Kawasaki MATCH: A Clinical Decision Support Tool to Detect KD
Phase: NA
Conditions: Kawasaki Disease
Sponsor: University of California, San Diego

 
 
 
 
 
 
 
Study Protocol 
 
 
Title: “Kawasaki MATCH: A Clinical Decision 
Support Tool to Detect KD” 
 
 
Parent Study: “Gene Expression in Kawasaki Disease 
and other inflammatory conditions” 
 
 
 
Version date August 19, 2025

 
 
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UCSD Human Research Protections Program 
New Biomedical Application 
RESEARCH PLAN 
Instructions for completing the Research Plan are available on the HRPP website. 
The headings on this set of instructions correspond to the headings of the Research Plan. 
General Instructions: Enter a response for all topic headings.  
Enter “Not Applicable” rather than leaving an item blank if the item does not apply to this project. Version date: 9/30/2013 
RP Rev 19AUG2025 
1. 
PROJECT TITLE 
 Study #140220:  Gene Expression in Kawasaki Disease and other inflammatory conditions 
2. 
PRINCIPAL INVESTIGATOR  
Jane C. Burns, M.D. 
3. 
FACILITIES 
Rady Children's Hospital - San Diego 
4. 
ESTIMATED DURATION OF THE STUDY 
7 Years 
5. 
LAY LANGUAGE SUMMARY OR SYNOPSIS (no more than one paragraph) 
Kawasaki disease (KD) is an illness characterized by inflammation of blood vessels that supply the heart 
muscle (coronary arteries).  There are other inflammatory conditions that also affect the heart in children. 
Multisystem inflammatory syndrome of children (MIS-C), which is a condition related to exposure to the 
SARS-CoV-2 coronavirus, is one of them. While the immediate effects of Kawasaki disease may not be 
serious, in some cases, there is permanent damage to the coronary arteries and heart muscle.  Kawasaki disease 
affects children almost exclusively.  Most patients are under 5 years of age and all races and ethnicities can be 
affected. Children with MIS-C tend to be older. This study will focus on identifying the proteins and molecular 
pathways that play a role in the disease process of KD and MIS-C with the goal of developing a diagnostic test 
for the disease, improving treatments, and finding the cause for the disease. 
 
6. 
SPECIFIC AIMS 
Hypotheses: 
1) Identification of the gene expression pattern in whole blood and peripheral blood mononuclear cells 
(PBMC) during acute KD and MIS-C will contribute to our understanding of the pathogenesis of this 
disease. 
2) Understanding the immune response will elucidate the mechanism of action of intravenous 
immunoglobulin (IVIG) and may inform us as to the nature of the trigger for KD 
3) The characteristic pattern of gene expression in whole blood and PBMC and protein levels in serum, 
plasma, and urine from patients with acute KD and MIS-C will distinguish them from patients with 
similar-appearing non-KD illnesses. This distinction will allow us to develop a diagnostic test even if 
we remain ignorant as to the causative agent. 
Aims: 
1) To characterize the pattern of gene expression and protein biomarkers in blood from KD and MIS-C 
patients at different stages of disease. 
2) To identify a unique pattern of RNA or protein(s) associated with acute KD and MIS-C by comparing the 
patterns during acute KD with patterns present in patients with known infectious and allergic 
conditions that appear similar to KD. 
3) To develop a diagnostic test for KD and develop a natural language processing (NLP) tool to identify KD 
patients in the EMR 
4) To understand the immune response in KD and MIS-C patients and the mechanism of action of IVIG 
5) To evaluate adverse events related to treatment for KD and MIS-C.  

