Status:
COMPLETED
A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease
Lead Sponsor:
Lantheus Medical Imaging
Conditions:
Kawasaki Disease
Eligibility:
All Genders
4-16 years
Phase:
PHASE3
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- Terminal illness where expected survival is \< 6 months
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
445 Patients enrolled
Trial Details
Trial ID
NCT00162032
Start Date
August 1 2005
End Date
December 1 2010
Last Update
July 23 2019
Active Locations (50)
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1
Local Institution
Anchorage, Alaska, United States, 99508
2
Local Institution
Little Rock, Arkansas, United States, 72202
3
Local Institution
Los Angeles, California, United States, 90027
4
Local Institution
Orange, California, United States, 92868