Acute Kidney InjuryPhase 4Mozart-IINCT02743156
Minimizing Contrast Utilization With IVUS Guidance in Coronary Angioplasty to Avoid Acute Nephropathy
A Phase 4 study testing IVUS-guided PCI and Angiography-guided PCI in people with Acute Kidney Injury and Acute Renal Failure, run by InCor Heart Institute at 2 sites in 2 countries.
Trial summary
Contrast-induced acute kidney injury (CI-AKI) is an important adverse effect of percutaneous coronary interventions. Despite various efforts, very few preventive measures have been shown effective in reducing its incidence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Acute Renal Failure, Acute Renal Injury
- What is being tested?
- IVUS-guided PCI and Angiography-guided PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2016to May 2017
- 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
- Age over 18 years
- Coronary artery disease referred for percutaneous intervention, with stent implantation, of one or more epicardial vessel.
- ---->All target lesions must be amenable to IVUS imaging, as judged by an experienced interventionalist (lesions not assessable by IVUS at baseline but which are judged to the assessable at any time during the procedure are eligible).
- Baseline calculated creatinine clearance < 60 ml/min/1.73 m2 or baseline creatinine > 1.5 mg/dl
- Ability to sign informed consent and comply with all study procedures
Who cannot join
- Use of > 50 ml (single-lesion PCI) or > 70 ml (multi-lesion PCI) of iodinated agents < 72 hours (this restriction includes the contrast used during the diagnostic phase of ad hoc PCI).
- Planned use of iodinated contrast within the next 72 hours after the index procedure
- Use of other nephrotoxic agents < 7 days
- Known allergy to contrast agents
- Unstable or unknown renal function prior to PCI.
- Prior PCI of the target lesions
Show all 9Show fewer
- Patients requiring additional surgery (cardiac or non cardiac) within 72 hours after the index procedure
- Non cardiac co-morbidities with life expectancy less than 1 year
- Other investigational drug or device studies that have not reached their primary endpoint
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Brazil1 site, 1 recruiting
- Recruiting
Heart Institute - InCor. University of Sao Paulo Medical School
São Paulo, São Paulo, 05403-000
Pedro A Lemos, MD PhD
José Mariani Jr, MD
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic
Barcelona, Catalonia, 08036
Salvatore Brugaletta
About this study
Official title: Minimizing Contrast Utilization With IVUS Guidance in Coronary Angioplasty to Avoid Acute Nephropathy: The MOZART-II Study
Contrast-induced acute kidney injury (CI-AKI) is an important adverse effect of percutaneous coronary interventions. Despite various efforts, very few preventive measures have been shown effective in reducing its incidence.
The final volume of contrast media utilized during the procedure is a well- known independent factor affecting the occurrence of CI-AKI.
Read more
Intravascular ultrasound (IVUS) has been largely used as an adjunctive diagnostic tool during percutaneous coronary intervention (PCI). When fully explored, IVUS provides precise information for guiding PCI, thereby reducing the usage of contrast media. Accordingly, the recent MOZART study demonstrated that IVUS may lead to a 2-3-fold decrease in the volume of contrast media during PCI.
In the present study, the hypothesize that IVUS guidance, and its consequent reduction in the volume of contrast media, will in decrease the risk of CI-AKI after PCI, in comparison to standard angiography-guided intervention.
Read the detailed description
- Prospective, unblinded, randomized (1:1), multi-center trial of 300 patients allocated to one of the treatment arms (IVUS-guided PCI or angiography-guided PCI). Aggressive (non-IVUS) strategies to reduce contrast will be used in both study arms
- The study population will be composed of patients with renal dysfunction referred for PCI of one or more coronary vessels, all of them amenable to IVUS imaging
- After discharge, all subjects will be clinically followed-up for 1 year after the index procedure, at the following time-points: 30 and 180 days and 1 year.
- Unless contra-indicated, all patients elective will receive intravenous hydration during 12 hours pre- and 12 hours post-PCI. For patients with acute coronary syndrome, intensive intravenous hydration should be initiated as early as possible. Saline (NaCl 0.9%) infusion is recommended at a dose of 1 ml / kg body weight per hour, 25 and reduced to 0.5 ml/kg/h for those at high risk of volume overload (e.g. reduced left ventricular function or overt heart failure).The use of N-acetylcysteine or sodium bicarbonate will be left to operator discretion.