 
 
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6) To bank body fluids for future studies. 
7) To determine the frequency of gallbladder hydrops in acute KD patients. 
8) To record sociodemographic data and parent/guardian observations of signs/symptoms prior to admission 
to the hospital. 
9) To evaluate the accuracy of a clinical decision support tool (previously known as KIDMATCH, now 
known as Kawasaki Match). 
7. 
BACKGROUND AND SIGNIFICANCE 
Kawasaki disease (KD) is an acute vasculitis of infancy and early childhood that has now replaced rheumatic 
fever as the leading cause of acquired heart disease in children in the United States and Japan (Taubert et al., 
1991; Kawasaki et al., 1974). Although the acute illness resolves spontaneously, permanent damage to the 
coronary arteries occurs in 20-25% of untreated children. The cause of KD remains unknown and there is no 
specific laboratory test to identify affected children (Burns 2005).  Nonetheless, high dose intravenous 
immunoglobulin (IVIG) administered within the first 10 days of fever significantly reduces the risk of coronary 
artery damage by unknown mechanisms (Newburger et al., 1991). KD thus presents a unique dilemma: the 
disease may be difficult to recognize, there is no diagnostic laboratory test, there is an extremely effective 
therapy, and there is a 25% chance of serious cardiovascular damage or death if the therapy is not administered. 
     Beginning in mid-March 2020, pediatricians in communities in Western Europe, the UK, and the Eastern 
U.S. that had been severely affected by the Covid-19 pandemic noted an increased number of children 
presenting with fever and evidence of severe inflammation who required admission to intensive care. A 
hallmark of these cases was heart failure leading to shock and the absence of significant pulmonary disease. In 
the US, the CDC named the condition Multisystem Inflammatory Syndrome in Children (MIS-C). The clinical 
presentation in these patients shared many features with KD. The inflammatory markers, however, were much 
higher even than KD shock syndrome, a variant of KD presenting with distributive shock and requiring 
inotropic and vasoactive support in the ICU. Some patients were polymerase chain reaction (PCR)+ for SARS-
CoV-2 while most were virus-negative, but many had detectable antibody suggesting that MIS-C was an 
immune-mediated reaction to antecedent exposure to the virus. Curiously, while patients were being diagnosed 
with MIS-C, the numbers of children meeting clinical criteria for KD but with unusual features increased 
dramatically in these same regions. Data from the UK suggested that there was a lag of several weeks from the 
peak of Covid-19 in the adult population before children with MIS-C began to appear. Patients have responded 
to treatment with intravenous immunoglobulin (IVIG) sometimes with additional anti-inflammatory therapy 
and some have developed coronary artery aneurysms. 
This proposal brings together an interdisciplinary team from academic centers throughout the U.S. and abroad 
to characterize transcript patterns, levels of candidate proteins, microbiome data from swabs, and PBMC and 
neutrophil populations in acute and convalescent KD and MIS-C patients and in children with other fever/rash 
illnesses. Biomarkers will be sought that distinguish KD and MIS-C from febrile controls. Healthy controls are 
also needed as many of these proteins have not been previously measured in children. In collaboration with 
Alessandra Franco at UCSD and other universities in the U.S. and abroad, the immune response and 
mechanism of action of IVIG will be characterized. In collaboration with climate scientists at UCSD, SIO, and 
other academic centers, we will analyze the distribution and timing of KD cases in our community through GPS 
mapping of patient’s primary residence. 
 
 
8. 
PROGRESS REPORT 
We have now collected RNA, plasma, serum, and urine samples from 2612 patients which includes KD, MIS-
C, and control subjects. A password-protected, web-based data entry system in REDCap now houses all data 
from the KD, MIS-C, and control subjects enrolled to date. This allows access of all investigators at UCSD and 
collaborating sites to de-identified individual patient data via the unique study number. Critical advances from 

 
 
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this research protocol to date include the following: 
1) Elucidation of gene expression patterns in whole blood from KD patients over time 
2) Identification of biomarker candidates for diagnosis 
3) Creation of a diagnostic algorithm to aid clinicians in identifying KD patients (patent issued) 
4) Elucidation of the critical role of dendritic cell and T cell regulation in downregulating inflammation in 
KD patients 
5) Elucidation of the mechanisms of action of IVIG in KD patients 
6) Epidemiologic studies suggesting clustering of KD cases in time and space 
 
9. 
RESEARCH DESIGN AND METHODS 
• 
Laboratory procedures and data collection: 
• 
12.5 cc of blood (2.5 teaspoons) (for RNA studies, plasma protein studies, serum antibody 
measurement, and in vitro studies of PBMC and cultured human umbilical vein endothelial cells 
(HUVECs)) will be drawn when phlebotomy is performed for routine clinical care from control and KD 
and MIS-C patients. For KD and MIS-C patients, this is usually at the time of admission, 24-48h after 
treatment and before discharge, at the 2- and 6-week clinic visits, and at one year. For healthy control 
patients undergoing orthopedic surgery, blood samples will be obtained at the time that an IV is started 
in the OR. Samples will be obtained before administration of IVIG for KD and MIS-C patients and 
serially thereafter when phlebotomy is necessary for routine clinical care. RNA will be extracted from 
whole blood and the plasma and serum frozen at -70°C. No further phlebotomy will be performed on 
control subjects. PBMCs and neutrophils will be studied in the Burns, Franco, and Croker Labs at 
UCSD. 
 
• 
New information about diastolic dysfunction late after KD has spurred our interest in pursuing protein 
biomarkers that may signal cardiomyocyte damage in a subset of these patients. Blood samples from 
convalescent KD patients will be used for cardiac biomarker studies in collaboration outside companies 
who have specific assays for candidate biomarkers. Oxitope, Illumina, Anabios and OP2 are among the 
many companies with whom we are collaborating.  Plasma and serum samples will be shared with 
Oxitope for the measurement of oxidized phospholipids using their in-house assay.  RNA and plasma 
samples will be shared with Illumina.  
 
Additional collaborations:  
▪ Plasma and serum samples from febrile control subjects, Kawasaki disease subjects, and MIS-C 
subjects will be shared with Juan Salazar, M.D., M.P.H. at the University of Connecticut.  
Material will be further distributed to Dr. Lynes at the University of Connecticut and Dr. 
Lawrence at Albany for this collaboration.   
▪ RNA and plasma samples will be shared with Charles Chiu, MD, PhD at UCSF.   
▪ 
Plasma samples from febrile control subjects, Kawasaki disease subjects, and MIS-C subjects 
will be sent to Iwijn De Vlaminck at Cornell for cell-free DNA and RNA analysis.  
▪ Dr. Mohit Jain at Sapient Bioanalytics, San Diego, who will perform metabolomics assays using 
Next Gen mass spectrometry on banked plasma samples at UCSD that were from KD patients 
and febrile controls at RCHSD. 
▪ Plasma and serum samples from febrile control subjects, Kawasaki disease subjects, and MIS-C 
subjects will be shared with Baylor College of Medicine.  
▪ Plasma and serum samples from febrile control subjects, Kawasaki disease subjects, and MIS-C 
subjects will be shared with SomaLogic who will perform proteomics. These data will then be 
shared with University of Pennsylvania.  
 
MTAs will be established for all send-outs as appropriate. A Moore clause has always been included in 

 
 
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the consent to cover the collaborations with commercial entities.  
 
• 
KD and MIS-C patients only will have 1 cc of IVIG withheld in the RCHSD Pharmacy for testing 
glycosylation patterns of the IgG and other in vitro experiments. This sample will only be obtained from 
patients for whom the calculated dose (volume of a 10% solution) is less than the total amount prepared, 
which would otherwise be discarded. 
 
• 
All patients: Throat or NP swabs will be sent to the Burns laboratory for microbiome studies. 
 
• 
All patients: Urine for biochemical and molecular studies will be collected in a bag (infants) or in a cup 
for older children. If spontaneously voided urine is not available, we will not pursue urine collection 
further. Urine will be sent to the Burns laboratory for processing for biochemical and molecular studies. 
 
• 
All patients: Any leftover patient samples obtained for routine care such as blood, urine, synovial fluid,    
            or CSF. 
 
FC and KD patients will be offered an ultrasound of the right upper quadrant to examine the gallbladder. This 
procedure will add approximately 5 minutes to the ED visit. Subjects may agree to the phlebotomy portion of 
the study but decline the ultrasound. Gallbladder hydrops is associated with the acute phase of KD and may be 
associated with an increase in ALT and GGT in the plasma and bilirubin in the urine.  The incidence of 
gallbladder hydrops in KD has never been systematically assessed in a prospective study. The ultrasound 
examinations will be performed by ED physicians who are certified to perform ultrasound in the ED setting. 
The findings from the ultrasound will not be included in the medical record from the ED visit. This 
examination is considered research and will not generate any charges to the patient/family. Incidental findings 
will not be reported. Six attendings are certified for this ultrasound testing. Thus, patients will only be studied 
when these attendings are working in the ED. When available, a team member credentialed in biliary 
ultrasonography will obtain limited video and still images of the right upper quadrant in order to characterize 
biliary anatomy (presence of gallstones, sludge, pericholecystic fluid) and to measure gallbladder dimensions, 
wall thickness and diameter of the common bile duct. We will perform descriptive statistics of biliary features 
and measurements and will compare subjects with KD and febrile controls with regard to frequency of 
abnormal anatomic features and linear measurements of gallbladder and common bile duct. 
 
