Mucocutaneous Lymph Node SyndromeNCT03880929
Epidemiologic Features of Kawasaki Disease in Shanghai From 2013 Through 2017
An observational study of Mucocutaneous Lymph Node Syndrome, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
To investigate the epidemiologic features of Kawasaki disease (KD) in Shanghai from 2013 through 2017 and identify the risk factors for coronary artery lesions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mucocutaneous Lymph Node Syndrome
- How many people
- 4,533 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 1 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All hospitalized patients diagnosed with Kawasaki disease in Shanghai from 2013 through 2017
Who may be able to join
- meeting the diagnostic criteria for Kawasaki disease released by American Heart Association 2017
Who cannot join
- not in acute phase;
- repeated cases;
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201122
About this study
To investigate the epidemiologic features of Kawasaki disease (KD) in Shanghai from 2013 through 2017 and identify the risk factors for coronary artery lesions.
Read the detailed description
Based on the KD research group network established during the first survey in Shanghai, a set of questionnaires and diagnostic guidelines for KD will be sent to 50 hospitals providing pediatric medical care in Shanghai, China. Medical records of participants with KD diagnosed from January 2013 through December 2017 will be retrospectively analyzed. Data are collected by pediatricians, including demographic information, clinical manifestations, prognosis, laboratory indexes, treatment and echocardiographic findings.
Age and seasonal distribution at onset, treatment and cardiac abnormalities wil be described. Univariate and multivariate analyses will be performed to identify risk factors for coronary artery lesions.
- Conditions
- Mucocutaneous Lymph Node Syndrome
- Being tested
- no intervention
- Keywords
- kawasaki disease, coronary artery lesion, epidemiology
- Medical subject headings
- Mucocutaneous Lymph Node Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of coronary artery lesions
Coronary artery lesions were identified with two-dimensional echocardiography in the acute phase (within one month of onset). Participants were considered to have coronary artery lesions if the luminal diameter of a coronary artery was >3.0 mm in children aged younger than 5 years or >4.0 mm in those aged 5 years and older, or when the internal diameter of a segment was ≥1.5 times that of an adjacent segment.
Measured: from admission to one month after onset
Secondary outcomes (2)
Incidence of intravenous immunoglobulin resistance
Ear temperature was measured each day during hospitalization. Intravenous immunoglobulin (IVIG) resistance was defined as persistent fever (>38°C) after 36 hours of completion of initial IVIG infusion or recurrent fever requiring another dose of IVIG or other adjunctive therapies.
Measured: from admission to discharge (about two weeks after onset)
Risk factors associated with coronary artery lesions
Multivariate logistic regressions were performed to identify risk factors that were independently associated with coronary artery lesions. Odds ratio and 95% CI were calculated for each variable.
Measured: from admission to one month after onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start1 Jun 2017
- Primary completion1 Jan 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mucocutaneous Lymph Node SyndromeStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 4,533 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Children's Hospital, Shanghai Children's Medical Center, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Fang Liu, Dr., Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880929
- Sponsor's protocol ID
- KD EP4
- Status last verified
- Jul 2023
- First submitted
- 6 Mar 2019
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen JJ, Ma XJ, Liu F, Yan WL, Huang MR, Huang M, Huang GY; Shanghai Kawasaki Disease Research Group. Epidemiologic Features of Kawasaki Disease in Shanghai From 2008 Through 2012. Pediatr Infect Dis J. 2016 Jan;35(1):7-12. doi: 10.1097/INF.0000000000000914.
PubMed 26372452McCrindle BW, Rowley AH, Newburger JW, Burns JC, Bolger AF, Gewitz M, Baker AL, Jackson MA, Takahashi M, Shah PB, Kobayashi T, Wu MH, Saji TT, Pahl E; American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee of the Council on Cardiovascular Disease in the Young; Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Surgery and Anesthesia; and Council on Epidemiology and Prevention. Diagnosis, Treatment, and Long-Term Management of Kawasaki Disease: A Scientific Statement for Health Professionals From the American Heart Association. Circulation. 2017 Apr 25;135(17):e927-e999. doi: 10.1161/CIR.0000000000000484. Epub 2017 Mar 29.
