- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05288231
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).
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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BAngkok, 태국, 10400
- Faculty of Tropical Medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number and percentage of participant with cardiac manifestation after Pfizer COVID-19 vaccine injection at baseline
기간: Day 0
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cardiac manifestation defined as sinus tachycardia, hypertension at baseline
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Day 0
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Number and percentage of participant with cardiac manifestation after Pfizer COVID-19 vaccine injection at day 3
기간: Day 3
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cardiac manifestation defined as sinus tachycardia, hypertension at day 3
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Day 3
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Number and percentage of participant with cardiac manifestation after Pfizer COVID-19 vaccine injection at day 7
기간: Day 7
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cardiac manifestation defined as sinus tachycardia, hypertension at day 7
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Day 7
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number and percentage of participant with Myocarditis after Pfizer COVID-19 vaccine injection at baseline
기간: Day 0
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frequency (%) of participant with myocarditis at baseline
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Day 0
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Number and percentage of participant with Myocarditis after Pfizer COVID-19 vaccine injection at day 3
기간: 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
기간: Day 7
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frequency (%) of participant with myocarditis at day 7
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Day 7
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Number and percentage of participant with pericarditis after Pfizer COVID-19 vaccine injection at baseline
기간: Day 0
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frequency (%) of participant with pericarditis at baseline
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Day 0
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Number and percentage of participant with pericarditis after Pfizer COVID-19 vaccine injection at day 3
기간: Day 3
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frequency (%) of participant with pericarditis at day 3
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Day 3
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Number and percentage of participant with pericarditis after Pfizer COVID-19 vaccine injection at day 7
기간: Day 7
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frequency (%) of participant with pericarditis at day 7
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Day 7
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Number and percentage of participant abnormal cardiac biomarker after Pfizer COVID-19 vaccine injection at baseline
기간: Day 0
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frequency (%) of participant with abnormal cardiac biomarker (Troponin and CKMB) at baseline
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Day 0
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Number and percentage of participant abnormal cardiac biomarker after Pfizer COVID-19 vaccine injection at day 3
기간: Day 3
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frequency (%) of participant with abnormal cardiac biomarker (Troponin and CKMB) at day 3
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Day 3
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Number and percentage of participant abnormal cardiac biomarker after Pfizer COVID-19 vaccine injection at day 7
기간: Day 7
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frequency (%) of participant with abnormal cardiac biomarker (Troponin and CKMB) at day 7
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Day 7
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공동 작업자 및 조사자
수사관
- 수석 연구원: Chayasin Mansanguan, M.D., Mahidol University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Cardiac and pfiizer
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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