• 
All patients:  
▪ Demographic and physical examination data: Patient's date of birth, sex, self-reported ethnicity 
of each parent, date of disease onset (first day of fever), date of study entry, and street address 
and zip code of primary residence will be recorded for GPS mapping (KD patients only). 
Physical findings typically associated with KD and specifically not associated with KD will be 
recorded (Burns et al., 1991). We will also record previous treatment received by patient (e.g. 
antibiotics). 
 
▪ Laboratory data: Laboratory data obtained as part of routine patient care will be recorded as 
available. All data from echocardiograms will also be entered. This information will be used to 
help categorize patients into disease groups and will include microbiology, virology, 
hematology, and clinical chemistry data. Culture and PCR results will be recorded.  
 
• 
All patient data will be housed in a password-protected REDCap database with two-factor 
authentication required for access. All biologic samples will be stored in the KD Research Center 
Biobank housed on the UCSD campus, Biomedical Science Building, 2nd fl. 
 
• 
Data analysis for diagnostic test development: This sub-study will use existing de-identified data and 
samples to test the performance of a diagnostic algorithm for KD that includes clinical and laboratory 

 
 
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data and new biomarkers for KD diagnosis. These de-identified data will be shared with colleagues at 
UCSD, USC, and Stanford University who are performing statistical analysis. 
 
• 
Data analysis for cardiovascular outcomes: De-identified patient data will be shared with IKDR Data 
Coordinating Centre (Hospital for Sick Children in Toronto) and IKDR Data Analytics Centre (Johns 
Hopkins University) for the International Kawasaki Disease Registry (IKDR) studies “IKDR – KD and 
COVID” and sub-study entitled “A data science approach to identify and manage Multisystem 
Inflammatory Syndrome in Children (MIS-C) associated with SARS-CoV-2 infection and Kawasaki 
disease in pediatric patients (NIH PreVAIL kIds program)” respectively where collaborators are 
performing an analysis of risk factors for coronary artery aneurysm formation and outcomes. No PHI 
will be shared. A DTA will cover the sharing of this information. The consent form already covers the 
sharing of data with collaborators. 
 
• 
Data analysis for adverse events related to treatment for Kawasaki disease and MIS-C.  We will utilize 
Clarity Reports built by Health Information Services to assist us with identifying side effects, conditions 
or events that may be related to the various treatment regimens for Kawasaki disease and MIS-C.  
 
• 
Data analysis for developing a Natural Language Processing (NLP) tool: This sub-study will use 
existing data in the form of ED notes to develop an NLP tool that will distinguish KD patients from 
febrile controls. The NLP team at UCSD will use machine learning techniques to teach the computer to 
read ED and Urgent Care notes from children already enrolled in the study with signed informed 
consent for blood drawing. These notes will be anonymized and used for training the testing the NLP 
tool. Use of these data is already covered in the HIPAA authorization and the signed consent form so no 
amendments are necessary. 
 
• 
Data analysis in partnership with our Machine Learning/AI team has created a physician support tool 
(Kawasaki Match – previously known as KIDMATCH). This tool is implemented into the RCHSD 
system and is currently being used for routine clinical care of subjects with febrile illnesses and 
suspicion for KD. Patient data (physical findings and laboratory data) will be entered into Kawasaki 
Match. Kawasaki Match will develop a risk score for KD. Treating study providers may or may not be 
offered the results of this algorithm. All data elements to be included are obtained as other parts of this 
study, no additional data will be obtained to run Kawasaki Match. Algorithm results will be provided 
only to members of the RCHSD Emergency Department Study Team (see 21 below). Providers will be 
queried regarding their confidence in diagnosis as well as usefulness of the algorithm on a visual 
analogue scale. 
 
