Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00162032 | A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease | PHASE3 | COMPLETED | 445 | — | — | Aug 1, 2005 | Dec 1, 2010 | Jul 23, 2019 | 50 | United States, Brazil +5 |
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| Sestamibi | DRUG | Sestamibi |
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 maxim...