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

Sponsors

Lead Sponsor: Lantheus Medical Imaging

Source 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.

Overall Status Completed
Start Date August 2005
Completion Date December 2010
Primary Completion Date May 2010
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure 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. 3 years
Secondary Outcome
Measure Time Frame
Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in Adolescents and Children Versus Coronary Angiography 6 months
Incidence of Hard Cardiac Events 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 24 hours
Predictive Value of Cardiolite For Cardiac Events 6 months
Enrollment 445
Condition
Intervention

Intervention Type: Drug

Intervention Name: Sestamibi

Description: Sestamibi

Other Name: Cardiolite

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

Minimum Age: 4 Years

Maximum Age: 16 Years

Healthy Volunteers: No

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

Brazil

Canada

Korea, Republic of

Philippines

Taiwan

Thailand

United States

Verification Date

July 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Children (Ages 4-11)

Type: Other

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

Label: Adolescents (Ages 12-16)

Type: Other

Description: Adolescents 12-16 years of age, intervention Sestamibi

Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov