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 10 years after image completion. The safety of CARDIOLITE® rest and stress heart imaging will also be studied.

Condition	Intervention	Phase
Kawasaki Disease	Drug: Sestamibi	Phase III

Further Study Details: 

Primary Outcomes: The predictive value of test results obtained from Sestamibi myocardial perfusion imaging will be evaluated to define a Kawasaki Disease population at high and low risk of developing cardiac events though 10 years follow-up.
Secondary Outcomes: Concordance will be determined between the presence of perfusion abnormalities detected on Sestamibi images and the classification of ischemic heart disease.; 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.
Expected Total Enrollment:  60

Ages Eligible for Study:  4 Years   -   16 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Males or females between 4 and 16
• Meet the epidemiological definition of Kawasaki Disease
• Be able to exercise adequately to achieve 85% age predicted maximum heart rate

Exclusion Criteria:

• Terminal illness where expected survival is < 6 months

Please refer to this study by ClinicalTrials.gov identifier  NCT00162032

BMS Call Center      1 866 892 1BMS  Ext. 206 

California
      Local Institution, San Diego,  California,  United States; Recruiting
North Carolina
      Local Institution, Greenville,  North Carolina,  United States; Recruiting

Study chairs or principal investigators

Mark Hibberd, MD, PhD,  Study Director,  Bristol-Myers Squibb   

Study ID Numbers:  CARDIOLITE® 301
Last Updated:  September 12, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00162032
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13