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RecruitingNCT07662317Updated Jun 23, 2026

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

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Valve Heart Disease
  • Coronary Artery Disease
  • Coronary Heart Disease
  • Aortic Diseases
03

In context

Heart Valve Diseases

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Refusal to provide
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • ProcedureCardiac surgey

    Cardiac surgey

06

What researchers measure

Primary outcomes

  1. 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

  2. Incidence of Perioperative Transfusion of Allogeneic Blood Products

    Allogeneic red blood cells, plasma, platelets, and blood coagulation factors

    Time frame: 30 days after surgery

  3. 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

Secondary outcomes

  1. Incidence of perioperative myocardial infarction

    Myocardial infarction

    Time frame: 4, 12 weeks and 1years after surgery

  2. 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

  3. Incidence of death

    death

    Time frame: 4, 12 weeks and 1years after surgery

  4. Incidence of acute kidney injury

    acute kidney injury was defined by guidelines of kindey disease:improving global outcomes(KIDGO)

    Time frame: 7days after suegery

  5. 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

  6. Incidence of unplanned hospital readmission within 4 and 12 weeks after surgery

    Unplanned hospital readmission

    Time frame: 4 and 12 weeks after surgery

  7. Length of hospital stay

    Length of hospital stay

    Time frame: Through patients discharge, an average of 7 days after surgery

  8. Hospitalization costs

    Hospitalization costs

    Time frame: Through patients discharge, an average of 7 days after surgery

  9. 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

  10. 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

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
May 24, 2026
First posted
Jun 23, 2026
StartEst.
Jun 25, 2026
Primary completionEst.
May 31, 2031
CompletionEst.
May 31, 2032
Last update
Jun 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07662317
Responsible party
Sponsor
First posted
Jun 23, 2026
Start date
Jun 25, 2026 (estimated)
Primary completion
May 31, 2031 (estimated)
Completion
May 31, 2032 (estimated)
Last update
Jun 23, 2026

Study contacts

Min Yan, Doctor
Contact
zryanmin@zju.edu.cn
15888210247

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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