• 
Data analysis of Transition of Care survey: KD patients who are at least 12 years old and have a history 
of coronary artery aneurysms will receive a Transition of Care survey to assess their health literacy. 
This will be administered annually and their performance over time will be assessed. De-identified data 
will be analyzed.  
 
• 
Proteomics will be performed on samples at SomaLogic. The data will be distributed to Dr. Burns’ KD 
lab team as well as University of Pennsylvania, who will collaborate on data analysis.  
 
10. 
HUMAN SUBJECTS 
We plan to enroll 4,500 subjects in this study (includes KD patients, MIS-C, and controls) to allow for the 
collection of data and samples from cohorts that will support the many different aims in this study. We need to 
enroll healthy control children as the normal levels of many of these protein biomarkers have not been 

 
 
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determined in a pediatric population. 
 
Inclusion criteria: 
 
Four patient populations will be recruited for this study: patients with KD, patients with MIS-C.  
patients with infectious or allergic diseases that appear similar to KD (febrile control group), and otherwise 
healthy infants and children who are Orthopedic Surgery patients with no underlying disease or children who 
are having blood obtained for mandated lead screening. 
 
               Children from 1 month through 17 years of age will be recruited for all study groups (KD and MIS-C 
patients and control patients). Inclusion criteria for KD patients will be fever plus 4/5 standard clinical criteria 
(Kawasaki et al., 1974). On a case-by-case basis, KD patients who do not meet full criteria but who have 
supportive laboratory and echocardiographic data may also be enrolled at the PI's discretion. MIS-C patients 
may be SAR-CoV-2 antibody positive or negative.  Patients must have blood samples drawn before IVIG 
administration. 
 
 
Febrile control patients with diseases that appear similar to KD will be recruited from the Emergency 
Dept. (ED) at RCHSD. Eligible patients must have fever and one or more of the following clinical features: a) 
rash, b) conjunctival injection, c) red lips or oropharynx, d) swollen hands or feet. Infants <1 yr. with at least 7 
days of fever and no obvious source of the fever will be enrolled even in the absence of physician signs 
suggestive of KD. All control patients must require phlebotomy as part of their clinical evaluation. 
 
            Healthy control children will be enrolled at the time of surgery. A partial waiver of HIPAA consent is 
requested to obtain weekly schedule from the Orthopedic Surgery Office for patients who may be suitable for 
the study. Signed informed consent will be obtained from the parents by members of the research team, under 
the supervision of our KD nurse coordinator, Joan Pancheri. An alternative source of healthy controls are 
children having blood drawn for routine lead screening at RCHSD outpatient laboratory and children 
undergoing dental surgery at RCHSD. 
 
Exclusion criteria: 
 
All patients with pre-existing major medical conditions will be excluded. This includes patients with 
known genetic disorders (e.g., trisomy 21, cystic fibrosis), conditions requiring continuous medication (e.g. 
seizure disorder, asthma, heart disease), or known immune disorder (e.g. hypogammaglobulinemia, 
complement deficiency). Patients who have received oral steroids in the previous week will be excluded. For 
the healthy control cohort, patients who have serious underlying medical conditions will be excluded. 
 
11. 
RECRUITMENT AND PROCEDURES PREPARATORY TO RESEARCH 
Subjects will be recruited from the ED, inpatient units at RCHSD, and Orthopedic Surgery.  For the Orthopedic 
Surgery control subjects, weekly logs for the OR will be reviewed to identify suitable candidate subjects. For 
Orthopedic subjects, the parents of the subject will be approached on the day of the surgery and offered 
participation. For the healthy controls who will be having routine lead screening, patients will be enrolled 
through the pediatrician’s office in the MOB at the time of their well-child check by study personnel. Families 
with KD or MIS-C will be recruited by ED co-investigators when the child is admitted to RCHSD for 
evaluation and treatment or by Dr. Burns or Dr. Tremoulet in the case of direct admission that bypasses the ED. 
 