PubMed 28356445JCS Joint Working Group. Guidelines for diagnosis and management of cardiovascular sequelae in Kawasaki disease (JCS 2008)--digest version. Circ J. 2010 Sep;74(9):1989-2020. doi: 10.1253/circj.cj-10-74-0903. Epub 2010 Aug 18. No abstract available.
PubMed 20724794
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic Features of Kawasaki Disease in Shanghai From 2013 Through 2017
- ClinicalTrials.gov ID
- NCT03880929
- Acronym / sponsor ID
- KD EP4
- Conditions
- Mucocutaneous Lymph Node Syndrome
- Keywords
- kawasaki disease, coronary artery lesion, epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,533 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Children's Hospital, Shanghai Children's Medical Center, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the epidemiologic features of Kawasaki disease (KD) in Shanghai from 2013 through 2017 and identify the risk factors for coronary artery lesions.
Detailed description
Based on the KD research group network established during the first survey in Shanghai, a set of questionnaires and diagnostic guidelines for KD will be sent to 50 hospitals providing pediatric medical care in Shanghai, China. Medical records of participants with KD diagnosed from January 2013 through December 2017 will be retrospectively analyzed. Data are collected by pediatricians, including demographic information, clinical manifestations, prognosis, laboratory indexes, treatment and echocardiographic findings.
Age and seasonal distribution at onset, treatment and cardiac abnormalities wil be described. Univariate and multivariate analyses will be performed to identify risk factors for coronary artery lesions.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All hospitalized patients diagnosed with Kawasaki disease in Shanghai from 2013 through 2017
Key inclusion criteria (1 listed)
- meeting the diagnostic criteria for Kawasaki disease released by American Heart Association 2017
Key exclusion criteria (2 listed)
- not in acute phase;
- repeated cases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
Incidence of coronary artery lesions
Time frame: from admission to one month after onset
Coronary artery lesions were identified with two-dimensional echocardiography in the acute phase (within one month of onset). Participants were considered to have coronary artery lesions if the luminal diameter of a coronary artery was >3.0 mm in children aged younger than 5 years or >4.0 mm in those aged 5 years and older, or when the internal diameter of a segment was ≥1.5 times that of an adjacent segment.
2 secondary outcomes
Incidence of intravenous immunoglobulin resistance
Time frame: from admission to discharge (about two weeks after onset)
Risk factors associated with coronary artery lesions
Time frame: from admission to one month after onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Background: PubMed 26372452Chen JJ, Ma XJ, Liu F, Yan WL, Huang MR, Huang M, Huang GY; Shanghai Kawasaki Disease Research Group. Epidemiologic Features of Kawasaki Disease in Shanghai From 2008 Through 2012. Pediatr Infect Dis J. 2016 Jan;35(1):7-12. doi: 10.1097/INF.0000000000000914.
- Background: PubMed 28356445McCrindle BW, Rowley AH, Newburger JW, Burns JC, Bolger AF, Gewitz M, Baker AL, Jackson MA, Takahashi M, Shah PB, Kobayashi T, Wu MH, Saji TT, Pahl E; American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee of the Council on Cardiovascular Disease in the Young; Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Surgery and Anesthesia; and Council on Epidemiology and Prevention. Diagnosis, Treatment, and Long-Term Management of Kawasaki Disease: A Scientific Statement for Health Professionals From the American Heart Association. Circulation. 2017 Apr 25;135(17):e927-e999. doi: 10.1161/CIR.0000000000000484. Epub 2017 Mar 29.
- Background: PubMed 20724794JCS Joint Working Group. Guidelines for diagnosis and management of cardiovascular sequelae in Kawasaki disease (JCS 2008)--digest version. Circ J. 2010 Sep;74(9):1989-2020. doi: 10.1253/circj.cj-10-74-0903. Epub 2010 Aug 18. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fang Liu, Dr. principal investigator
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mucocutaneous Lymph Node Syndrome, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of coronary artery lesions (time frame: from admission to one month after onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03880929, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.