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

NCT ID: NCT00162032

Last Updated: 2019-07-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

445 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Kawasaki Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Children (Ages 4-11)

Children 4-11 years of age, intervention Sestamibi

Group Type OTHER

Sestamibi

Intervention Type DRUG

Sestamibi

Adolescents (Ages 12-16)

Adolescents 12-16 years of age, intervention Sestamibi

Group Type OTHER

Sestamibi

Intervention Type DRUG

Sestamibi

Interventions

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Sestamibi

Sestamibi

Intervention Type DRUG

Other Intervention Names

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Cardiolite

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lantheus Medical Imaging

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qi Zhu, MD,

Role: STUDY_DIRECTOR

Lantheus Medical Imaging

Locations

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Local Institution

Anchorage, Alaska, United States

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Little Rock, Arkansas, United States

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Los Angeles, California, United States

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Orange, California, United States

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San Diego, California, United States

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Denver, Colorado, United States

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Hartford, Connecticut, United States

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New Haven, Connecticut, United States

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Honolulu, Hawaii, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Park Ridge, Illinois, United States

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Indianapolis, Indiana, United States

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Lexington, Kentucky, United States

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Boston, Massachusetts, United States

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Las Vegas, Nevada, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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Durham, North Carolina, United States

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Greenville, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charlottesville, Virginia, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Milwaukee, Wisconsin, United States

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Belo Horizonte, , Brazil

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Campinas, , Brazil

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Curitiba, , Brazil

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Rio de Janeiro, , Brazil

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São Paulo, , Brazil

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Vancouver, British Columbia, Canada

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Halifax, Nova Scotia, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Quezon City, , Philippines

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Daejeon, , South Korea

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Pusan, , South Korea

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Seoul, , South Korea

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Suwon, , South Korea

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Wŏnju, , South Korea

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Changhua, , Taiwan

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Kaohsiung City, , Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

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Bangkok, , Thailand

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Hat Yai, , Thailand

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Countries

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United States Brazil Canada Philippines South Korea Taiwan Thailand

Other Identifiers

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CARDIOLITE® 301

Identifier Type: -

Identifier Source: org_study_id

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