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

Lantheus Medical Imaging

Status and phase: Completed; Phase 3

Conditions: Kawasaki Disease

Treatments: Drug: Sestamibi

Study type: Interventional

Funder types: Industry

Identifiers

NCT00162032

CARDIOLITE® 301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 445 patients

Sex: All

Ages: 4 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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445 participants in 2 patient groups

Children (Ages 4-11)

Other group

Description:

Children 4-11 years of age, intervention Sestamibi

Treatment:

Drug: Sestamibi

Adolescents (Ages 12-16)

Other group

Description:

Adolescents 12-16 years of age, intervention Sestamibi

Treatment:

Drug: Sestamibi