Contrast Media ReactionPhase 4MOZARTNCT01947335
IVUS Guidance to Reduce Contrast in Coronary Angioplasty
A Phase 4 study testing IVUS-guided PCI in people with Contrast Media Reaction and Acute Renal Failure, run by InCor Heart Institute at 1 site in Brazil.
Trial summary
This study tests the hypothesis that ultrasound-guided PCI reduces contrast volume during the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast Media Reaction, Acute Renal Failure
- What is being tested?
- IVUS-guided PCI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2012to Sep 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Written informed consent
- Age >=18 years
- Coronary artery disease scheduled for percutaneous intervention
- Technical feasibility for intravascular ultrasound to guide coronary angioplasty
- Increased risk for contrast-induced acute renal failure (e.g. age > 80 years, female gender, diabetes, urgent or emergent procedure priority, diabetes, congestive heart failure, increased baseline serum creatinine, decreased calculated or measured creatinine clearance, intra-aortic balloon pumping, previous renal transplantation or single kidney)
Who cannot join
- Anticipated technical impossibility for intravascular ultrasound
- Unknown baseline renal function
- Baseline end-stage renal failure needing dialysis
- Acute renal failure with dynamic change in renal function at the time of index procedure
- Iodine contrast administration <= 72 prior to index procedure
- Known allergy to iodine contrast
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute - InCor. University of Sao Paulo Medical School
São Paulo, São Paulo, 05403-000
About this study
Official title: Minimizing cOntrast utiliZAtion With IVUS Guidance in coRonary angioplasTy: The MOZART Study
This study tests the hypothesis that ultrasound-guided PCI reduces contrast volume during the procedure.
Read the detailed description
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 the PCI strategy. IVUS allows accurate vessel and lesion sizing, determination of plaque calcification (and the need for pre-stent plaque preparation), assessment of post-stent results (including edge dissections and residual lesion, as well as stent underexpansion or incomplete apposition). Therefore, IVUS has the potential to reduce the utilization of contrast media during PCI.
In the present study, we hypothesize that IVUS guidance is associated with a significant reduction in the volume of contrast media during PCI, in comparison to standard angiography-guided intervention.
- Conditions
- Contrast Media Reaction, Acute Renal Failure
- Being tested
- IVUS-guided PCI
- Keywords
- Coronary, Angioplasty, Percutaneous coronary intervention, Stent, Contrast, Acute Renal failure, Intravascular ultrasound, Prevention
- 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 PCIDevice
Also called Intravascular ultrasound
Intravascular ultrasound guided percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| Angiography-guided PCI | No intervention | Angiography-guided percutaneous coronary intervention |
| IVUS-guided PCI | Active comparator | Intravascular ultrasound guided percutaneous coronary intervention Receives: Device: IVUS-guided PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Volume of Iodine Contrast Used During Procedure
Total volume of iodine contrast administered during the index procedure.
Measured: Day 1
Secondary outcomes (2)
Major Adverse Cardiac Events
Composite of death, myocardial infarction or repeat revascularization
Measured: 30 days and 6 months
Incidence of Contrast-induced Nephropathy
Increase >= 0.5 mg/dl in basal serum creatinine
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startNov 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contrast Media ReactionStudies 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
- 83 participants (actual)
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, Study chair, Heart Institute - InCor. University of Sao Paulo Medical SchoolPaulo R Soares, MD PhD, Principal investigator, Heart Institute - InCor. University of Sao Paulo Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947335
- Sponsor's protocol ID
- 02358512.7.0000.0068
- Acronym
- MOZART
- Status last verified
- May 2016
- First submitted
- 1 Jan 2013
- Last updated
- 15 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mariani J Jr, Guedes C, Soares P, Zalc S, Campos CM, Lopes AC, Spadaro AG, Perin MA, Filho AE, Takimura CK, Ribeiro E, Kalil-Filho R, Edelman ER, Serruys PW, Lemos PA. Intravascular ultrasound guidance to minimize the use of iodine contrast in percutaneous coronary intervention: the MOZART (Minimizing cOntrast utiliZation With IVUS Guidance in coRonary angioplasTy) randomized controlled trial. JACC Cardiovasc Interv. 2014 Nov;7(11):1287-93. doi: 10.1016/j.jcin.2014.05.024. Epub 2014 Oct 15.
