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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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TCTR |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
TCTR20240405001 |
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Date of registration:
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05/04/2024 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Myocardial scar rate from myocarditis on Cardiac Magnetic Resonance Imaging: Multisystem Inflammatory Syndrome (MIS-C) and COVID-19 vaccine-associated pattern in pediatric patients.
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Scientific title:
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Myocardial scar rate from myocarditis on Cardiac Magnetic Resonance Imaging: Multisystem Inflammatory Syndrome (MIS-C) and COVID-19 vaccine-associated pattern in pediatric patients. |
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Date of first enrolment:
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01/11/2023 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://www.thaiclinicaltrials.org/show/TCTR20240405001 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Suvicha
Khampunnip |
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Address:
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315 Rajvithi road, Rajthevi district
10400
Bangkok
Thailand |
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Telephone:
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0879978324 |
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Email:
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canjang@hotmail.com |
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Affiliation:
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Phramongkutklao hospital |
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Name:
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Suvicha
Khampunnip |
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Address:
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315 Rajvithi road, Rajthevi district
10400
Bangkok
Thailand |
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Telephone:
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0879978324 |
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Email:
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canjang@hotmail.com |
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Affiliation:
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Phramongkutklao hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: All patients aged younger than 18 years old who diagnosed as Vaccine-associated myocarditis or myocarditis due to MIS-C induced.
Exclusion criteria: Patients with underlying structural heart disease
Age minimum:
1 Days
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multisystem inflammatory syndrome in children
covid vaccine
myocarditis
cardiac MRI
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Patients with myocarditis either from covid19 vaccine or MISC.
Multisystem inflammatory syndrome in children
covid vaccine
myocarditis
cardiac MRI
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Intervention(s)
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MIS-C assiciated myocarditis,Vaccine-associated myocarditis
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Prevention,Prevention
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Pediatric patients with history of COVID-19 infection from positive RT-PCR within 4-6 weeks who had fever of at least 38 degree celsius more than 24 hrs and had more than 2 system involvements including gastrointestinal tract, swollen and redness of arms and legs, conjunctivitis, lymphadenopathy and central nervous system.,Patients with history of mRNA COVID-19 vaccine administration within past 2 weeks with clinical of shortness of breath, chest pain, palpitation with abnormal EKG, cardiac enzyme and inflammatory biomarker.
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Primary Outcome(s)
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MISC Myocardial fibrosis at 4-6 weeks after onset of symptoms Rate of LGE on MRI,VAM Myocardial fibrosis at 2weeks after vaccination Rate of LGE on MRI
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Secondary Outcome(s)
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Myocardial dysfuntion within 8 weeks after MRI LVEF on echocardiogram
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Secondary ID(s)
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Nil Known
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Source(s) of Monetary Support
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Self
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Ethics review
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Status: Submitted, approved
Approval date: 20/10/2023
Contact:
irbrta@yahoo.com
The Institutional Review Board, Royal Thai Army Medical Department
027634297 Ext.
irbrta@yahoo.com
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Results
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Results available:
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Yes |
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Date Posted:
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31/01/2024 |
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Date Completed:
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30/11/2023 |
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URL:
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