A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||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|
- Kawasaki Disease Population at High and Low Risk of Developing Cardiac Events Though Three Years Follow-up. [ Time Frame: 3 years ] [ Designated as safety issue: No ]The proportion of all patients who experienced cardiac events among patients with abnormal (SSS >=4, high risk) and normal (SSS <4, low risk) Cardiolite MPI scans during the follow-up period. A log-rank statistic (2-sided, alpha = 0.05) was computed to compare cardiac event-free survival in the high risk and low risk groups. The cardiac event rate is the cumulative event rate based on a Kaplan-Meier estimate conditional on the SPECT MPI score result.
- Concordance Will be Determined Between the Presence of Perfusion Abnormalities Detected on Sestamibi Images and the Classification of Ischemic Heart Disease. [ Time Frame: 3 year follow up ] [ Designated as safety issue: No ]
- In Addition, a Determination of the Safety of Sestamibi Will be Evaluated at the End of the Study Through Adverse and Serious Adverse Events Reported and Evaluating Vital Signs, ECGs, Physical Exams and Laboratory Tests for Each Subject. [ Time Frame: 3 year follow up ] [ Designated as safety issue: No ]
|Study Start Date:||August 2005|
|Study Completion Date:||December 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Children (Ages 4-11)
Children 4-11 years of age, intervention Sestamibi
Other Name: Cardiolite
Adolescents (Ages 12-16)
Adolescents 12-16 years of age, intervention Sestamibi
Other Name: Cardiolite
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.
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|Study Director:||Qi Zhu, MD,||Lantheus Medical Imaging|