Trial Outcomes & Findings for A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease (NCT NCT00162032)
NCT ID: NCT00162032
Last Updated: 2019-07-23
Results Overview
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.
COMPLETED
PHASE3
445 participants
3 years
2019-07-23
Participant Flow
Participant milestones
| Measure |
Children (Ages 4-11)
Arm A children 4-11 years of age
|
Adolescents (Ages 12-16)
Arm B children 12-16 years of age
|
|---|---|---|
|
Overall Study
STARTED
|
329
|
116
|
|
Overall Study
COMPLETED
|
324
|
114
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Children (Ages 4-11)
Arm A children 4-11 years of age
|
Adolescents (Ages 12-16)
Arm B children 12-16 years of age
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
|
Overall Study
Reason not specified
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease
Baseline characteristics by cohort
| Measure |
Children (Ages 4-11)
n=329 Participants
Arm A children 4-11 years of age
|
Adolescents (Ages 12-16)
n=116 Participants
Arm B children 12-16 years of age
|
Total
n=445 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
329 Participants
n=93 Participants
|
116 Participants
n=4 Participants
|
445 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
7.7 years
STANDARD_DEVIATION 2.16 • n=93 Participants
|
13.6 years
STANDARD_DEVIATION 1.31 • n=4 Participants
|
9.0 years
STANDARD_DEVIATION 3.27 • n=27 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
144 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
225 Participants
n=93 Participants
|
76 Participants
n=4 Participants
|
301 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=93 Participants
|
39 participants
n=4 Participants
|
103 participants
n=27 Participants
|
|
Region of Enrollment
Philippines
|
33 participants
n=93 Participants
|
8 participants
n=4 Participants
|
41 participants
n=27 Participants
|
|
Region of Enrollment
Taiwan
|
85 participants
n=93 Participants
|
27 participants
n=4 Participants
|
112 participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
18 participants
n=93 Participants
|
17 participants
n=4 Participants
|
35 participants
n=27 Participants
|
|
Region of Enrollment
Brazil
|
34 participants
n=93 Participants
|
5 participants
n=4 Participants
|
39 participants
n=27 Participants
|
|
Region of Enrollment
Thailand
|
46 participants
n=93 Participants
|
6 participants
n=4 Participants
|
52 participants
n=27 Participants
|
|
Region of Enrollment
Korea, Republic of
|
43 participants
n=93 Participants
|
10 participants
n=4 Participants
|
53 participants
n=27 Participants
|
|
Region of Enrollment
Singapore
|
6 participants
n=93 Participants
|
4 participants
n=4 Participants
|
10 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Had SPECT Myocardial perfusion imaging tests and experienced a cardiac event
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.
Outcome measures
| Measure |
Children (4 -11 Years) Normal
n=287 Participants
SSS (summed stress score) \<=4, low risk
|
Adolescents (12-16 Years) Normal
n=93 Participants
SSS (summed stress score) \<4, low risk
|
Children (4-11 Years) Abnormal
n=26 Participants
SSS (summed stress score)\>4, high risk
|
Adolescents (12-16 Years) Abnormal
n=19 Participants
sss (summed stress score \>4, high risk
|
|---|---|---|---|---|
|
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.
|
0.041 proportion of participants
Interval 0.015 to 0.066
|
0.033 proportion of participants
Interval 0.0 to 0.071
|
0.115 proportion of participants
Interval 0.0 to 0.238
|
0.233 proportion of participants
Interval 0.0 to 0.493
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Per-protocol population of pooled adolescents and children who underwent coronary angiography
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.
Outcome measures
| Measure |
Children (4 -11 Years) Normal
n=50 Participants
SSS (summed stress score) \<=4, low risk
|
Adolescents (12-16 Years) Normal
SSS (summed stress score) \<4, low risk
|
Children (4-11 Years) Abnormal
SSS (summed stress score)\>4, high risk
|
Adolescents (12-16 Years) Abnormal
sss (summed stress score \>4, high risk
|
|---|---|---|---|---|
|
Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in Adolescents and Children Versus Coronary Angiography
Sensitivity
|
0.35 proportion
Interval 0.11 to 0.69
|
—
|
—
|
—
|
|
Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in Adolescents and Children Versus Coronary Angiography
Specificity
|
0.62 proportion
Interval 0.45 to 0.77
|
—
|
—
|
—
|
|
Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in Adolescents and Children Versus Coronary Angiography
Positive Predictive Value
|
0.21 proportion
Interval 0.06 to 0.46
|
—
|
—
|
—
|
|
Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in Adolescents and Children Versus Coronary Angiography
Negative Predictive Value
|
0.77 proportion
Interval 0.59 to 0.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: All subjects who had undergone stress cardiac MPI studies
Examine the incidence of hard cardiac events (myocardial infarction \[MI\] or cardiac death) in KD subjects with positive and negative MPI scans.
