Back to resultsA Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease
Primary Purpose
Kawasaki Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sestamibi
Sponsored by
About this trial
This is an interventional diagnostic trial for Kawasaki Disease
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
Sites / Locations
- Local Institution
- Local Institution
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- Local Institution
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- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Insitution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Children (Ages 4-11)
Adolescents (Ages 12-16)
Arm Description
Children 4-11 years of age, intervention Sestamibi
Adolescents 12-16 years of age, intervention Sestamibi
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT00162032
First Posted
September 9, 2005
Last Updated
July 2, 2019
Sponsor
Lantheus Medical Imaging
1. Study Identification
Unique Protocol Identification Number
NCT00162032
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lantheus Medical Imaging
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kawasaki Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
445 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Children (Ages 4-11)
Arm Type
Other
Arm Description
Children 4-11 years of age, intervention Sestamibi
Arm Title
Adolescents (Ages 12-16)
Arm Type
Other
Arm Description
Adolescents 12-16 years of age, intervention Sestamibi
Intervention Type
Drug
Intervention Name(s)
Sestamibi
Other Intervention Name(s)
Cardiolite
Intervention Description
Sestamibi
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in Adolescents and Children Versus Coronary Angiography
Description
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.
Time Frame
6 months
Title
Incidence of Hard Cardiac Events
Description
Examine the incidence of hard cardiac events (myocardial infarction [MI] or cardiac death) in KD subjects with positive and negative MPI scans.
Time Frame
3 years
Title
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
Description
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.
Time Frame
24 hours
Title
Predictive Value of Cardiolite For Cardiac Events
Description
Determine the incidence of cardiac events occurring over a 6 month follow up period in pediatric subjects with normal myocardial perfusion scans.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qi Zhu, MD,
Organizational Affiliation
Lantheus Medical Imaging
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Local Institution
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Local Institution
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Local Institution
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Local Institution
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Local Institution
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Local Institution
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Local Institution
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Local Institution
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Local Institution
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Local Institution
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Local Institution
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Local Institution
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46201
Country
United States
Facility Name
Local Institution
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Local Institution
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Local Institution
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Local Institution
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Local Institution
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Local Institution
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
Local Institution
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Local Institution
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44101
Country
United States
Facility Name
Local Institution
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Local Institution
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Local Institution
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Local Institution
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22906
Country
United States
Facility Name
Local Institution
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Local Institution
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Local Institution
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53203
Country
United States
Facility Name
Local Institution
City
Belo Horizonte
Country
Brazil
Facility Name
Local Institution
City
Campinas
Country
Brazil
Facility Name
Local Institution
City
Curitiba
Country
Brazil
Facility Name
Local Institution
City
Rio de Janeiro
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
Country
Brazil
Facility Name
Local Institution
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Local Institution
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Local Institution
City
Daejeon
Country
Korea, Republic of
Facility Name
Local Institution
City
Pusan
Country
Korea, Republic of
Facility Name
Local Insitution
City
Seoul
Country
Korea, Republic of
Facility Name
Local Institution
City
Suwon
Country
Korea, Republic of
Facility Name
Local Institution
City
Wonju
Country
Korea, Republic of
Facility Name
Local Institution
City
Quezon City
Country
Philippines
Facility Name
Local Institution
City
Changhua
Country
Taiwan
Facility Name
Local Institution
City
Kaohsiung
Country
Taiwan
Facility Name
Local Institution
City
Taichung
Country
Taiwan
Facility Name
Local Institution
City
Taipei
Country
Taiwan
Facility Name
Local Institution
City
Bangkok
Country
Thailand
Facility Name
Local Institution
City
Hat Yai
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease
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