PubMed 25326742
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 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: The MOZART Study
- ClinicalTrials.gov ID
- NCT01947335
- Acronym / sponsor ID
- MOZART / 02358512.7.0000.0068
- Conditions
- Contrast Media Reaction, Acute Renal Failure
- Keywords
- Coronary, Angioplasty, Percutaneous coronary intervention, Stent, Contrast, Acute Renal failure, Intravascular ultrasound, Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- InCor Heart InstituteUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 Sep 2013 (estimated)
- Results
- Posted 15 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tests the hypothesis that ultrasound-guided PCI reduces contrast volume during the procedure.
Detailed description
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 the PCI strategy. IVUS allows accurate vessel and lesion sizing, determination of plaque calcification (and the need for pre-stent plaque preparation), assessment of post-stent results (including edge dissections and residual lesion, as well as stent underexpansion or incomplete apposition). Therefore, IVUS has the potential to reduce the utilization of contrast media during PCI.
In the present study, we hypothesize that IVUS guidance is associated with a significant reduction in the volume of contrast media during PCI, in comparison to standard angiography-guided intervention.
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 | No intervention | –Angiography-guided percutaneous coronary intervention |
| IVUS-guided PCI | Active comparator | Device: 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)
- Written informed consent
- Age >=18 years
- Coronary artery disease scheduled for percutaneous intervention
- Technical feasibility for intravascular ultrasound to guide coronary angioplasty
- Increased risk for contrast-induced acute renal failure (e.g. age > 80 years, female gender, diabetes, urgent or emergent procedure priority, diabetes, congestive heart failure, increased baseline serum creatinine, decreased calculated or measured creatinine clearance, intra-aortic balloon pumping, previous renal transplantation or single kidney)
Key exclusion criteria (6 listed)
- Anticipated technical impossibility for intravascular ultrasound
- Unknown baseline renal function
- Baseline end-stage renal failure needing dialysis
- Acute renal failure with dynamic change in renal function at the time of index procedure
- Iodine contrast administration <= 72 prior to index procedure
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 | Device | IVUS-guided PCI |
Primary outcome
Total Volume of Iodine Contrast Used During Procedure
Time frame: Day 1
Total volume of iodine contrast administered during the index procedure.
2 secondary outcomes
Major Adverse Cardiac Events
Time frame: 30 days and 6 months
Incidence of Contrast-induced Nephropathy
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25326742Mariani J Jr, Guedes C, Soares P, Zalc S, Campos CM, Lopes AC, Spadaro AG, Perin MA, Filho AE, Takimura CK, Ribeiro E, Kalil-Filho R, Edelman ER, Serruys PW, Lemos PA. Intravascular ultrasound guidance to minimize the use of iodine contrast in percutaneous coronary intervention: the MOZART (Minimizing cOntrast utiliZation With IVUS Guidance in coRonary angioplasTy) randomized controlled trial. JACC Cardiovasc Interv. 2014 Nov;7(11):1287-93. doi: 10.1016/j.jcin.2014.05.024. Epub 2014 Oct 15.
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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 study chair
Heart Institute - InCor. University of Sao Paulo Medical School
Paulo R Soares, MD PhD principal investigator
Heart Institute - InCor. University of Sao Paulo Medical School
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 IVUS-guided PCI in people with Contrast Media Reaction and Acute Renal Failure, run by InCor Heart Institute at 1 site in Brazil.
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 6 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 Jun 2016. 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 Brazil. 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?
Yes. Results are posted in the registry (first posted 15 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Volume of Iodine Contrast Used During Procedure (time frame: Day 1). 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 NCT01947335, 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 15 Jun 2016.