Cardiac Manifestation in Adolescent After Pfizer COVID-19 Injection in Thailand
Rationale Recently, a CDC advisory Committee on Immunization Practices identified a likely association between the 2 COVID-19 mRNA vaccines from Pfizer-BioNTech and Moderna and cases of myocarditis and pericarditis. For the cardiovascular system, 4863 adverse events (AEs) were reported from the Pfizer vaccine. Common findings observed with vaccines under study were tachycardia(16.41%), flushing (12.17%), hypertension (5.82%), hypotension (3.6%), and increased heart rate (9.03%). In this study we characterized, classified, evaluate the dynamic of cardiac function and ECG abnormality after the Pfizer vaccine injection.
This is a prospective cohort study. All participants aged 13-18 years old and above who visited the second dose Pfizer covid-19 vaccine injection to determine cardiac manifestation.
Methods for analyzing research data The data will be collected from students enrollment at Kong thabbok upatham changkol kho so tho bo school and Wachirathamsatit school. The participant's history, physical exam, and laboratory data will be reviewed and data will be extracted based on the case record form (CRF). All data will be stored securely and analyzed using the SPSS® Statistics Version 23 developed by IBM®. Data entry will be carried out using coding and verification. Quantitative data will be expressed as mean with standard deviation (SD) or median (IQR) and qualitative data will be presented as a number of observations with percentage (%). Descriptive statistics will be used to summarize the baseline values and demographic data.
All p-values will be derived using the 2-tailed testing, and statistical significance will be set at 0.05 probability. All the categorical variables will be analyzed using the chi-square (x2) or Fisher's exact test whichever is appropriate. Normality of the distribution will be tested for the continuous variable using the Kolmogorov- Smirnov test. All the variables with normal distributions will be compared using the independent t-test and will be reported as mean ± standard deviation (SD). The variables that do not pass the normality test will be compared by means of the Mann-Whitney U test and will be reported as the median and interquartile range (IQR).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Data Collection Methods
- Participants' demographics will be collected at baseline using case record form.
- Laboratory tests include: at 3 clinical visits (Baseline, Day3, Day7 and Day 14 (optional if have cardiac manifestation) after 2nd dose of Pfizer COVID-19 vaccine) 2.1. Cardiac biomarker (Troponin-T, CK-MB) 2.2. Echocardiography 2.3. ECG (Electrocardiography)
After getting approval from the Ethics Committee and before the start of the trial, the study team informed the interesting participants about the study by invitation letter with ZOOM or line meeting. Informed consent printed to the parents who interested in this project and bring to the team investigator before enrollment. A contact address and phone number will be provided for the interesting participants to call for more information about the study.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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BAngkok, Tailandia, 10400
- Faculty of Tropical Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Student age 13-18 who received 1st dose of pfizer COVID-19 vaccine from
- Kong thabbok upatham changkol kho so tho bo school
- Wachirathamsatit school
Descripción
Inclusion Criteria:
- Age 13-18 years old
- Both males and females
- Received 1st dose Pfizer COVID-19 vaccine injection
Exclusion Criteria:
- Unable to obtain written informed consent from the participants or their legal representatives
- History of cardiomyopathy, tuberculous pericarditis, and constrictive pericarditis
- Severe allergic reaction to COVID-19 vaccine
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number and percentage of participant with cardiac manifestation after Pfizer COVID-19 vaccine injection at baseline
Periodo de tiempo: Day 0
|
cardiac manifestation defined as sinus tachycardia, hypertension at baseline
|
Day 0
|
|
Number and percentage of participant with cardiac manifestation after Pfizer COVID-19 vaccine injection at day 3
Periodo de tiempo: Day 3
|
cardiac manifestation defined as sinus tachycardia, hypertension at day 3
|
Day 3
|
|
Number and percentage of participant with cardiac manifestation after Pfizer COVID-19 vaccine injection at day 7
Periodo de tiempo: Day 7
|
cardiac manifestation defined as sinus tachycardia, hypertension at day 7
|
Day 7
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number and percentage of participant with Myocarditis after Pfizer COVID-19 vaccine injection at baseline
Periodo de tiempo: Day 0
|
frequency (%) of participant with myocarditis at baseline
|
Day 0
|
|
Number and percentage of participant with Myocarditis after Pfizer COVID-19 vaccine injection at day 3
Periodo de tiempo: Day 3
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frequency (%) of participant with myocarditis at day 3
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Day 3
|
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Number and percentage of participant with Myocarditis after Pfizer COVID-19 vaccine injection at day 7
Periodo de tiempo: Day 7
|
frequency (%) of participant with myocarditis at day 7
|
Day 7
|
|
Number and percentage of participant with pericarditis after Pfizer COVID-19 vaccine injection at baseline
Periodo de tiempo: Day 0
|
frequency (%) of participant with pericarditis at baseline
|
Day 0
|
|
Number and percentage of participant with pericarditis after Pfizer COVID-19 vaccine injection at day 3
Periodo de tiempo: Day 3
|
frequency (%) of participant with pericarditis at day 3
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Day 3
|
|
Number and percentage of participant with pericarditis after Pfizer COVID-19 vaccine injection at day 7
Periodo de tiempo: Day 7
|
frequency (%) of participant with pericarditis at day 7
|
Day 7
|
|
Number and percentage of participant abnormal cardiac biomarker after Pfizer COVID-19 vaccine injection at baseline
Periodo de tiempo: Day 0
|
frequency (%) of participant with abnormal cardiac biomarker (Troponin and CKMB) at baseline
|
Day 0
|
|
Number and percentage of participant abnormal cardiac biomarker after Pfizer COVID-19 vaccine injection at day 3
Periodo de tiempo: Day 3
|
frequency (%) of participant with abnormal cardiac biomarker (Troponin and CKMB) at day 3
|
Day 3
|
|
Number and percentage of participant abnormal cardiac biomarker after Pfizer COVID-19 vaccine injection at day 7
Periodo de tiempo: Day 7
|
frequency (%) of participant with abnormal cardiac biomarker (Troponin and CKMB) at day 7
|
Day 7
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Chayasin Mansanguan, M.D., Mahidol University
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Cardiac and pfiizer
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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