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

Phase 3

Completed

• Conditions: Kawasaki Disease
• Interventions: Drug: Sestamibi

• Registration Number: NCT00162032
• Lead Sponsor: Lantheus Medical Imaging

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-13
• Primary Completion: 2010-05
• Study Completion: 2010-12
• Results First Submitted: 2013-04-30
• Results First Submitted QC: 2013-10-08
• Results First Posted: 2013-12-06
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 445

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

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Exclusion Criteria

• Terminal illness where expected survival is < 6 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Children (Ages 4-11)	Sestamibi	Children 4-11 years of age, intervention Sestamibi
Adolescents (Ages 12-16)	Sestamibi	Adolescents 12-16 years of age, intervention Sestamibi

Primary Outcome Measures

Name	Time	Method
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.	3 years	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.

Secondary Outcome Measures

Name	Time	Method
Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in Adolescents and Children Versus Coronary Angiography	6 months	Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of myocardial perfusion imaging (MPI) for the diagnosis of ischemic heart disease (IHD) relative to coronary angiography. Coronary stenoses of ≥ 50% were classified as disease. SSS \> 4 in MPI was classified as positive for IHD.
Predictive Value of Cardiolite For Cardiac Events	6 months	Determine the incidence of cardiac events occurring over a 6 month follow up period in pediatric subjects with normal myocardial perfusion scans.
Incidence of Hard Cardiac Events	3 years	Examine the incidence of hard cardiac events (myocardial infarction \[MI\] or cardiac death) in KD subjects with positive and negative MPI scans.
Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in the Left Anterior Descending (LAD) Artery in Adolescents and Children Versus Coronary Angiography	24 hours	Sensitivity, specificity, PPV, and NPV of SDS for myocardial perfusion corresponding to the left anterior descending (LAD) for the diagnosis of IHD in the distribution of the left anterior descending (LAD) artery relative to coronary angiography based diagnosis were determined. Coronary stenoses of ≥ 50% for arteries associated with LAD territories were classified as LAD disease. SDS LAD \> 1 was classified as positive for IHD for the LAD distribution.

Trial Locations

Locations (2)

Local Institution; 🇹🇭 Hat Yai, Thailand

Local Insitution; 🇰🇷 Seoul, Korea, Republic of