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

29. mai 2022 oppdatert av: Chayasin Mansanguan, Mahidol University

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).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

314

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Thailand
      • BAngkok, Thailand, 10400
        • Faculty of Tropical Medicine

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

13 år til 18 år (Barn, Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number and percentage of participant with cardiac manifestation after Pfizer COVID-19 vaccine injection at baseline
Tidsramme: 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
Tidsramme: 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
Tidsramme: Day 7
cardiac manifestation defined as sinus tachycardia, hypertension at day 7
Day 7

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number and percentage of participant with Myocarditis after Pfizer COVID-19 vaccine injection at baseline
Tidsramme: 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
Tidsramme: Day 3
frequency (%) of participant with myocarditis at day 3
Day 3
Number and percentage of participant with Myocarditis after Pfizer COVID-19 vaccine injection at day 7
Tidsramme: 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
Tidsramme: 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
Tidsramme: Day 3
frequency (%) of participant with pericarditis at day 3
Day 3
Number and percentage of participant with pericarditis after Pfizer COVID-19 vaccine injection at day 7
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Day 7
frequency (%) of participant with abnormal cardiac biomarker (Troponin and CKMB) at day 7
Day 7

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Mahidol University

Etterforskere

  • Hovedetterforsker: Chayasin Mansanguan, M.D., Mahidol University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. november 2021

Primær fullføring (Faktiske)

29. november 2021

Studiet fullført (Faktiske)

15. mars 2022

Datoer for studieregistrering

Først innsendt

17. mars 2022

Først innsendt som oppfylte QC-kriteriene

17. mars 2022

Først lagt ut (Faktiske)

21. mars 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juni 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. mai 2022

Sist bekreftet

1. mai 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Cardiac and pfiizer

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Data or leftover specimens will be shared for future study ONLY subjects who consent allow using their specimens. Sharing will be done without specimen identification.

IPD-delingstidsramme

2 years after publication

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Covid-19-vaksine

Kliniske studier på Diagnostic of ECG

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Burkina Faso

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

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