A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT00162032
First received: September 9, 2005
Last updated: October 8, 2013
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Kawasaki Disease
Drug: Sestamibi
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Lantheus Medical Imaging:

Primary Outcome Measures:
  • Kawasaki Disease Population at High and Low Risk of Developing Cardiac Events Though Three Years Follow-up. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 445
Study Start Date: August 2005
Study Completion Date: December 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Children (Ages 4-11)
Children 4-11 years of age, intervention Sestamibi
Drug: Sestamibi
Sestamibi
Other Name: Cardiolite
Adolescents (Ages 12-16)
Adolescents 12-16 years of age, intervention Sestamibi
Drug: Sestamibi
Sestamibi
Other Name: Cardiolite

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.

  Eligibility

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 maximum heart rate

Exclusion Criteria:

  • Terminal illness where expected survival is < 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162032

  Show 50 Study Locations
Sponsors and Collaborators
Lantheus Medical Imaging
Investigators
Study Director: Qi Zhu, MD, Lantheus Medical Imaging
  More Information

No publications provided

Responsible Party: Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT00162032     History of Changes
Other Study ID Numbers: CARDIOLITE® 301
Study First Received: September 9, 2005
Results First Received: April 30, 2013
Last Updated: October 8, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mucocutaneous Lymph Node Syndrome
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
Technetium Tc 99m Sestamibi
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 15, 2014