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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00162032
Recruitment Status : Completed
First Posted : September 13, 2005
Results First Posted : December 6, 2013
Last Update Posted : December 6, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Kawasaki Disease Drug: Sestamibi Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 445 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : August 2005
Actual Primary Completion Date : May 2010
Actual Study Completion Date : December 2010


Arm Intervention/treatment
Children (Ages 4-11)
Children 4-11 years of age, intervention Sestamibi
Drug: Sestamibi
Sestamibi
Other Name: Cardiolite

Adolescents (Ages 12-16)
Adolescents 12-16 years of age, intervention Sestamibi
Drug: Sestamibi
Sestamibi
Other Name: Cardiolite




Primary Outcome Measures :
  1. Kawasaki Disease Population at High and Low Risk of Developing Cardiac Events Though Three Years Follow-up. [ Time Frame: 3 years ]
    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 :
  1. Concordance Will be Determined Between the Presence of Perfusion Abnormalities Detected on Sestamibi Images and the Classification of Ischemic Heart Disease. [ Time Frame: 3 year follow up ]
  2. In Addition, a Determination of the Safety of Sestamibi Will be Evaluated at the End of the Study Through Adverse and Serious Adverse Events Reported and Evaluating Vital Signs, ECGs, Physical Exams and Laboratory Tests for Each Subject. [ Time Frame: 3 year follow up ]


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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162032


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

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Responsible Party: Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT00162032     History of Changes
Other Study ID Numbers: CARDIOLITE® 301
First Posted: September 13, 2005    Key Record Dates
Results First Posted: December 6, 2013
Last Update Posted: December 6, 2013
Last Verified: April 2012

Additional relevant MeSH terms:
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Mucocutaneous Lymph Node Syndrome
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
Technetium Tc 99m Sestamibi
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action