Kawasaki Disease
Conditions
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.
Interventions
DRUGSestamibi
Sestamibi
Sponsors
Lantheus Medical Imaging
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in Adolescents and Children Versus Coronary Angiography | 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 | 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 | 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 | 6 months | Determine the incidence of cardiac events occurring over a 6 month follow up period in pediatric subjects with normal myocardial perfusion scans. |
Countries
Brazil, Canada, Philippines, South Korea, Taiwan, Thailand, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Children (Ages 4-11) Arm A children 4-11 years of age | 329 |
| Adolescents (Ages 12-16) Arm B children 12-16 years of age | 116 |
| Total | 445 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 2 |
| Overall Study | Reason not specified | 1 | 0 |
Baseline characteristics
| Characteristic | Children (Ages 4-11) | Adolescents (Ages 12-16) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 329 Participants | 116 Participants | 445 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 7.7 years STANDARD_DEVIATION 2.16 | 13.6 years STANDARD_DEVIATION 1.31 | 9.0 years STANDARD_DEVIATION 3.27 |
| Region of Enrollment Brazil | 34 participants | 5 participants | 39 participants |
| Region of Enrollment Canada | 18 participants | 17 participants | 35 participants |
| Region of Enrollment Korea, Republic of | 43 participants | 10 participants | 53 participants |
| Region of Enrollment Philippines | 33 participants | 8 participants | 41 participants |
| Region of Enrollment Singapore | 6 participants | 4 participants | 10 participants |
| Region of Enrollment Taiwan | 85 participants | 27 participants | 112 participants |
| Region of Enrollment Thailand | 46 participants | 6 participants | 52 participants |
| Region of Enrollment United States | 64 participants | 39 participants | 103 participants |
| Sex: Female, Male Female | 104 Participants | 40 Participants | 144 Participants |
| Sex: Female, Male Male | 225 Participants | 76 Participants | 301 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 329 | 5 / 116 |
| serious Total, serious adverse events | 1 / 329 | 0 / 116 |
Outcome results
Primary
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.
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
Population: Had SPECT Myocardial perfusion imaging tests and experienced a cardiac event
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Children (4 -11 Years) Normal | 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 |
| Adolescents (12-16 Years) Normal | 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. | 0.033 proportion of participants |
| Children (4-11 Years) Abnormal | 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. | 0.115 proportion of participants |
| Adolescents (12-16 Years) Abnormal | 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. | 0.233 proportion of participants |
Secondary
Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in Adolescents and Children Versus 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.
Time frame: 6 months
Population: Per-protocol population of pooled adolescents and children who underwent coronary angiography
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Children (4 -11 Years) Normal | 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 |
| Children (4 -11 Years) Normal | 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 |
| Children (4 -11 Years) Normal | 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 |
| Children (4 -11 Years) Normal | 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 |
Secondary
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, 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.
Time frame: 24 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Children (4 -11 Years) Normal | 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 |
| Children (4 -11 Years) Normal | 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 |
| Children (4 -11 Years) Normal | 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 |
| Children (4 -11 Years) Normal | 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 |
| Adolescents (12-16 Years) Normal | 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 | 0.82 proportion |
| Adolescents (12-16 Years) Normal | 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 | 0.00 proportion |
| Adolescents (12-16 Years) Normal | 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 | 0.00 proportion |
| Adolescents (12-16 Years) Normal | 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 | 0.74 proportion |
Secondary
Incidence of Hard Cardiac Events
Examine the incidence of hard cardiac events (myocardial infarction \[MI\] or cardiac death) in KD subjects with positive and negative MPI scans.
Time frame: 3 years
Population: All subjects who had undergone stress cardiac MPI studies
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Children (4 -11 Years) Normal | Incidence of Hard Cardiac Events | 0 participants |
| Adolescents (12-16 Years) Normal | Incidence of Hard Cardiac Events | 0 participants |
| Children (4-11 Years) Abnormal | Incidence of Hard Cardiac Events | 0 participants |
| Adolescents (12-16 Years) Abnormal | Incidence of Hard Cardiac Events | 0 participants |
Secondary
Predictive Value of Cardiolite For Cardiac Events
Determine the incidence of cardiac events occurring over a 6 month follow up period in pediatric subjects with normal myocardial perfusion scans.
Time frame: 6 months
Population: Efficacy Evaluable Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Children (4 -11 Years) Normal | Predictive Value of Cardiolite For Cardiac Events | 3 Participants |
| Adolescents (12-16 Years) Normal | Predictive Value of Cardiolite For Cardiac Events | 1 Participants |
| Children (4-11 Years) Abnormal | Predictive Value of Cardiolite For Cardiac Events | 3 Participants |
| Adolescents (12-16 Years) Abnormal | Predictive Value of Cardiolite For Cardiac Events | 2 Participants |