NCT00162032

A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 445 (actual)
• Sponsor: Lantheus Medical Imaging · Industry
• Sex: All
• Age: 4 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this clinical research study is to determine how well CARDIOLITE® rest and stress myocardial (heart) imaging can define the pediatric Kawasaki disease (KD) population into high and low risk categories of developing cardiac (heart) events (complications) from 1 year through 3 years after image completion. The safety of CARDIOLITE® rest and stress heart imaging will also be studied.

Conditions

• Kawasaki Disease

Interventions

Type	Name	Description
DRUG	Sestamibi	Sestamibi

Timeline

• Start date: 2005-08-01
• Primary completion: 2010-05-01
• Completion: 2010-12-01
• First posted: 2005-09-13
• Last updated: 2019-07-23
• Results posted: 2013-12-06

Locations

50 sites across 7 countries: United States, Brazil, Canada, Philippines, South Korea, Taiwan, Thailand