Kawasaki DiseaseNCT05347901
Clinical Precise Diagnosis and Treatment in the Kawasaki Disease
An observational study of Kawasaki Disease, run by Affiliated Hospital of Nantong University at 4 sites in China.
Trial summary
The purpose of this project is to explore the differential gene expression profile of Kawasaki disease, and will explore the diagnosis and treatment targets related to coronary artery injury or kawasaki disease susceptibility, vascular damage, IVIG (intravenous immunoglobulin) treatment resistance, incomplete Kawasaki… Read more about this study
- Who is it for?
- Ages 1 month to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Kawasaki Disease
- What is being tested?
- Echocardiography, Genomics NGS sequencing
- How many people
- 800 participants
- Where
- 4 sitesChina
- Study dates
- 1 Aug 2021to 31 Jul 2024
- 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 1 month to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children under the care of consultant in hospital for Kawasaki disease
Who may be able to join
- Individual patient's medical file data confirmed the diagnosis of KD using diagnostic criteria issued by the American Heart Association in 2017;
- Patients were respond to IVIG treatment;
- the patients aged from 2 months to 14 years old;
- All included patients required to sign an informed consent form.
Who cannot join
- The patients with severe infections;
- The patients with a history of tuberculosis or recent close contact with tuberculosis;
- The patient vaccinated with live vaccine in 6 months;
- The patients with the application of hormone or other immunosuppressive agents;
- The patients didn"t want to signed informed consent.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Jiangsu Hailan People's Hospital
Haian, Jiangsu, 226000
Hao Fang, M.D.
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jangsu, 226000
Jianmei Zhao, PhD., 051385052399, zjmheart@163.com
- Recruiting
Nantong first People's Hospital
Nantong, Jiangsu, 226000
Tao Chen, M.D.
- Recruiting
Children's Hospital of Fudan University Qidong Branch
Qidong, Jiangsu, 226000
Ting Xu, M.D.
About this study
Official title: Clinical Precise Diagnosis and Treatment of Personalized Z-score Evaluation Combined With Genomic Analysis in the Repair of Coronary Artery Injury in Kawasaki Disease
The purpose of this project is to explore the differential gene expression profile of Kawasaki disease, and will explore the diagnosis and treatment targets related to coronary artery injury or kawasaki disease susceptibility, vascular damage, IVIG (intravenous immunoglobulin) treatment resistance, incomplete Kawasaki disease, etc.
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will acquire blood samples with complete clinical data and prognostic information. Using clinicopathology, molecular biology, gene diagnostics and other techniques to verify the expression differences of target genes and proteins and analyze their expression levels; To analyze the role of target genes and proteins in the occurrence and development of Kawasaki disease and their correlation with the risk of coronary artery injury. In vitro and in vivo KD (Kawasaki Disease) model was used to investigate the role of target genes in Kawasaki disease by gene interference and various molecular biological techniques.
- Conditions
- Kawasaki Disease
- Being tested
- Echocardiography, Genomics NGS sequencing
- 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.
