An observational study in Valve Heart Disease, Coronary Artery Disease and Coronary Heart Disease, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational
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.
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.
552 studies on the registry are indexed under Heart Valve Diseases; 162 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 300 across 226 observational studies indexed under Heart Valve Diseases.
Browse Heart Valve Diseases studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing cardiac surgery from May 1, 2026 to December 31, 2031
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Time frame: 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
Time frame: 30 days after surgery
Amount of Allogeneic Blood Products Transfused During the Perioperative Period
Allogeneic red blood cells, plasma, platelets, and blood coagulation factors
Time frame: 30 days after surgery
Incidence of perioperative myocardial infarction
Myocardial infarction
Time frame: 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
Time frame: 4, 12 weeks and 1years after surgery
Incidence of death
death
Time frame: 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)
Time frame: 7days after suegery
Incidence of infectious complications
Infectious complications include, but are not limited to, pneumonia, surgical site infection, etc.
Time frame: 4, 12 weeks and 1years after surgery
Incidence of unplanned hospital readmission within 4 and 12 weeks after surgery
Unplanned hospital readmission
Time frame: 4 and 12 weeks after surgery
Length of hospital stay
Length of hospital stay
Time frame: Through patients discharge, an average of 7 days after surgery
Hospitalization costs
Hospitalization costs
Time frame: 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.
Time frame: 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.
Time frame: at 4, 12 weeks and 1 years after surgery
Start is estimated for Jun 2026; primary completion for May 2031, 59 months later.
Of 95 non-industry observational studies under Heart Valve Diseases, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 212. This study's planned 59 months is below that.
Counting every sponsor, half of 115 studies reached it within 67 months; a quarter within 23 and three quarters within 212.
How these figures are worked out, and which studies are left out of them.
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Second Affiliated Hospital, School of Medicine, Zhejiang University →