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

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Brief Title

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

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

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 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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Determine the Predictive Value of Cardiolite® Rest and Stress MPI to Define Pediatric Populations With Kawasaki Disease at High and Low Risk of Developing Cardiac Events.

Secondary Outcome

 Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in Adolescents and Children Versus Coronary Angiography

Condition

Kawasaki Disease

Intervention

Sestamibi

Study Arms / Comparison Groups

 Children (Ages 4-11)
Description:  Children 4-11 years of age, intervention Sestamibi

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

445

Start Date

August 2005

Completion Date

December 2010

Primary Completion Date

May 2010

Eligibility 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
      

Gender

All

Ages

4 Years - 16 Years

Accepts Healthy Volunteers

No

Contacts

Qi Zhu, MD,, , 

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations


NCT ID

NCT00162032

Organization ID

CARDIOLITE® 301


Responsible Party

Sponsor

Study Sponsor

Lantheus Medical Imaging


Study Sponsor

Qi Zhu, MD,, Study Director, Lantheus Medical Imaging


Verification Date

July 2019