12. 
INFORMED CONSENT 
Study participation will be offered without regard to age, sex, or ethnic background. Child assent will be 
obtained for all study patients ≥ 7 yrs. and adolescent assent will be obtained for patients ≥ 12 yrs.  presenting 
with features of either KD or MIS-C. An adult consent has been added for enrollment of young adults. 
Recruitment of human subjects with Informed Consent will be obtained by study personnel in the ED, the 

 
 
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hospital inpatient units, and the Orthopedic Surgery area. On occasion in the ED, no study personnel are 
available in which case one of the co-investigators (Drs. Burns or Tremoulet) is contacted by telephone.  The 
Parent (child/ adolescent if applicable) is provided with the written consent form and HIPAA authorization by 
ED personnel and the co-investigator reviews the written informed consent document(s) over the phone and 
answers any questions.  The parent (child/adolescent if applicable) then signs and dates the consent 
document(s) and the witness signature is obtained at a later date from the co-investigator who obtained the 
informed consent.   
 
Consent will be obtained electronically (via RCHSD’s RedCap) using an iPad, or on paper if an iPad is not 
available in the ED, and on paper only on the wards and in clinic. Electronic consents will be stored in Epic. 
Paper consents will be stored in a filing cabinet in a locked room that is only accessible to designated research 
staff at RCHSD. 
 
A partial waiver of HIPAA authorization is requested to allow screening of suitable subjects to approach for 
enrollment as healthy controls.  HIPAA authorization is obtained. All patient information is kept in a secure, 
password-protected computer file in Dr. Burns’ office.  
 
13. 
ALTERNATIVES TO STUDY PARTICIPATION 
Alternative is to decline participation. This is not an intervention study. 
 
14. 
POTENTIAL RISKS 
The risks are bruising and discomfort at the venipuncture site associated with phlebotomy, local discomfort 
associated with swabbing of the nasopharynx, throat, and rectum. In addition, there is the potential for loss of 
confidentiality. 
 
15. RISK MANAGEMENT PROCEDURES AND ADEQUACY OF RESOURCES 
Patient confidentiality will be protected by assignment of a unique study number to all data and samples. No 
publication or written reports will link patient data with a name. Entry into the computer data files will require a 
password. The patient’s full name will not be entered into the file but a log sheet with the study number and 
name will be kept in the PI’s office in a locked, password-protected computer file. The patient's full name is 
also logged into the RCHSD data base as required for all research subjects at RCHSD. Access to this database 
is password protected. 
 
16. PRIVACY AND CONFIDENTIALITY CONSIDERATIONS INCLUDING DATA ACCESS AND MANAGEMENT 
Only members of the study team will have access to study files and documents. The coded list linking subject’s 
names to their study number will be kept in a secure, password protected computer file as in Section 15. 
Participants will be afforded adequate privacy with the informed consent process, discussions with the study 
team, and with all study related visits and procedures.  Parents are encouraged to be present for all study visit / 
procedures and may remain with the child per hospital policy. Study subjects may meet privately with the study 
doctor if requested. 
 
17. POTENTIAL BENEFITS 
There will be no direct benefit to the subject from participation in this study. No results will be shared with the 
patients or referring physicians since this information will be generated in the Burns Laboratory, which is a 
research laboratory, not a CLIA-certified laboratory. 
18. RISK/BENEFIT RATIO 

 
 
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This project is categorized as a "minimal risk/no direct benefit" study: 45 CFR 46.404. The potential benefit to 
society with the generation of new information about KD and MIS-C and the potential to design a diagnostic 
test and identify children at risk for failing to respond to IVIG justify the minimal risks to the study subject and 
his/her family. 
 
19. EXPENSE TO PARTICIPANT 
None 
 
 
20. COMPENSATION FOR PARTICIPATION 
None 
 
 
21. PRIVILEGES/CERTIFICATIONS/LICENSES AND RESEARCH TEAM RESPONSIBILITIES 
All persons associated with this study have taken the CITI and HIPAA training. 
 
Dr. Jane C. Burns is the Principal Investigator for the study.  She is a UCSD faculty member in the Department of 
Pediatrics and a licensed physician in the State of California.  Dr. Burns has medical staff privileges at RCHSD. 
 
