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

Lantheus Medical Imaging logo

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)

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

Trial contacts and locations

50

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Data sourced from clinicaltrials.gov

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