTRAST-AMI study. J Cardiovasc Med (Hagerstown). 2010 Mar;11(3):199-206. doi: 10.2459/JCM.0b013e32833186a4.
Related trials for Contrast Induced Nephropathy
Recruiting
Effectiveness of Remote Ischemic Preconditioning for Prevention of Contrast Induced Acute Kidney Injury in Patients Undergoing Coronary Angiograms.
Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI), Contrast-induced Nephropathy Following Coronary Angiogram (CIN)
Not yet recruitingObservational study
Uric Acid to Albumin Ratio for Predicting Contrast Associated Acute Kidney Injury After Cardiac and Non Cardiac Procedures
Contrast-Induced Nephropathy, Acute Kidney Injury
Not yet recruitingObservational study
An Observational Study of Percutaneous Glomerular Filtration Rate (TGFR) in the Early Warning of Contrast-induced Acute Kidney Injury During the Peri-examination Period of Emergency Enhanced CT
Contrast-associated Acute Kidney Injury
Not yet recruitingObservational study
Beyond the Mehran Risk Score: Predictive Value of Total Ischemic Time for Contrast-Induced Nephropathy in ST Segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention.
ST Elevation (STEMI) Myocardial Infarction, Contrast Induced Nephropathy (CIN)
Not yet recruitingObservational study
Contrast Volume as a Predictor of Kidney Injury Following Contrast-Enhanced CT
Contrast-Associated Acute Kidney Injury, Acute Kidney Injury
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.
Leonardo Bolognese, MD, FESC principal investigator
Ospedale SanDonato
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 Iodixanol and Iopromide in people with Contrast Induced Nephropathy and Acute Myocardial Infarction, run by Ospedale San Donato at 1 site in Italy.
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 3 inclusion and 8 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 16 Nov 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 Italy. 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 (CIN) between the two study groups, defined as relative increase of serum Creatinine of 25% or more from basal values (time frame: days 1, 2, 3, and at discharge). 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 NCT00827788, which also lists 1 linked publication.
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 16 Nov 2010.