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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 : December 6, 2013
Sponsor:
Information provided by (Responsible Party):
Lantheus Medical Imaging

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Kawasaki Disease
Intervention Drug: Sestamibi
Enrollment 445
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Children (Ages 4-11) Adolescents (Ages 12-16)
Hide Arm/Group Description Arm A children 4-11 years of age Arm B children 12-16 years of age
Period Title: Overall Study
Started 329 116
Completed 324 [1] 114 [1]
Not Completed 5 2
Reason Not Completed
Lost to Follow-up             4             2
Reason not specified             1             0
[1]
Completed is all subjects who completed 3 yr FU whether or not they were seen in the previous year.
Arm/Group Title Children (Ages 4-11) Adolescents (Ages 12-16) Total
Hide Arm/Group Description Arm A children 4-11 years of age Arm B children 12-16 years of age Total of all reporting groups
Overall Number of Baseline Participants 329 116 445
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 329 participants 116 participants 445 participants
<=18 years
329
 100.0%
116
 100.0%
445
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 329 participants 116 participants 445 participants
7.7  (2.16) 13.6  (1.31) 9.0  (3.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 329 participants 116 participants 445 participants
Female
104
  31.6%
40
  34.5%
144
  32.4%
Male
225
  68.4%
76
  65.5%
301
  67.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 329 participants 116 participants 445 participants
United States 64 39 103
Philippines 33 8 41
Taiwan 85 27 112
Canada 18 17 35
Brazil 34 5 39
Thailand 46 6 52
Korea, Republic of 43 10 53
Singapore 6 4 10
1.Primary Outcome
Title Kawasaki Disease Population at High and Low Risk of Developing Cardiac Events Though Three Years Follow-up.
Hide Description 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.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Had SPECT Myocardial perfusion imaging tests and experienced a cardiac event
Arm/Group Title Children (4 -11 Years) Normal Adolescents (12-16 Years) Normal Children (4-11 Years) Abnormal Adolescents (12-16 Years) Abnormal
Hide Arm/Group Description:
SSS (summed stress score) <=4, low risk
SSS (summed stress score) <4, low risk
SSS (summed stress score)>4, high risk
sss (summed stress score >4, high risk
Overall Number of Participants Analyzed 287 93 26 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.041
(0.015 to 0.066)
0.033
(0.000 to 0.071)
0.115
(0.000 to 0.238)
0.233
(0.000 to 0.493)
2.Secondary Outcome
Title Concordance Will be Determined Between the Presence of Perfusion Abnormalities Detected on Sestamibi Images and the Classification of Ischemic Heart Disease.
Hide Description [Not Specified]
Time Frame 3 year follow up
Outcome Measure Data Not Reported
3.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 3 year follow up
Outcome Measure Data Not Reported
Time Frame AEs within 24+- 12 hours. SAEs up to 14 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Children (Ages 4-11) Adolescents (Ages 12-16)
Hide Arm/Group Description Arm A children 4-11 years of age Arm B adolescents 12-16 years of age
All-Cause Mortality
Children (Ages 4-11) Adolescents (Ages 12-16)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Children (Ages 4-11) Adolescents (Ages 12-16)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/329 (0.30%)      0/116 (0.00%)    
Injury, poisoning and procedural complications     
Overdose * 1 [1]  1/329 (0.30%)  1 0/116 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
[1]
Subject 014-006 was a 5-year old white female. The subject received a total dose of Cardiolite on 05 June 2006 of 16.9 mCi. The nuclear medicine technician incorrectly calculated the doses based on a weight of 40 kg rather 40 lbs (18.1 kg).
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Children (Ages 4-11) Adolescents (Ages 12-16)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/329 (2.43%)      5/116 (4.31%)    
Gastrointestinal disorders     
Nausea * 1  5/329 (1.52%)  5 0/116 (0.00%)  0
Nervous system disorders     
Headache * 1  4/329 (1.22%)  4 5/116 (4.31%)  5
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Qi Zhu, MD
Organization: Lantheus Medical Imaging
Phone: 978-671-8605
Responsible Party: Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT00162032     History of Changes
Other Study ID Numbers: CARDIOLITE® 301
First Submitted: September 9, 2005
First Posted: September 13, 2005
Results First Submitted: April 30, 2013
Results First Posted: December 6, 2013
Last Update Posted: December 6, 2013