- Operators will be strongly recommended to follow strict strategies to reduce the total volume of contrast for all patients
- All percutaneous procedures will be performed using non-ionic, low-osmolar or iso-osmolar, iodine-based contrast media
- The study groups will be compared according to the intention-to-treat principle. Categorical variables will be compared by Fisher's exact testing and continuous variables by Student's T testing. Time-dependent events will be estimated by the Kaplan-Meier method and compared by Hazards Cox modeling or log-rank test
- Conditions
- Acute Kidney Injury, Acute Renal Failure, Acute Renal Injury
- Being tested
- IVUS-guided PCI, Angiography-guided PCI
- Keywords
- IVUS, Acute Renal Failure, Angioplasty, stent, contrast, percutaneous coronary intervention, intravascular ultrasound
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVUS-guided PCIProcedure or surgery
Also called intravascular ultrasound
intravascular ultrasound-guided percutaneous coronary intervention
Angiography-guided PCIProcedure or surgery
Angiography-guided percutaneous coronary intervention. This is the conventional treatment.
| Study group | Role | What they receive |
|---|---|---|
| angiography-guided PCI | Active comparator | angiography-guided percutaneous coronary intervention Receives: Procedure: Angiography-guided PCI |
| IVUS-guided PCI | Experimental | intravascular ultrasound guided percutaneous coronary intervention Receives: Procedure: IVUS-guided PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast-induced acute kidney injury
Evaluate whether IVUS-guided PCI reduces CI-AKI in
comparison to stand-alone angiography-guided PCI. CI-AKI will be defined as
an increase in serum creatinine ≥ 0.5 mg/dl from the baseline value, within
72 hours after the index procedure (or at discharge).
Measured: 72 hours
Secondary outcomes (5)
Major adverse cardiac events and components
cardiovascular death, myocardial infarction and target vessel revascularization
Measured: one year
Stent thrombosis
stent thrombosis will be defined as the occurrence of definite or probable stent thrombosis according to the Academic Research Consortium (ARC) criteria
Measured: one year
Serious acute kidney dysfunction
increase in serum creatinine ≥ 2 mg/dl or need for dialysis
Measured: one year
Procedure Time
Measured: procedure time
Radiation exposure
Measured: procedure time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InCor Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro A. Lemos, InCor Heart Institute
- Investigators
- Pedro A. Lemos, MD PhD, Principal investigator, Heart Institute - InCor. University of Sao Paulo Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743156
- Sponsor's protocol ID
- Mozart II
- Acronym
- Mozart-II
- Status last verified
- Apr 2016
- First submitted
- 10 Apr 2016
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimizing Contrast Utilization With IVUS Guidance in Coronary Angioplasty to Avoid Acute Nephropathy: The MOZART-II Study
- ClinicalTrials.gov ID
- NCT02743156
- Acronym / sponsor ID
- Mozart-II / Mozart II
- Conditions
- Acute Kidney Injury, Acute Renal Failure, Acute Renal Injury
- Keywords
- IVUS, Acute Renal Failure, Angioplasty, stent, contrast, percutaneous coronary intervention, intravascular ultrasound
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- InCor Heart InstituteUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 19 Apr 2016 (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.
Contrast-induced acute kidney injury (CI-AKI) is an important adverse effect of percutaneous coronary interventions. Despite various efforts, very few preventive measures have been shown effective in reducing its incidence.
The final volume of contrast media utilized during the procedure is a well- known independent factor affecting the occurrence of CI-AKI.
Intravascular ultrasound (IVUS) has been largely used as an adjunctive diagnostic tool during percutaneous coronary intervention (PCI). When fully explored, IVUS provides precise information for guiding PCI, thereby reducing the usage of contrast media. Accordingly, the recent MOZART study demonstrated that IVUS may lead to a 2-3-fold decrease in the volume of contrast media during PCI.
In the present study, the hypothesize that IVUS guidance, and its consequent reduction in the volume of contrast media, will in decrease the risk of CI-AKI after PCI, in comparison to standard angiography-guided intervention.
Detailed description
- Prospective, unblinded, randomized (1:1), multi-center trial of 300 patients allocated to one of the treatment arms (IVUS-guided PCI or angiography-guided PCI). Aggressive (non-IVUS) strategies to reduce contrast will be used in both study arms
- The study population will be composed of patients with renal dysfunction referred for PCI of one or more coronary vessels, all of them amenable to IVUS imaging
- After discharge, all subjects will be clinically followed-up for 1 year after the index procedure, at the following time-points: 30 and 180 days and 1 year.
- Unless contra-indicated, all patients elective will receive intravenous hydration during 12 hours pre- and 12 hours post-PCI. For patients with acute coronary syndrome, intensive intravenous hydration should be initiated as early as possible. Saline (NaCl 0.9%) infusion is recommended at a dose of 1 ml / kg body weight per hour, 25 and reduced to 0.5 ml/kg/h for those at high risk of volume overload (e.g. reduced left ventricular function or overt heart failure).The use of N-acetylcysteine or sodium bicarbonate will be left to operator discretion.
- Operators will be strongly recommended to follow strict strategies to reduce the total volume of contrast for all patients
- All percutaneous procedures will be performed using non-ionic, low-osmolar or iso-osmolar, iodine-based contrast media
- The study groups will be compared according to the intention-to-treat principle. Categorical variables will be compared by Fisher's exact testing and continuous variables by Student's T testing. Time-dependent events will be estimated by the Kaplan-Meier method and compared by Hazards Cox modeling or log-rank test
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| angiography-guided PCI | Active comparator | Procedure: Angiography-guided PCIangiography-guided percutaneous coronary intervention |
| IVUS-guided PCI | Experimental | Procedure: IVUS-guided PCIintravascular ultrasound guided percutaneous coronary intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age over 18 years
- Coronary artery disease referred for percutaneous intervention, with stent implantation, of one or more epicardial vessel.
- ---->All target lesions must be amenable to IVUS imaging, as judged by an experienced interventionalist (lesions not assessable by IVUS at baseline but which are judged to the assessable at any time during the procedure are eligible).
- Baseline calculated creatinine clearance < 60 ml/min/1.73 m2 or baseline creatinine > 1.5 mg/dl
- Ability to sign informed consent and comply with all study procedures
Key exclusion criteria (9 listed)
- Use of > 50 ml (single-lesion PCI) or > 70 ml (multi-lesion PCI) of iodinated agents < 72 hours (this restriction includes the contrast used during the diagnostic phase of ad hoc PCI).
- Planned use of iodinated contrast within the next 72 hours after the index procedure
- Use of other nephrotoxic agents < 7 days
- Known allergy to contrast agents
- Unstable or unknown renal function prior to PCI.
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 |
|---|---|---|
| IVUS-guided PCIAlso: intravascular ultrasoundintravascular ultrasound-guided percutaneous coronary intervention | Procedure or surgery | IVUS-guided PCI |
| Angiography-guided PCIAngiography-guided percutaneous coronary intervention. This is the conventional treatment. | Procedure or surgery | angiography-guided PCI |
Primary outcome
Contrast-induced acute kidney injury
Time frame: 72 hours
Evaluate whether IVUS-guided PCI reduces CI-AKI in comparison to stand-alone angiography-guided PCI. CI-AKI will be defined as an increase in serum creatinine ≥ 0.5 mg/dl from the baseline value, within 72 hours after the index procedure (or at discharge).
5 secondary outcomes
Major adverse cardiac events and components
Time frame: one year
Stent thrombosis
Time frame: one year
Serious acute kidney dysfunction
Time frame: one year
Procedure Time
Time frame: procedure time
Radiation exposure
Time frame: procedure time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
- Individual participant dataSharing planned: Undecided
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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.
Pedro A. Lemos, MD PhD principal investigator
Heart Institute - InCor. University of Sao Paulo Medical School
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 IVUS-guided PCI and Angiography-guided PCI in people with Acute Kidney Injury and Acute Renal Failure, run by InCor Heart Institute 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 5 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: status not confirmed, as of the sponsor's last update on 26 Apr 2016. 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 Brazil, Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Pereira (+551126615368, patricia@incor.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast-induced acute kidney injury (time frame: 72 hours). 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 26 Apr 2016.