NCT01947335

Brief Summary

This study tests the hypothesis that ultrasound-guided PCI reduces contrast volume during the procedure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

June 15, 2016

Completed
Last Updated

June 15, 2016

Status Verified

May 1, 2016

Enrollment Period

10 months

First QC Date

January 1, 2013

Results QC Date

May 6, 2016

Last Update Submit

May 6, 2016

Conditions

Contrast Media ReactionAcute Renal Failure

Keywords

CoronaryAngioplastyPercutaneous coronary interventionStentContrastAcute Renal failureIntravascular ultrasoundPrevention

Outcome Measures

Primary Outcomes (1)

  • Total Volume of Iodine Contrast Used During Procedure

    Total volume of iodine contrast administered during the index procedure.

    Day 1

Secondary Outcomes (2)

  • Major Adverse Cardiac Events

    30 days and 6 months

  • Incidence of Contrast-induced Nephropathy

    7 days

Study Arms (2)

Angiography-guided PCI

NO INTERVENTION

Angiography-guided percutaneous coronary intervention

IVUS-guided PCI

ACTIVE COMPARATOR

Intravascular ultrasound guided percutaneous coronary intervention

Device: IVUS-guided PCI

Interventions

IVUS-guided PCIDEVICE

Intravascular ultrasound guided percutaneous coronary intervention

Also known as: Intravascular ultrasound
IVUS-guided PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute - InCor. University of Sao Paulo Medical School

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 25326742DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Ultrasonography, Interventional

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Limitations and Caveats

Patients were enrolled according to somewhat restricted criteria, which excluded patients with recent catheterization, using nephrotoxic agents, or with unstable or unknown renal function.

Results Point of Contact

Title
Dr. Pedro A. Lemos
Organization
Heart Institute (Incor)
pedro.lemos@incor.usp.br
+55 11 2661 5000

Study Officials

  • Pedro A Lemos, MD PhD

    Heart Institute - InCor. University of Sao Paulo Medical School

    STUDY CHAIR

  • Paulo R Soares, MD PhD

    Heart Institute - InCor. University of Sao Paulo Medical School

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 1, 2013

First Posted

September 20, 2013

Study Start

November 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

June 15, 2016

Results First Posted

June 15, 2016

Record last verified: 2016-05

Locations

BR(1)