Outcome measures
| Measure |
Children (4 -11 Years) Normal
n=287 Participants
SSS (summed stress score) \<=4, low risk
|
Adolescents (12-16 Years) Normal
n=93 Participants
SSS (summed stress score) \<4, low risk
|
Children (4-11 Years) Abnormal
n=26 Participants
SSS (summed stress score)\>4, high risk
|
Adolescents (12-16 Years) Abnormal
n=19 Participants
sss (summed stress score \>4, high risk
|
|---|---|---|---|---|
|
Incidence of Hard Cardiac Events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 24 hoursSensitivity, 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.
Outcome measures
| Measure |
Children (4 -11 Years) Normal
n=29 Participants
SSS (summed stress score) \<=4, low risk
|
Adolescents (12-16 Years) Normal
n=22 Participants
SSS (summed stress score) \<4, low risk
|
Children (4-11 Years) Abnormal
SSS (summed stress score)\>4, high risk
|
Adolescents (12-16 Years) Abnormal
sss (summed stress score \>4, high risk
|
|---|---|---|---|---|
|
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
Sensitivity
|
.25 proportion
Interval 0.01 to 0.81
|
0.00 proportion
Interval 0.0 to 0.71
|
—
|
—
|
|
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
Specificity
|
0.76 proportion
Interval 0.55 to 0.91
|
0.74 proportion
Interval 0.49 to 0.91
|
—
|
—
|
|
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
Positive Predictive Value
|
0.14 proportion
Interval 0.0 to 0.58
|
0.00 proportion
Interval 0.0 to 0.52
|
—
|
—
|
|
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
Negative Predictive Value
|
0.86 proportion
Interval 0.65 to 0.97
|
0.82 proportion
Interval 0.57 to 0.96
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Efficacy Evaluable Population
Determine the incidence of cardiac events occurring over a 6 month follow up period in pediatric subjects with normal myocardial perfusion scans.
Outcome measures
| Measure |
Children (4 -11 Years) Normal
n=287 Participants
SSS (summed stress score) \<=4, low risk
|
Adolescents (12-16 Years) Normal
n=93 Participants
SSS (summed stress score) \<4, low risk
|
Children (4-11 Years) Abnormal
n=26 Participants
SSS (summed stress score)\>4, high risk
|
Adolescents (12-16 Years) Abnormal
n=19 Participants
sss (summed stress score \>4, high risk
|
|---|---|---|---|---|
|
Predictive Value of Cardiolite For Cardiac Events
|
3 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
Adverse Events
Children (Ages 4-11)
Adolescents (Ages 12-16)
Serious adverse events
| Measure |
Children (Ages 4-11)
n=329 participants at risk
Arm A children 4-11 years of age
|
Adolescents (Ages 12-16)
n=116 participants at risk
Arm B adolescents 12-16 years of age
|
|---|---|---|
|
Injury, poisoning and procedural complications
Overdose
|
0.30%
1/329 • Number of events 1 • AEs within 24+- 12 hours. SAEs up to 14 days.
|
0.00%
0/116 • AEs within 24+- 12 hours. SAEs up to 14 days.
|
Other adverse events
| Measure |
Children (Ages 4-11)
n=329 participants at risk
Arm A children 4-11 years of age
|
Adolescents (Ages 12-16)
n=116 participants at risk
Arm B adolescents 12-16 years of age
|
|---|---|---|
|
Nervous system disorders
Headache
|
1.2%
4/329 • Number of events 4 • AEs within 24+- 12 hours. SAEs up to 14 days.
|
4.3%
5/116 • Number of events 5 • AEs within 24+- 12 hours. SAEs up to 14 days.
|
|
Gastrointestinal disorders
Nausea
|
1.5%
5/329 • Number of events 5 • AEs within 24+- 12 hours. SAEs up to 14 days.
|
0.00%
0/116 • AEs within 24+- 12 hours. SAEs up to 14 days.
|
Additional Information
Cesare Orlandi, MD, Chief Medical Officer
Lantheus Medical Imaging
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60