Kawasaki Disease Clinical Trial
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
| Verified date | July 2019 |
| Source | Lantheus Medical Imaging |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 445 |
| Est. completion date | December 2010 |
| Est. primary completion date | May 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 4 Years to 16 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Local Institution | Belo Horizonte | |
| Brazil | Local Institution | Campinas | |
| Brazil | Local Institution | Curitiba | |
| Brazil | Local Institution | Rio de Janeiro | |
| Brazil | Local Institution | Sao Paulo | |
| Canada | Local Institution | Halifax | Nova Scotia |
| Canada | Local Institution | Montreal | Quebec |
| Canada | Local Institution | Toronto | Ontario |
| Canada | Local Institution | Vancouver | British Columbia |
| Korea, Republic of | Local Institution | Daejeon | |
| Korea, Republic of | Local Institution | Pusan | |
| Korea, Republic of | Local Insitution | Seoul | |
| Korea, Republic of | Local Institution | Suwon | |
| Korea, Republic of | Local Institution | Wonju | |
| Philippines | Local Institution | Quezon City | |
| Taiwan | Local Institution | Changhua | |
| Taiwan | Local Institution | Kaohsiung | |
| Taiwan | Local Institution | Taichung | |
| Taiwan | Local Institution | Taipei | |
| Thailand | Local Institution | Bangkok | |
| Thailand | Local Institution | Hat Yai | |
| United States | Local Institution | Anchorage | Alaska |
| United States | Local Institution | Boston | Massachusetts |
| United States | Local Institution | Charlottesville | Virginia |
| United States | Local Institution | Chicago | Illinois |
| United States | Local Institution | Chicago | Illinois |
| United States | Local Institution | Cincinnati | Ohio |
| United States | Local Institution | Cleveland | Ohio |
| United States | Local Institution | Denver | Colorado |
| United States | Local Institution | Durham | North Carolina |
| United States | Local Institution | Greenville | North Carolina |
| United States | Local Institution | Hartford | Connecticut |
| United States | Local Institution | Hershey | Pennsylvania |
| United States | Local Institution | Honolulu | Hawaii |
| United States | Local Institution | Indianapolis | Indiana |
| United States | Local Institution | Las Vegas | Nevada |
| United States | Local Institution | Lexington | Kentucky |
| United States | Local Institution | Little Rock | Arkansas |
| United States | Local Institution | Los Angeles | California |
| United States | Local Institution | Milwaukee | Wisconsin |
| United States | Local Institution | New Haven | Connecticut |
| United States | Local Institution | New Hyde Park | New York |
| United States | Local Institution | New York | New York |
| United States | Local Institution | Orange | California |
| United States | Local Institution | Park Ridge | Illinois |
| United States | Local Institution | Philadelphia | Pennsylvania |
| United States | Local Institution | Pittsburgh | Pennsylvania |
| United States | Local Institution | San Diego | California |
| United States | Local Institution | Seattle | Washington |
| United States | Local Institution | Spokane | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Lantheus Medical Imaging |
United States, Brazil, Canada, Korea, Republic of, Philippines, Taiwan, Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Estimate the Performance of Cardiolite® Rest and Stress MPI for the Detection of Myocardial Ischemia in Adolescents and Children Versus Coronary Angiography | 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. | 6 months | |
| Secondary | Incidence of Hard Cardiac Events | Examine the incidence of hard cardiac events (myocardial infarction [MI] or cardiac death) in KD subjects with positive and negative MPI scans. | 3 years | |
| Secondary | 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 | 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. | 24 hours | |
| Secondary | Predictive Value of Cardiolite For Cardiac Events | Determine the incidence of cardiac events occurring over a 6 month follow up period in pediatric subjects with normal myocardial perfusion scans. | 6 months |
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