Cardiac Manifestation in Adolescent After Pfizer COVID-19 Injection in Thailand

NCT05288231 | Completed

• 1 other identifier: Cardiac and pfiizer
• Study Type: observational
• Target: 314
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Covid-19 Vaccine

Keywords

pfizer-BioNTech Covid-19 vaccine; adult; Thailand; myocarditis; cardiac manifestation; Covid-19 vaccine

Outcome Measures

Primary Outcomes (3)

• Number and percentage of participant with cardiac manifestation after Pfizer COVID-19 vaccine injection at baseline

  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

  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

  cardiac manifestation defined as sinus tachycardia, hypertension at day 7

  Day 7

Secondary Outcomes (9)

• Number and percentage of participant with Myocarditis after Pfizer COVID-19 vaccine injection at baseline

  Day 0

• Number and percentage of participant with Myocarditis after Pfizer COVID-19 vaccine injection at day 3

  Day 3

• Number and percentage of participant with Myocarditis after Pfizer COVID-19 vaccine injection at day 7

  Day 7

• Number and percentage of participant with pericarditis after Pfizer COVID-19 vaccine injection at baseline

  Day 0

• Number and percentage of participant with pericarditis after Pfizer COVID-19 vaccine injection at day 3

  Day 3

Interventions

Diagnostic of ECG DIAGNOSTIC_TEST

All participants who enrolled in the study will be performed ECG, cardiac enzyme and echocardiography

Also known as: Diagnostic of cardiac enzyme, Diagnostic of echocardiography

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• Age 13-18 years old
• Both males and females
• Received 1st dose Pfizer COVID-19 vaccine injection

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Tropical Medicine

Bangkok, 10400, Thailand

Location

Related Publications (1)

• Mansanguan S, Charunwatthana P, Piyaphanee W, Dechkhajorn W, Poolcharoen A, Mansanguan C. Cardiovascular Manifestation of the BNT162b2 mRNA COVID-19 Vaccine in Adolescents. Trop Med Infect Dis. 2022 Aug 19;7(8):196. doi: 10.3390/tropicalmed7080196.

  PMID: 36006288 DERIVED

MeSH Terms

Conditions

Myocarditis

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Study Officials

• Chayasin Mansanguan, M.D.

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 21, 2022
• Study Start: November 3, 2021
• Primary Completion: November 29, 2021
• Study Completion: March 15, 2022
• Last Updated: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 2 years after publication

Locations

TH (1)