- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04413071
Cardiac COVID-19 Health Care Workers (CCC)
Cardiac Involvement in Coronavirus (SARS-Cov-2) Infected Health Care Workers: The CCC Study
연구 개요
상태
상세 설명
Most people infected with SARS-CoV-2 experience mild, self-limiting symptoms that have been managed in an outpatient setting and therefore have not undergone routine cardiac evaluation with EKG or cardiac imaging test. Similarly, although the emphasis has been placed on evaluating patients with severe respiratory symptoms, most of these patients have also not undergone cardiac imaging tests and; therefore, in both scenarios, possible myocarditis has not routinely evaluated.
The present study is designed to characterize cardiac involvement in individuals who have overcome the SARS-CoV-2 infection.
For that aim, the study is designed as an observational cross-sectional study. The target population are HUSA healthcare workers who have overcome SARS-CoV-2 infection, either symptomatic or asymptomatic, either having required hospital admission or not. Participants will undergo a clinical evaluation, electrocardiogram (EKG), cardiac magnetic resonance (CMR) and blood analysis including NT-proBNP, troponin, cellular and humoral immunity and genetics.
Main objectives of the study are to address the prevalence of myocardial damage suggestive of myocarditis and to address the prevalence of pericarditis in HUSA health care workers; both related to the systemic immune response to SARS-CoV-2 infection. As secondary objectives the study will further address other cardiac affections including: rhythm or conduction disorders, ischemic heart disease, dilatation of the right chambers, valve disease and will analyze the relationship between humoral and cellular immunity and the presence of cardiac involvement, and the genetic susceptibility in the development of cardiac involvement after SARS-CoV-2 infection.
The study will recruit 141 participants: 47 symptomatic hospitalized health care workers, 47 asymptomatic non-hospitalized health care workers, 47 asymptomatic health care workers
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Salamanca, 스페인, 37007
- University Hospital of Salamanca
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Have overcome the SARS-CoV-2 infection meeting any of the following criteria (i) positive result on a reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of a specimen collected on a nasopharyngeal swab followed by a second negative RT-PCR and at least 14 days from this negative RT-PCR; (ii) presence of IgM antibodies and negative RT-PCR after the antibody assessment; (iii) presence of neutralizing IgG antibodies and absence of IgM.
- stable clinical situation, which allows performing a CMR.
- signature of informed consent.
Exclusion Criteria:
- Presence of IgM antibodies without negative subsequent RT-PCR.
- Contraindications to perform RMC: (i) gadolinium allergy, (ii) presence of metallic material in the body, such as plates, screws, incompatible pacemakers, etc. (iii) claustrophobia, (iv) severe kidney failure, (v) severe liver failure, (vi) sickle cell anemia
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 단면
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Health care workers
Health care workers from the University Hospital of Salamanca who have passed SARS-CoV-2 infection.
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This is an observational design.
Participants have passed infection from SARS-CoV-2 and a cardiac assessment is performed.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Myocarditis
기간: up to 3 months
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Prevalence of myocardial damage suggestive of myocarditis assessed by cardiac magnetic resonance
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up to 3 months
|
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Pericarditis
기간: up to 3 months
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Prevalence of pericarditis assessed by clinical criteria
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up to 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Atrial fibrillation
기간: up to 3 months
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Prevalence of atrial fibrillation on EKG
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up to 3 months
|
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Ischemic heart disease
기간: up to 3 months
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Prevalence of ischemic heart disease assessed by cardiac magnetic resonance
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up to 3 months
|
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Dilatation of right heart chambers
기간: up to 3 months
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Prevalence of dilatation of right heart chambers assessed by cardiac magnetic resonance
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up to 3 months
|
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Valvular hear disease
기간: up to 3 months
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Prevalence of valvular heart disease assessed by cardiac magnetic resonance
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up to 3 months
|
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Rhythm disorders
기간: up to 3 months
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Prevalence of prolonged QT interval on EKG
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up to 3 months
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공동 작업자 및 조사자
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
- CCC_2020
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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