Construction of a Prospective Cohort Database for the Perioperative Period of Cardiac Surgery
Cardiovascular disease (CVD) is the leading cause of global morbidity and mortality, with its prevalence increasing significantly from 1990 to 2019. Establishing a comprehensive cardiac surgery database is crucial for exploring perioperative prognostic factors and improving clinical outcomes.
This muti-center, prospective observational study aims to construct a prospective cohort database for perioperative cardiac surgery. We plan to enroll adult patients who undergo cardiac surgery with cardiopulmonary bypass at the Second Affiliated Hospital of Zhejiang University and other hospitals from May 1, 2026 to December 31, 2031. Multi-dimensional perioperative data, including laboratory tests, hemodynamics, intraoperative echocardiography, and perioperative medications, will be collected and integrated, along with epidemiological data, clinical diagnosis and treatment information, multimodal data, and follow-up outcomes. An interconnected big data sharing platform will also be built.
This database will provide a valuable resource for multi-level researches such as perioperative risk assessment, individualized prevention, precise diagnosis and treatment, and therapeutic efficacy monitoring. It will also help optimize surgical and perioperative management, improve the quality of cardiac surgery, and provide evidence for the refinement of China's healthcare system, ultimately enhancing perioperative safety and rehabilitation efficiency of patients.
연구 개요
상세 설명
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Min Yan, Doctor
- 전화번호: 15888210247
- 이메일: zryanmin@zju.edu.cn
연구 장소
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Zhejiang
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Hangzhou, Zhejiang, 중국
- 모병
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients undergoing cardiac surgery from May 1, 2026 to December 31, 2031
Exclusion Criteria:
- Refusal to provide informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Perioperative Observation Group
Patients undergoing cardiac surgery with cardiopulmonary bypass during the perioperative period (including, but not limited to, valve surgery, coronary artery bypass grafting, and combined procedures that require cardiopulmonary bypass)
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Cardiac surgey
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of major adverse cardiac and cerebrovascular events (MACCE)
기간: 4, 12 weeks and 1years after surgery
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Myocardial infarction; New-onset stroke: new irreversible neurological impairment confirmed by radiological examination or autopsy showing a new cerebral lesion; Death
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4, 12 weeks and 1years after surgery
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Incidence of Perioperative Transfusion of Allogeneic Blood Products
기간: 30 days after surgery
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Allogeneic red blood cells, plasma, platelets, and blood coagulation factors
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30 days after surgery
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Amount of Allogeneic Blood Products Transfused During the Perioperative Period
기간: 30 days after surgery
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Allogeneic red blood cells, plasma, platelets, and blood coagulation factors
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30 days after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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수술 후 4주 및 12주 이내 계획되지 않은 재입원 발생률
기간: 수술 후 4주 및 12주째
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계획되지 않은 병원 재입원
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수술 후 4주 및 12주째
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Incidence of perioperative myocardial infarction
기간: 4, 12 weeks and 1years after surgery
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Myocardial infarction
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4, 12 weeks and 1years after surgery
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Incidence of New-onset stroke
기간: 4, 12 weeks and 1years after surgery
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New-onset stroke: new irreversible neurological impairment confirmed by radiological examination or autopsy showing a new cerebral lesion
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4, 12 weeks and 1years after surgery
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Incidence of death
기간: 4, 12 weeks and 1years after surgery
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death
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4, 12 weeks and 1years after surgery
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Incidence of acute kidney injury
기간: 7days after suegery
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acute kidney injury was defined by guidelines of kindey disease：improving global outcomes（KIDGO）
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7days after suegery
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Incidence of infectious complications
기간: 4, 12 weeks and 1years after surgery
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Infectious complications include, but are not limited to, pneumonia, surgical site infection, etc.
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4, 12 weeks and 1years after surgery
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Length of hospital stay
기간: Through patients discharge, an average of 7 days after surgery
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Length of hospital stay
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Through patients discharge, an average of 7 days after surgery
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Hospitalization costs
기간: Through patients discharge, an average of 7 days after surgery
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Hospitalization costs
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Through patients discharge, an average of 7 days after surgery
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Quality of life scores
기간: at 4, 12 weeks and 1 years after surgery
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Quality of life was assessed using the EuroQol Five-Dimensional Questionnaire (EQ-5D) EuroQol Five-Dimensional Questionnaire (EQ-5D): The EQ-5D includes a visual analog scale (EQ-VAS) ranging from 0 to 100, where higher scores indicate better health status. |
at 4, 12 weeks and 1 years after surgery
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Quality of life scores
기간: at 4, 12 weeks and 1 years after surgery
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Quality of life was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Kansas City Cardiomyopathy Questionnaire (KCCQ): The KCCQ consists of 23 items that quantify the following domains: physical limitations, symptoms (including symptom frequency, severity, and change over time), self-efficacy, social function, and quality of life. The total score ranges from 0 to 100, with higher scores representing better quality of life. |
at 4, 12 weeks and 1 years after surgery
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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 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. .