Clinical Trial: A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 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.
Original Primary Outcome: The predictive value of test results obtained from Sestamibi myocardial perfusion imaging will be evaluated to define a Kawasaki Disease population at high and low risk of developing cardiac events though 10 years follow-up.
Current Secondary Outcome:
- Concordance Will be Determined Between the Presence of Perfusion Abnormalities Detected on Sestamibi Images and the Classification of Ischemic Heart Disease. [ Time Frame: 3 year follow up ]
- In Addition, a Determination of the Safety of Sestamibi Will be Evaluated at the End of the Study Through Adverse and Serious Adverse Events Reported and Evaluating Vital Signs, ECGs, Physical Exams and Laboratory Tests for Each Subject. [ Time Frame: 3 year follow up ]
Original Secondary Outcome:
- Concordance Will be Determined Between the Presence of Perfusion Abnormalities Detected on Sestamibi Images and the Classification of Ischemic Heart Disease.
- In Addition, a Determination of the Safety of Sestamibi Will be Evaluated at the End of the Study Through Adverse and Serious Adverse Events Reported and Evaluating Vital Signs, ECGs, Physical Exams and Laboratory Tests for Each Subject.
Information By: Lantheus Medical Imaging
Dates:
Date Received: September 9, 2005
Date Started: August 2005
Date Completion:
Last Updated: October 8, 2013
Last Verified: April 2012
