A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease
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|ClinicalTrials.gov Identifier: NCT00162032|
Recruitment Status : Completed
First Posted : September 13, 2005
Results First Posted : December 6, 2013
Last Update Posted : July 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Kawasaki Disease||Drug: Sestamibi||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||445 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Children (Ages 4-11)
Children 4-11 years of age, intervention Sestamibi
Other Name: Cardiolite
Adolescents (Ages 12-16)
Adolescents 12-16 years of age, intervention Sestamibi
Other Name: Cardiolite
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Study Director:||Qi Zhu, MD,||Lantheus Medical Imaging|