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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 445
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Terminal illness where expected survival is < 6 months
研究组 & 干预措施
Children (Ages 4-11)
Children 4-11 years of age, intervention Sestamibi
干预措施: Sestamibi (Drug)
Adolescents (Ages 12-16)
Adolescents 12-16 years of age, intervention Sestamibi
干预措施: Sestamibi (Drug)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in Adolescents and Children Versus Coronary Angiography(6 months)
- Predictive Value of Cardiolite For Cardiac Events(6 months)
- Incidence of Hard Cardiac Events(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(24 hours)