Burns Lab Team:  
 
1. Jennifer Kim is a UCSD employee and the data manager for the KD Research Center.  She will assist with 
data analysis and data entry. 
2. Dr. Alessandra Franco is an immunologist and UCSD faculty member in the Department of Pediatrics and 
will perform the immunology studies. She will not be involved with direct patient care. 
3. Dr. Chisato Shimizu is a Project Scientist at UCSD in the Burns Laboratory. 
4. Ms. Sophia Hernandez is a laboratory technician in the Burns Lab who logs in and processes specimens.  
5. Dr. Adriana Tremoulet is a Sub-investigator on the study. Dr. Tremoulet is a UCSD faculty member in the 
Department of Pediatrics and a licensed physician in the State of California.  She has medical staff 
privileges at RCHSD and will be involved with KD, MIS-C, and control patient enrollment, data 
collection, data review and data analysis. 
6. Ben Croker, PhD is a neutrophil researcher at UCSD who will be studying KD neutrophils.  
7. Jonathan Lam is a PhD candidate with the UCSD Department of Biomedical Informatics.  He will assist 
with data analysis.   
8. Ellen Xu is a UCSD student and a research assistant on the AI Project 
9. Alyssa Linkenheil, MD is a pediatric resident at UCSD and will assist with data analysis of the 
Transition of Care Study. 
10. Shoko Yamazaki, MD is a visiting physician from Japan and will assist with data collection and entry.  
11. Koichi Miyata, MD is a visiting physician from Japan and will assist with data analysis.  
12. Corinna Puyat, MD is a resident at RCHSD and will assist the Burns Lab team with projects. 
 
RCHSD Emergency Department Team:  
 
The following physicians and Nurse Practitioner are employees of RCHSD Emergency Department.  They are 
licensed in the State of California and will assist with the enrollment of subjects in the ED. 
 
1. Dr. Michael Gardiner is a Sub-investigator on the study. Dr. Gardiner is a UCSD faculty member in the 
Department of Pediatrics and a licensed physician in the State of California.  He has medical privileges at 
RCHSD and is an Emergency Department physician.  He will assist with study enrollment, data 
collection, data review and data analysis.  
2. Lukas Austin-Page, MD 
3. Joe Bartoletti, MD 

 
 
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4. Amy Bryl, MD  
5. Jennifer Case, MD 
6. Elizabeth Chang, MD 
7. Heather Conrad, MD 
8. Gemmie Devera, MD 
9. Joelle Donofrio Ödmann, DO 
10. Kyna Donohue, MD 
11. Atim Ekpenyong, MD 
12. David Gutglass, MD  
13. Scott Herskovitz, MD 
14. Paul Ishimine, MD 
15. Simon Lucio, MD 
16. Katherine Mandeville, MD 
17. Michelle McDaniel, MD 
18. Ashley Metcalf, MD 
19. David Mills, MD  
20. Margaret Nguyen, MD 
21. Mylinh Nguyen, MD 
22. Kathryn Pade, MD  
23. Brian Park, MD 
24. Dunisha Ranasuriya, MD 
25. Fareed Saleh, MD, MHA 
26. Stephanie Schroter  
27. Kristy Schwartz, MD 
28. Vanessa Tamas, MD 
29. Andrew Tang, DO 
30. Nicole Titze, MD 
31. Stacey Ulrich, MD 
32. Tatyana Vayngortin, MD 
33. Caroline Vega, MD  
34. Yvette Wang, MD 
35. Karen Yaphockun, DO 
36. Elise Zimmerman, MD 
 
Gallbladder ultrasound team: John Kanegaye, MD, Kathryn Pade, MD, Mylinh Nguyen, MD, Atim 
Ekpenyong, MD, Shahfar Khan, MD, and Nicole Barbera, DO, faculty members in the UCSD 
Department of Pediatrics, Division of Emergency Medicine and attending physicians in the Emergency 
Department at RCHSD, are credentialed in Emergency Ultrasonography and will participate in 
recruitment and enrollment of subjects, collection of clinical data, and acquisition of ultrasound images. 
 
Kathryn Hollenbach, PhD, MPH is a UCSD Research Associate in the Department of Pediatrics.  She will be 
working with the Emergency Department Research Associates to identify subjects for enrollment into the study. 
She will oversee notifying the IRB regarding all changes in personnel and CITI training. 
 
