Valve Heart DiseaseNCT07662317
Construction of a Prospective Cohort Database for the Perioperative Period of Cardiac Surgery
An observational study of Valve Heart Disease and Coronary Artery Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Valve Heart Disease, Coronary Artery Disease, Coronary Heart Disease
- What is being tested?
- Cardiac surgey
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2026to 31 May 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing cardiac surgery from May 1, 2026 to December 31, 2031
Who may be able to join
- Patients undergoing cardiac surgery from May 1, 2026 to December 31, 2031
Who cannot join
- Refusal to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang
About this study
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.
Read the detailed description
- 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.
- Being tested
- Cardiac surgey
- Medical subject headings
- Heart Valve Diseases, Coronary Artery Disease, Coronary Disease, Aortic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgeyProcedure or surgery
Cardiac surgey
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Procedure: Cardiac surgey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 30 days after surgery
Amount of Allogeneic Blood Products Transfused During the Perioperative Period
Allogeneic red blood cells, plasma, platelets, and blood coagulation factors
Measured: 30 days after surgery
Secondary outcomes (10)
Incidence of perioperative myocardial infarction
Myocardial infarction
Measured: 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
Measured: 4, 12 weeks and 1years after surgery
Incidence of death
death
Measured: 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）
Measured: 7days after suegery
Incidence of infectious complications
Infectious complications include, but are not limited to, pneumonia, surgical site infection, etc.
Measured: 4, 12 weeks and 1years after surgery
Incidence of unplanned hospital readmission within 4 and 12 weeks after surgery
Unplanned hospital readmission
Measured: 4 and 12 weeks after surgery
Length of hospital stay
Length of hospital stay
Measured: Through patients discharge, an average of 7 days after surgery
Hospitalization costs
Hospitalization costs
Measured: 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.
Measured: 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.
Measured: at 4, 12 weeks and 1 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start25 Jun 2026 (estimated)
- Primary completion31 May 2031 (estimated)
- Study completion31 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valve Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662317
- Sponsor's protocol ID
- 2026-0345
- Status last verified
- Apr 2026
- First submitted
- 24 May 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Prospective Cohort Database for the Perioperative Period of Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07662317
- Acronym / sponsor ID
- 2026-0345
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 25 Jun 2026 (estimated)
- Primary completion
- 31 May 2031 (estimated)
- Study completion
- 31 May 2032 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perioperative Observation Group | – | Procedure: Cardiac surgeyPatients 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing cardiac surgery from May 1, 2026 to December 31, 2031
Key inclusion criteria (1 listed)
- Patients undergoing cardiac surgery from May 1, 2026 to December 31, 2031
Key exclusion criteria (1 listed)
- Refusal to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac surgeyCardiac surgey | Procedure or surgery | Perioperative Observation Group |
Primary outcome
Incidence of major adverse cardiac and cerebrovascular events (MACCE)
Time frame: 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
Incidence of Perioperative Transfusion of Allogeneic Blood Products
Time frame: 30 days after surgery
Allogeneic red blood cells, plasma, platelets, and blood coagulation factors
Amount of Allogeneic Blood Products Transfused During the Perioperative Period
Time frame: 30 days after surgery
Allogeneic red blood cells, plasma, platelets, and blood coagulation factors
10 secondary outcomes
Incidence of perioperative myocardial infarction
Time frame: 4, 12 weeks and 1years after surgery
Incidence of New-onset stroke
Time frame: 4, 12 weeks and 1years after surgery
Incidence of death
Time frame: 4, 12 weeks and 1years after surgery
Incidence of acute kidney injury
Time frame: 7days after suegery
Incidence of infectious complications
Time frame: 4, 12 weeks and 1years after surgery
Incidence of unplanned hospital readmission within 4 and 12 weeks after surgery
Time frame: 4 and 12 weeks after surgery
Length of hospital stay
Time frame: Through patients discharge, an average of 7 days after surgery
Hospitalization costs
Time frame: Through patients discharge, an average of 7 days after surgery
Quality of life scores
Time frame: at 4, 12 weeks and 1 years after surgery
Quality of life scores
Time frame: at 4, 12 weeks and 1 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valve Heart Disease and Coronary Artery Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Yan, Doctor (15888210247, zryanmin@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major adverse cardiac and cerebrovascular events (MACCE) (time frame: 4, 12 weeks and 1years after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.