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Completed

NCT Number: NCT00162032

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

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.

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Key information

Conditions

Kawasaki Disease Cardiovascular Diseases Hemic and Lymphatic Diseases Lymphatic Diseases Mucocutaneous Lymph Node Syndrome Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Belo Horizonte, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sestamibi

Drug

Sestamibi

Other names: Cardiolite

Primary outcomes

  1. Determine the Predictive Value of Cardiolite® Rest and Stress MPI to Define Pediatric Populations With Kawasaki Disease at High and Low Risk of Developing Cardiac Events.

    Time frame: 3 years

    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 outcomes

  1. Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in Adolescents and Children Versus Coronary Angiography

    Time frame: 6 months

    Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of myocardial perfusion imaging (MPI) for the diagnosis of ischemic heart disease (IHD) relative to coronary angiography. Coronary stenoses of ≥ 50% were classified as disease. SSS > 4 in MPI was classified as positive for IHD.

  2. Incidence of Hard Cardiac Events

    Time frame: 3 years

    Examine the incidence of hard cardiac events (myocardial infarction [MI] or cardiac death) in KD subjects with positive and negative MPI scans.

  3. Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in the Left Anterior Descending (LAD) Artery in Adolescents and Children Versus Coronary Angiography

    Time frame: 24 hours

    Sensitivity, specificity, PPV, and NPV of SDS for myocardial perfusion corresponding to the left anterior descending (LAD) for the diagnosis of IHD in the distribution of the left anterior descending (LAD) artery relative to coronary angiography based diagnosis were determined. Coronary stenoses of ≥ 50% for arteries associated with LAD territories were classified as LAD disease. SDS LAD > 1 was classified as positive for IHD for the LAD distribution.

  4. Predictive Value of Cardiolite For Cardiac Events

    Time frame: 6 months

    Determine the incidence of cardiac events occurring over a 6 month follow up period in pediatric subjects with normal myocardial perfusion scans.

Sponsors and collaborators

Lead sponsor

Lantheus Medical Imaging

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Sep 13, 2005
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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