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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

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 13, 2005
Results First Submitted Date  ICMJE April 30, 2013
Results First Posted Date  ICMJE December 6, 2013
Last Update Posted Date December 6, 2013
Study Start Date  ICMJE August 2005
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
The predictive value of test results obtained from Sestamibi myocardial perfusion imaging will be evaluated to define a Kawasaki Disease population at high and low risk of developing cardiac events though 10 years follow-up.
Change History Complete list of historical versions of study NCT00162032 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2013)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • Concordance Will be Determined Between the Presence of Perfusion Abnormalities Detected on Sestamibi Images and the Classification of Ischemic Heart Disease.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Kawasaki Disease
Intervention  ICMJE Drug: Sestamibi
Sestamibi
Other Name: Cardiolite
Study Arms  ICMJE
  • Children (Ages 4-11)
    Children 4-11 years of age, intervention Sestamibi
    Intervention: Drug: Sestamibi
  • Adolescents (Ages 12-16)
    Adolescents 12-16 years of age, intervention Sestamibi
    Intervention: Drug: Sestamibi
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 8, 2013)
445
Original Enrollment  ICMJE
 (submitted: September 9, 2005)
60
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Canada,   Korea, Republic of,   Philippines,   Taiwan,   Thailand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00162032
Other Study ID Numbers  ICMJE CARDIOLITE® 301
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lantheus Medical Imaging
Study Sponsor  ICMJE Lantheus Medical Imaging
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Qi Zhu, MD, Lantheus Medical Imaging
PRS Account Lantheus Medical Imaging
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP