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.
調査の概要
詳細な説明
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Min Yan, Doctor
- 電話番号:15888210247
- メール:zryanmin@zju.edu.cn
研究場所
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国
- 募集
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients undergoing cardiac surgery from May 1, 2026 to December 31, 2031
Exclusion Criteria:
- Refusal to provide informed consent
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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)
|
Cardiac surgey
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of major adverse cardiac and cerebrovascular events (MACCE)
時間枠:4, 12 weeks and 1years after surgery
|
Myocardial infarction; New-onset stroke: new irreversible neurological impairment confirmed by radiological examination or autopsy showing a new cerebral lesion; Death
|
4, 12 weeks and 1years after surgery
|
|
Incidence of Perioperative Transfusion of Allogeneic Blood Products
時間枠:30 days after surgery
|
Allogeneic red blood cells, plasma, platelets, and blood coagulation factors
|
30 days after surgery
|
|
Amount of Allogeneic Blood Products Transfused During the Perioperative Period
時間枠:30 days after surgery
|
Allogeneic red blood cells, plasma, platelets, and blood coagulation factors
|
30 days after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
手術後4週間および12週間以内の計画外の病院再入院発生率
時間枠:手術後4週間および12週間後
|
計画外の病院再入院
|
手術後4週間および12週間後
|
|
Incidence of perioperative myocardial infarction
時間枠:4, 12 weeks and 1years after surgery
|
Myocardial infarction
|
4, 12 weeks and 1years after surgery
|
|
Incidence of New-onset stroke
時間枠:4, 12 weeks and 1years after surgery
|
New-onset stroke: new irreversible neurological impairment confirmed by radiological examination or autopsy showing a new cerebral lesion
|
4, 12 weeks and 1years after surgery
|
|
Incidence of death
時間枠:4, 12 weeks and 1years after surgery
|
death
|
4, 12 weeks and 1years after surgery
|
|
Incidence of acute kidney injury
時間枠:7days after suegery
|
acute kidney injury was defined by guidelines of kindey disease:improving global outcomes(KIDGO)
|
7days after suegery
|
|
Incidence of infectious complications
時間枠:4, 12 weeks and 1years after surgery
|
Infectious complications include, but are not limited to, pneumonia, surgical site infection, etc.
|
4, 12 weeks and 1years after surgery
|
|
Length of hospital stay
時間枠:Through patients discharge, an average of 7 days after surgery
|
Length of hospital stay
|
Through patients discharge, an average of 7 days after surgery
|
|
Hospitalization costs
時間枠:Through patients discharge, an average of 7 days after surgery
|
Hospitalization costs
|
Through patients discharge, an average of 7 days after surgery
|
|
Quality of life scores
時間枠:at 4, 12 weeks and 1 years after surgery
|
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
|
|
Quality of life scores
時間枠:at 4, 12 weeks and 1 years after surgery
|
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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。