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

NCT ID: NCT05288231

Last Updated: 2022-06-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 314 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-03
• Study Completion Date: 2022-03-15

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).

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.

Conditions

Covid-19 Vaccine

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Diagnostic of ECG

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Diagnostic of cardiac enzyme; Diagnostic of echocardiography

Eligibility Criteria

Inclusion Criteria

1. Age 13-18 years old

2. Both males and females

3. Received 1st dose Pfizer COVID-19 vaccine injection

Exclusion Criteria

1. Unable to obtain written informed consent from the participants or their legal representatives

2. History of cardiomyopathy, tuberculous pericarditis, and constrictive pericarditis

3. Severe allergic reaction to COVID-19 vaccine

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Chayasin Mansanguan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chayasin Mansanguan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Faculty of Tropical Medicine

Bangkok, , Thailand

Countries

Thailand

References

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.

Reference Type: DERIVED

PMID: 36006288 (View on PubMed)

Other Identifiers

Cardiac and pfiizer

Identifier Type: -

Identifier Source: org_study_id