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

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

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 Overview

• Status: Completed
• Conditions: Kawasaki Disease
• Intervention / Treatment: Drug: Sestamibi

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 Type: Interventional
• Enrollment (Actual): 445
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Belo Horizonte, Brazil
    • Local Institution
  • Campinas, Brazil
    • Local Institution
  • Curitiba, Brazil
    • Local Institution
  • Rio de Janeiro, Brazil
    • Local Institution
  • Sao Paulo, Brazil
    • Local Institution
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Local Institution
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Local Institution
  • Ontario
    • Toronto, Ontario, Canada
      • Local Institution
  • Quebec
    • Montreal, Quebec, Canada
      • Local Institution
• Korea, Republic of
  • Daejeon, Korea, Republic of
    • Local Institution
  • Pusan, Korea, Republic of
    • Local Institution
  • Seoul, Korea, Republic of
    • Local Insitution
  • Suwon, Korea, Republic of
    • Local Institution
  • Wonju, Korea, Republic of
    • Local Institution
• Philippines
  • Quezon City, Philippines
    • Local Institution
• Taiwan
  • Changhua, Taiwan
    • Local Institution
  • Kaohsiung, Taiwan
    • Local Institution
  • Taichung, Taiwan
    • Local Institution
  • Taipei, Taiwan
    • Local Institution
• Thailand
  • Bangkok, Thailand
    • Local Institution
  • Hat Yai, Thailand
    • Local Institution
• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Local Institution
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Local Institution
  • California
    • Los Angeles, California, United States, 90027
      • Local Institution
    • Orange, California, United States, 92868
      • Local Institution
    • San Diego, California, United States, 92123
      • Local Institution
  • Colorado
    • Denver, Colorado, United States, 80218
      • Local Institution
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Local Institution
    • New Haven, Connecticut, United States, 06511
      • Local Institution
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Local Institution
  • Illinois
    • Chicago, Illinois, United States, 60614
      • Local Institution
    • Chicago, Illinois, United States, 60637
      • Local Institution
    • Park Ridge, Illinois, United States, 60068
      • Local Institution
  • Indiana
    • Indianapolis, Indiana, United States, 46201
      • Local Institution
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Local Institution
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Local Institution
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Local Institution
  • New York
    • New Hyde Park, New York, United States, 11040
      • Local Institution
    • New York, New York, United States, 10032
      • Local Institution
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Local Institution
    • Greenville, North Carolina, United States, 27858
      • Local Institution
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Local Institution
    • Cleveland, Ohio, United States, 44101
      • Local Institution
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Local Institution
    • Philadelphia, Pennsylvania, United States, 19107
      • Local Institution
    • Pittsburgh, Pennsylvania, United States, 15213
      • Local Institution
  • Virginia
    • Charlottesville, Virginia, United States, 22906
      • Local Institution
  • Washington
    • Seattle, Washington, United States, 98105
      • Local Institution
    • Spokane, Washington, United States, 99204
      • Local Institution
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53203
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Children (Ages 4-11); Children 4-11 years of age, intervention Sestamibi	Drug: Sestamibi; Sestamibi; Other Names: Cardiolite
Other: Adolescents (Ages 12-16); Adolescents 12-16 years of age, intervention Sestamibi	Drug: Sestamibi; Sestamibi; Other Names: Cardiolite

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in Adolescents and Children Versus Coronary Angiography	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.	6 months
Incidence of Hard Cardiac Events	Examine the incidence of hard cardiac events (myocardial infarction [MI] or cardiac death) in KD subjects with positive and negative MPI scans.	3 years
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	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.	24 hours
Predictive Value of Cardiolite For Cardiac Events	Determine the incidence of cardiac events occurring over a 6 month follow up period in pediatric subjects with normal myocardial perfusion scans.	6 months

Collaborators and Investigators

• Sponsor: Lantheus Medical Imaging
• Investigators: Study Director: Qi Zhu, MD,, Lantheus Medical Imaging

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 9, 2005
• First Posted (Estimate): September 13, 2005

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Lymphatic Diseases; Vasculitis; Skin Diseases, Vascular; Mucocutaneous Lymph Node Syndrome; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Technetium Tc 99m Sestamibi
• Other Study ID Numbers: CARDIOLITE® 301