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Construction of a Prospective Cohort Database for the Perioperative Period of Cardiac Surgery

Construction of a Prospective Cohort Database for the Perioperative Period of Cardiac Surgery

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07662317
Enrollment
10000
Registered
2026-06-23
Start date
2026-06-25
Completion date
2032-05-31
Last updated
2026-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Diseases, Coronary Artery Disease, Coronary Heart Disease, Valve Heart Disease

Brief summary

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.

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.

Interventions

PROCEDURECardiac surgey

Cardiac surgey

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Refusal to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
Incidence of major adverse cardiac and cerebrovascular events (MACCE)4, 12 weeks and 1years after surgeryMyocardial infarction; New-onset stroke: new irreversible neurological impairment confirmed by radiological examination or autopsy showing a new cerebral lesion; Death
Incidence of Perioperative Transfusion of Allogeneic Blood Products30 days after surgeryAllogeneic red blood cells, plasma, platelets, and blood coagulation factors
Amount of Allogeneic Blood Products Transfused During the Perioperative Period30 days after surgeryAllogeneic red blood cells, plasma, platelets, and blood coagulation factors

Secondary

MeasureTime frameDescription
Incidence of perioperative myocardial infarction4, 12 weeks and 1years after surgeryMyocardial infarction
Incidence of New-onset stroke4, 12 weeks and 1years after surgeryNew-onset stroke: new irreversible neurological impairment confirmed by radiological examination or autopsy showing a new cerebral lesion
Incidence of death4, 12 weeks and 1years after surgerydeath
Incidence of acute kidney injury7days after suegeryacute kidney injury was defined by guidelines of kindey disease:improving global outcomes(KIDGO)
Incidence of infectious complications4, 12 weeks and 1years after surgeryInfectious complications include, but are not limited to, pneumonia, surgical site infection, etc.
Incidence of unplanned hospital readmission within 4 and 12 weeks after surgery4 and 12 weeks after surgeryUnplanned hospital readmission
Length of hospital stayThrough patients discharge, an average of 7 days after surgeryLength of hospital stay
Hospitalization costsThrough patients discharge, an average of 7 days after surgeryHospitalization costs
Quality of life scoresat 4, 12 weeks and 1 years after surgeryQuality 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.

Countries

China

Contacts

CONTACTMin Yan, Doctor
zryanmin@zju.edu.cn15888210247

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 24, 2026