Rady Children’s Team  
   
1. Sherrie Bandy, MS, is a senior clinical research coordinator at RCHSD. Ms. Bandy will be the lead 
coordinator for the study and will assist with the enrollment of subjects, data collection, IRB submissions 
and the maintenance of regulatory and other research records for the study.    
2. Joan Pancheri, RN, BSN, CCRC, is a clinical research nurse coordinator and licensed RN in the State of 

 
 
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California. Ms. Pancheri is the back-up research coordinator for the study and will assist with the 
enrollment of subjects, data collection, IRB submissions and the maintenance of regulatory and other 
research records. 
3. Manaswitha Khare, MD is a hospitalist at RCHSD and a licensed physician in the State of California. Dr. 
Khare will assist with subject enrollment and specimen collection.  
4. Kirsten Dummer, MD, is a pediatric cardiologist in the Division of Cardiology in the Dept. of Pediatrics. 
Dr. Dummer will assist with echo and MRI interpretation for the KD and MIS-C patient populations. 
5. Alexis Quade, MD is a UCSD Resident in the Department of Pediatrics who will be assisting with data 
analysis.  
 
22. BIBLIOGRAPHY 
Burns JC, Mason WH, Glode MP, Shulman ST, Melish ME, Meisner C, Bastian J, Beiser AS, Meyerson HM, 
Newburger JW and the U.S. Multicenter Kawasaki Study Group.  Clinical and epidemiological characteristics 
of patients referred for evaluation of possible KD. J Pediatr. 118:680-686,1991. 
 
Burns JC and Glode MP. Kawasaki Syndrome. Seminar series. Lancet 2004;364: 533-543. 
Cummings CA and Relman DA. Using DNA microarrays to study host-microbe interactions. Emerg Infect Dis. 
2000;6:513-525. 
Kawasaki T, Kosaki F, Okawa S, et al. A new infantile acute febrile mucocutaneous lymph node syndrome 
(MCLS) prevailing in Japan. Pediatrics 1974;54:271-6. 
 
Newburger JW, Takahashi M, Beiser AS, et al. Single infusion of intravenous gamma globulin compared to 
four daily doses in the treatment of acute Kawasaki Syndrome. New Engl J Med. 1991; 324:1633-9. 
 
Popper SJ, Shimizu C, Shike H, Kanegaye JT, Newburger JW, Sundel RS, Brown PO, Burns JC, Relman DA. 
Gene expression patterns in Kawasaki disease reveal underlying processes. In press, Genome Biology. 
Sherlock SG. The Stanford microarray database. Nucl Acids Res. 2001;29:152-155.  
 
Taubert KA, Rowley AH, Shulman ST. A nationwide survey of Kawasaki disease and acute rheumatic fever. J 
Pediatr 1991;119:279-82. 
 
23. FUNDING SUPPORT FOR THIS STUDY 
NIH-NHLBI HL108460  
NIH –NHLBI HL103536 
Gordon and Marilyn Macklin Foundation 
The KD Foundation 
PCORI 
NIH-1R61HD105590 – 01 (PreVAIL) 
 
24. BIOLOGICAL MATERIALS TRANSFER AGREEMENT 
Signed with Stanford University for transfer of RNA, plasma, and urine. Signed with Columbia University for 
all patient samples. Signed with Imperial College, London, for transfer of clinical samples. 
 
25. INVESTIGATIONAL DRUG FACT SHEET AND IND/IDE HOLDER 
N/A 
 
26. IMPACT ON STAFF 
All nursing intervention required for participation in this study will be provided by the research nurse at 

 
 
Biomedical IRB Application Instructions 
Page 12 
RCHSD. Health Information Services will assist when Clarity Reports are needed to assess adverse events.  
 
27. CONFLICT OF INTEREST 
None 
 
28. SUPPLEMENTAL INSTRUCTIONS FOR CANCER-RELATED STUDIES 
N/A 
 
29. OTHER APPROVALS/REGULATED MATERIALS 
None 
 
30. PROCEDURES FOR SURROGATE CONSENT AND/OR DECISIONAL CAPACITY ASSESSMENT 
No surrogate consenting or decisional capacity assessments will be used.