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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 : July 23, 2019
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. 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. [ 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. Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in Adolescents and Children Versus Coronary Angiography [ Time Frame: 6 months ]
    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.

  2. Incidence of Hard Cardiac Events [ Time Frame: 3 years ]
    Examine the incidence of hard cardiac events (myocardial infarction [MI] or cardiac death) in KD subjects with positive and negative MPI scans.

  3. 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 [ Time Frame: 24 hours ]
    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.

  4. Predictive Value of Cardiolite For Cardiac Events [ Time Frame: 6 months ]
    Determine the incidence of cardiac events occurring over a 6 month follow up period in pediatric subjects with normal myocardial perfusion scans.



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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


Locations
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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    
Other Study ID Numbers: CARDIOLITE® 301
First Posted: September 13, 2005    Key Record Dates
Results First Posted: December 6, 2013
Last Update Posted: July 23, 2019
Last Verified: July 2019
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