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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children (Ages 4-11) | Other | Children 4-11 years of age, intervention Sestamibi |
|
| Adolescents (Ages 12-16) | Other | Adolescents 12-16 years of age, intervention Sestamibi |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sestamibi | Drug | Sestamibi |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qi Zhu, MD, | Lantheus Medical Imaging | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Anchorage | Alaska | 99508 | United States | ||
| Local Institution |
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| ID | Title | Description |
|---|---|---|
| FG000 | Children (Ages 4-11) | Arm A children 4-11 years of age |
| FG001 | Adolescents (Ages 12-16) | Arm B children 12-16 years of age |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 6 months |
| 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. | 3 years |
| 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. | 24 hours |
| 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. | 6 months |
| Little Rock |
| Arkansas |
| 72202 |
| United States |
| Local Institution | Los Angeles | California | 90027 | United States |
| Local Institution | Orange | California | 92868 | United States |
| Local Institution | San Diego | California | 92123 | United States |
| Local Institution | Denver | Colorado | 80218 | United States |
| Local Institution | Hartford | Connecticut | 06106 | United States |
| Local Institution | New Haven | Connecticut | 06511 | United States |
| Local Institution | Honolulu | Hawaii | 96813 | United States |
| Local Institution | Chicago | Illinois | 60614 | United States |
| Local Institution | Chicago | Illinois | 60637 | United States |
| Local Institution | Park Ridge | Illinois | 60068 | United States |
| Local Institution | Indianapolis | Indiana | 46201 | United States |
| Local Institution | Lexington | Kentucky | 40536 | United States |
| Local Institution | Boston | Massachusetts | 02111 | United States |
| Local Institution | Las Vegas | Nevada | 89109 | United States |
| Local Institution | New Hyde Park | New York | 11040 | United States |
| Local Institution | New York | New York | 10032 | United States |
| Local Institution | Durham | North Carolina | 27710 | United States |
| Local Institution | Greenville | North Carolina | 27858 | United States |
| Local Institution | Cincinnati | Ohio | 45229 | United States |
| Local Institution | Cleveland | Ohio | 44101 | United States |
| Local Institution | Hershey | Pennsylvania | 17033 | United States |
| Local Institution | Philadelphia | Pennsylvania | 19107 | United States |
| Local Institution | Pittsburgh | Pennsylvania | 15213 | United States |
| Local Institution | Charlottesville | Virginia | 22906 | United States |
| Local Institution | Seattle | Washington | 98105 | United States |
| Local Institution | Spokane | Washington | 99204 | United States |
| Local Institution | Milwaukee | Wisconsin | 53203 | United States |
| Local Institution | Belo Horizonte | Brazil |
| Local Institution | Campinas | Brazil |
| Local Institution | Curitiba | Brazil |
| Local Institution | Rio de Janeiro | Brazil |
| Local Institution | São Paulo | Brazil |
| Local Institution | Vancouver | British Columbia | Canada |
| Local Institution | Halifax | Nova Scotia | Canada |
| Local Institution | Toronto | Ontario | Canada |
| Local Institution | Montreal | Quebec | Canada |
| Local Institution | Quezon City | Philippines |
| Local Institution | Daejeon | South Korea |
| Local Institution | Pusan | South Korea |
| Local Insitution | Seoul | South Korea |
| Local Institution | Suwon | South Korea |
| Local Institution | Wŏnju | South Korea |
| Local Institution | Changhua | Taiwan |
| Local Institution | Kaohsiung City | Taiwan |
| Local Institution | Taichung | Taiwan |
| Local Institution | Taipei | Taiwan |
| Local Institution | Bangkok | Thailand |
| Local Institution | Hat Yai | Thailand |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Children (Ages 4-11) | Arm A children 4-11 years of age |
| BG001 | Adolescents (Ages 12-16) | Arm B children 12-16 years of age |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Had SPECT Myocardial perfusion imaging tests and experienced a cardiac event | Posted | Number | 95% Confidence Interval | proportion of participants | 3 years |
|
|
| ||||||||||||||||||||||||||||||||||
| 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. | Per-protocol population of pooled adolescents and children who underwent coronary angiography | Posted | Number | 95% Confidence Interval | proportion | 6 months |
|
| |||||||||||||||||||||||||||||||||||
| 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. | All subjects who had undergone stress cardiac MPI studies | Posted | Number | participants | 3 years |
|
| ||||||||||||||||||||||||||||||||||||
| 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. | Posted | Number | 95% Confidence Interval | proportion | 24 hours |
|
| ||||||||||||||||||||||||||||||||||||
| 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. | Efficacy Evaluable Population | Posted | Count of Participants | Participants | 6 months |
|
|
AEs within 24+- 12 hours. SAEs up to 14 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Children (Ages 4-11) | Arm A children 4-11 years of age | 1 | 329 | 8 | 329 | ||
| EG001 | Adolescents (Ages 12-16) | Arm B adolescents 12-16 years of age | 0 | 116 | 5 | 116 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Overdose | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment | 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). |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
Limited number of subjects receiving coronary angiography limit the clinical implications of this endpoint comparing MPI and coronary angiography in children and adolescents.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cesare Orlandi, MD, Chief Medical Officer | Lantheus Medical Imaging | 978-671-8686 | Cesare.Orlandi@lantheus.com |
| ID | Term |
|---|---|
| D009080 | Mucocutaneous Lymph Node Syndrome |
| ID | Term |
|---|---|
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017256 | Technetium Tc 99m Sestamibi |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D015609 | Organotechnetium Compounds |
| D009942 | Organometallic Compounds |
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| >=65 years |
|
| Male |
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| Philippines |
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| Taiwan |
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| Canada |
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| Brazil |
|
| Thailand |
|
| Korea, Republic of |
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| Singapore |
|
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| Participants |
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| Participants |
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