CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 445 enrolled
Drug / intervention
Sestamibidrug
Likely dose
Sestamibi administered for myocardial perfusion imaging (specific dose not stated)AI-extracted
Key inclusion· 3
  • ✓Age 4–16 years
  • ✓Confirmed Kawasaki disease or incomplete KD with evidence of coronary artery disease
  • ✓Able to exercise adequately to achieve 85% age-predicted maximum heart rate
Key exclusion· 1
  • ✕Terminal illness with expected survival <6 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00162032
NCT00162032Phase 3Completed
CompareCT.gov

A Phase III, Open-Label, Non-Randomized, International, Multicenter Trial to Evaluate the Efficacy and Safety of CARDIOLITE® Myocardial Perfusion Imaging in Pediatric Subjects With Kawasaki Disease

Lantheus Medical Imaging·interventional·Posted Sep 13, 2005·Updated Jul 23, 2019

In Brief

A Phase 3 clinical trial evaluating Sestamibi for Kawasaki Disease. Completed, enrolled 445 participants across 50 sites in 7 countries.

Detailed Summary

Determine the predictive value of CARDIOLITE® rest and stress myocardial perfusion imaging (MPI) to define a pediatric population with Kawasaki Disease (KD) at high and low risk of developing cardiac events.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKawasaki Disease
CountriesBrazil, Canada, Philippines, South Korea, Taiwan, Thailand, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 13, 2005
Enrollment StartAug 1, 2005
Primary CompletionMay 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 20.8 years ago

Interventions

Sestamibidrug

Sestamibi