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

NCT00162032 | Completed Phase 3 Results

• 1 other identifier: CARDIOLITE® 301
• Study Type: interventional
• Target: 445
• Locations: 7 countries
• Sites: 50

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.

Conditions

Kawasaki Disease

Outcome Measures

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.

  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.

  3 years

Secondary Outcomes (4)

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

  6 months

• Incidence of Hard Cardiac Events

  3 years

• 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

  24 hours

• Predictive Value of Cardiolite For Cardiac Events

  6 months

Study Arms (2)

Children (Ages 4-11)

OTHER

Children 4-11 years of age, intervention Sestamibi

Drug: Sestamibi

Adolescents (Ages 12-16)

OTHER

Adolescents 12-16 years of age, intervention Sestamibi

Drug: Sestamibi

Interventions

Sestamibi DRUG

Sestamibi

Also known as: Cardiolite

Adolescents (Ages 12-16); Children (Ages 4-11)

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Terminal illness where expected survival is \< 6 months

Sponsors & Collaborators

• Lantheus Medical Imaging: lead

Study Sites (50)

Local Institution

Anchorage, Alaska, 99508, United States

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Little Rock, Arkansas, 72202, United States

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Los Angeles, California, 90027, United States

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Orange, California, 92868, United States

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San Diego, California, 92123, United States

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Denver, Colorado, 80218, United States

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Hartford, Connecticut, 06106, United States

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New Haven, Connecticut, 06511, United States

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Honolulu, Hawaii, 96813, United States

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Chicago, Illinois, 60614, United States

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Chicago, Illinois, 60637, United States

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Park Ridge, Illinois, 60068, United States

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Indianapolis, Indiana, 46201, United States

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Lexington, Kentucky, 40536, United States

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Boston, Massachusetts, 02111, United States

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Las Vegas, Nevada, 89109, United States

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New Hyde Park, New York, 11040, United States

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New York, New York, 10032, United States

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Durham, North Carolina, 27710, United States

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Greenville, North Carolina, 27858, United States

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Cincinnati, Ohio, 45229, United States

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Cleveland, Ohio, 44101, United States

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Hershey, Pennsylvania, 17033, United States

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Philadelphia, Pennsylvania, 19107, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Charlottesville, Virginia, 22906, United States

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Seattle, Washington, 98105, United States

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Spokane, Washington, 99204, United States

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Milwaukee, Wisconsin, 53203, United States

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Belo Horizonte, Brazil

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Campinas, Brazil

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Curitiba, Brazil

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Rio de Janeiro, Brazil

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São Paulo, Brazil

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Vancouver, British Columbia, Canada

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Halifax, Nova Scotia, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Quezon City, Philippines

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Daejeon, South Korea

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Pusan, South Korea

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Seoul, South Korea

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Suwon, South Korea

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Wŏnju, South Korea

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Changhua, Taiwan

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Taipei, Taiwan

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Bangkok, Thailand

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Hat Yai, Thailand

Location

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Interventions

Technetium Tc 99m Sestamibi

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Organotechnetium Compounds; Organometallic Compounds

Limitations and Caveats

Limited number of subjects receiving coronary angiography limit the clinical implications of this endpoint comparing MPI and coronary angiography in children and adolescents.

Results Point of Contact

• Title: Cesare Orlandi, MD, Chief Medical Officer
• Organization: Lantheus Medical Imaging

Cesare.Orlandi@lantheus.com

978-671-8686

Study Officials

• Qi Zhu, MD,

  Lantheus Medical Imaging

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 13, 2005
• Study Start: August 1, 2005
• Primary Completion: May 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 23, 2019
• Results First Posted: December 6, 2013

Record last verified: 2019-07

Locations

PH (1); BR (5); KR (5); TW (4); TH (2); CA (4); US (29)