Cardiac Manifestation in Adolescent After Pfizer COVID-19 Injection in Thailand
Condition: Covid-19 Vaccine
MeSH terms: COVID-19
Study type: Observational

Summary: 
      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).
    

Detailed description: 
      Data Collection Methods

        1. Participants' demographics will be collected at baseline using case record form.

        2. 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.
    

Intervention name(s): Diagnostic of ECG
Intervention type(s): Diagnostic Test
Intervention description(s): All participants who enrolled in the study will be performed ECG, cardiac enzyme and echocardiography
Other intervention name(s): Diagnostic of cardiac enzyme; Diagnostic of echocardiography
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Student age 13-18 who received 1st dose of pfizer COVID-19 vaccine from

          1. Kong thabbok upatham changkol kho so tho bo school

          2. Wachirathamsatit school
      
Keywords: pfizer-BioNTech Covid-19 vaccine; adult; Thailand; myocarditis; cardiac manifestation; Covid-19 vaccine