Overview

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

Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Lantheus Medical Imaging
Treatments:
Technetium Tc 99m Sestamibi
Criteria
Inclusion Criteria:

- Males or females between 4 and 16

- Meet the epidemiological definition of Kawasaki Disease or have a diagnosis of
incomplete KD, including evidence of coronary artery disease as determined by their
physician.

- Be able to exercise adequately to achieve 85% age predicted maximum heart rate

Exclusion Criteria:

- Terminal illness where expected survival is < 6 months