Clinical trial NCT00162032: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kawasaki Disease
Lead sponsor: Lantheus Medical Imaging
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 445
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: 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.
timeFrame: 3 years
Secondary outcomes:
measure: Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in Adolescents and Children Versus Coronary Angiography
timeFrame: 6 months
measure: Incidence of Hard Cardiac Events
timeFrame: 3 years
measure: 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
timeFrame: 24 hours
measure: Predictive Value of Cardiolite For Cardiac Events
timeFrame: 6 months
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Local Institution
state: Alaska
city: Little Rock
country: United States
facility: Local Institution
state: Arkansas
city: Los Angeles
country: United States
facility: Local Institution
state: California
city: Orange
country: United States
facility: Local Institution
state: California
city: San Diego
country: United States
facility: Local Institution
state: California
city: Denver
country: United States
facility: Local Institution
state: Colorado
city: Hartford
country: United States
facility: Local Institution
state: Connecticut
city: New Haven
country: United States
facility: Local Institution
state: Connecticut
city: Honolulu
country: United States
facility: Local Institution
state: Hawaii
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: Park Ridge
country: United States
facility: Local Institution
state: Illinois
city: Indianapolis
country: United States
facility: Local Institution
state: Indiana
city: Lexington
country: United States
facility: Local Institution
state: Kentucky
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
city: Las Vegas
country: United States
facility: Local Institution
state: Nevada
city: New Hyde Park
country: United States
facility: Local Institution
state: New York
city: New York
country: United States
facility: Local Institution
state: New York
city: Durham
country: United States
facility: Local Institution
state: North Carolina
city: Greenville
country: United States
facility: Local Institution
state: North Carolina
city: Cincinnati
country: United States
facility: Local Institution
state: Ohio
city: Cleveland
country: United States
facility: Local Institution
state: Ohio
city: Hershey
country: United States
facility: Local Institution
state: Pennsylvania
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution
state: Pennsylvania
city: Charlottesville
country: United States
facility: Local Institution
state: Virginia
city: Seattle
country: United States
facility: Local Institution
state: Washington
city: Spokane
country: United States
facility: Local Institution
state: Washington
city: Milwaukee
country: United States
facility: Local Institution
state: Wisconsin
city: Belo Horizonte
country: Brazil
facility: Local Institution
city: Campinas
country: Brazil
facility: Local Institution
city: Curitiba
country: Brazil
facility: Local Institution
city: Rio de Janeiro
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Halifax
country: Canada
facility: Local Institution
state: Nova Scotia
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Daejeon
country: Korea, Republic of
facility: Local Institution
city: Pusan
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Insitution
city: Suwon
country: Korea, Republic of
facility: Local Institution
city: Wonju
country: Korea, Republic of
facility: Local Institution
city: Quezon City
country: Philippines
facility: Local Institution
city: Changhua
country: Taiwan
facility: Local Institution
city: Kaohsiung
country: Taiwan
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Bangkok
country: Thailand
facility: Local Institution
city: Hat Yai
country: Thailand
facility: Local Institution
Study officials:
affiliation: Lantheus Medical Imaging
name: Qi Zhu, MD,
role: STUDY_DIRECTOR
References: