Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00162032
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2005-09-09
Brief Title:
A Study to Evaluate the Use and Safety of CARDIOLITE in Pediatric Patients With Kawasaki Disease
Sponsor:
Lantheus Medical Imaging
Organization:
Lantheus Medical Imaging
Study Overview
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 Kawasaki Disease
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None