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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Coronary Heart Disease; Aortic Diseases; Valve Heart Disease
• Intervention / Treatment: Procedure: Cardiac surgey

Detailed Description

1. Establish a cohort of perioperative surgical patients across multiple medical centers, tracking them from enrollment through 1 year post-surgery, and build a database of data relevant to patient outcomes; 2. Investigate the impact of preoperative psychological and physical factors on short-term postoperative complications in surgical patients, develop predictive models, and conduct prospective validation; 3. Investigate the impact of preoperative psychological, physical, and social factors on long-term postoperative complications; 4. Investigate the incidence of acute and chronic postoperative pain, associated risk factors, and their impact on prognosis; 5. Investigate the optimal perioperative transfusion strategies for allogeneic blood products based on causal relationships, develop predictive models, and validate them.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Min Yan, Doctor; Phone Number: 15888210247; Email: zryanmin@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cardiac surgery from May 1, 2026 to December 31, 2031

Description

Inclusion Criteria:

• Patients undergoing cardiac surgery from May 1, 2026 to December 31, 2031

Exclusion Criteria:

• Refusal to provide informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Procedure: Cardiac surgey; Cardiac surgey

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of major adverse cardiac and cerebrovascular events (MACCE)	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	Allogeneic red blood cells, plasma, platelets, and blood coagulation factors	30 days after surgery
Amount of Allogeneic Blood Products Transfused During the Perioperative Period	Allogeneic red blood cells, plasma, platelets, and blood coagulation factors	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of unplanned hospital readmission within 4 and 12 weeks after surgery	Unplanned hospital readmission	4 and 12 weeks after surgery
Incidence of perioperative myocardial infarction	Myocardial infarction	4, 12 weeks and 1years after surgery
Incidence of New-onset stroke	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	death	4, 12 weeks and 1years after surgery
Incidence of acute kidney injury	acute kidney injury was defined by guidelines of kindey disease：improving global outcomes（KIDGO）	7days after suegery
Incidence of infectious complications	Infectious complications include, but are not limited to, pneumonia, surgical site infection, etc.	4, 12 weeks and 1years after surgery
Length of hospital stay	Length of hospital stay	Through patients discharge, an average of 7 days after surgery
Hospitalization costs	Hospitalization costs	Through patients discharge, an average of 7 days after surgery
Quality of life scores	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	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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): June 25, 2026
• Primary Completion (Estimated): May 31, 2031
• Study Completion (Estimated): May 31, 2032

Study Registration Dates

• First Submitted: May 24, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Ischemia; Coronary Artery Disease; Coronary Disease; Heart Valve Diseases; Aortic Diseases
• Other Study ID Numbers: 2026-0345

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No