Echocardiography, Genomics NGS sequencingDiagnostic test
The inner diameter of left main coronary artery, anterior descending branch, circumflex branch and right coronary artery was measured by echocardiography. Blood samples were send for genomics NGS sequencing
| Study group | Role | What they receive |
|---|---|---|
| Health Control | Health children with age and sex paired with experimental group Receives: Diagnostic Test: Echocardiography, Genomics NGS sequencing | |
| Kawasaki Disease | KD patients, with no congenital heart disease, metabolic disease or Immune deficiency disease. Receives: Diagnostic Test: Echocardiography, Genomics NGS sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Z-score of coronary artery
Calculate z-score by using LMS regression form echocardiography data
Measured: 2 weeks
Z-score of coronary artery
Calculate z-score by using LMS regression form echocardiography data
Measured: 4 weeks
Differential gene profile
Differential expression analysis of NGS sequencing in genomics
Measured: 0 week
Differential gene profile
Differential expression analysis of NGS sequencing in genomics
Measured: 1 week after IVIG treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 Aug 2021
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kawasaki DiseaseStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Fudan University Qidong Branch, Second Affiliated Hospital of Nantong University, Jiangsu Hai'an People's Hospital
- Responsible party
- Sponsor
- Investigators
- Jianmei Zhao, PhD., Study chair, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347901
- Sponsor's protocol ID
- LCYJ-A06
- Status last verified
- Apr 2023
- First submitted
- 23 Mar 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Precise Diagnosis and Treatment of Personalized Z-score Evaluation Combined With Genomic Analysis in the Repair of Coronary Artery Injury in Kawasaki Disease
- ClinicalTrials.gov ID
- NCT05347901
- Acronym / sponsor ID
- LCYJ-A06
- Conditions
- Kawasaki Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Fudan University Qidong Branch, Second Affiliated Hospital of Nantong University, Jiangsu Hai'an People's Hospital
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 26 Apr 2022 (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.
The purpose of this project is to explore the differential gene expression profile of Kawasaki disease, and will explore the diagnosis and treatment targets related to coronary artery injury or kawasaki disease susceptibility, vascular damage, IVIG (intravenous immunoglobulin) treatment resistance, incomplete Kawasaki disease, etc.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will acquire blood samples with complete clinical data and prognostic information. Using clinicopathology, molecular biology, gene diagnostics and other techniques to verify the expression differences of target genes and proteins and analyze their expression levels; To analyze the role of target genes and proteins in the occurrence and development of Kawasaki disease and their correlation with the risk of coronary artery injury. In vitro and in vivo KD (Kawasaki Disease) model was used to investigate the role of target genes in Kawasaki disease by gene interference and various molecular biological techniques.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Control | – | Diagnostic Test: Echocardiography, Genomics NGS sequencingHealth children with age and sex paired with experimental group |
| Kawasaki Disease | – | Diagnostic Test: Echocardiography, Genomics NGS sequencingKD patients, with no congenital heart disease, metabolic disease or Immune deficiency disease. |
Who may qualify
- Ages
- 1 month to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children under the care of consultant in hospital for Kawasaki disease
Key inclusion criteria (4 listed)
- Individual patient's medical file data confirmed the diagnosis of KD using diagnostic criteria issued by the American Heart Association in 2017;
- Patients were respond to IVIG treatment;
- the patients aged from 2 months to 14 years old;
- All included patients required to sign an informed consent form.
Key exclusion criteria (5 listed)
- The patients with severe infections;
- The patients with a history of tuberculosis or recent close contact with tuberculosis;
- The patient vaccinated with live vaccine in 6 months;
- The patients with the application of hormone or other immunosuppressive agents;
- The patients didn"t want to signed informed consent.
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 |
|---|---|---|
| Echocardiography, Genomics NGS sequencingThe inner diameter of left main coronary artery, anterior descending branch, circumflex branch and right coronary artery was measured by echocardiography. Blood samples were send for genomics NGS sequencing | Diagnostic test | Health Control, Kawasaki Disease |
Primary outcome
Z-score of coronary artery
Time frame: 2 weeks
Calculate z-score by using LMS regression form echocardiography data
Z-score of coronary artery
Time frame: 4 weeks
Calculate z-score by using LMS regression form echocardiography data
Differential gene profile
Time frame: 0 week
Differential expression analysis of NGS sequencing in genomics
Differential gene profile
Time frame: 1 week after IVIG treatment
Differential expression analysis of NGS sequencing in genomics
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
Jianmei Zhao, PhD. study chair
Affiliated Hospital of Nantong University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kawasaki Disease, run by Affiliated Hospital of Nantong University at 4 sites 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianmei Zhao, PhD. (051385052399, zjmheart@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Z-score of coronary artery (time frame: 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2023.