Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07662317

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Valve Heart Disease Aortic Diseases Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Coronary Heart Disease Heart Diseases Heart Valve Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

Location status: Recruiting

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Refusal to provide informed consent

Treatment and study plan

Cardiac surgey

Procedure

Cardiac surgey

Primary outcomes

  1. 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

  2. Incidence of Perioperative Transfusion of Allogeneic Blood Products

    Time frame: 30 days after surgery

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

  3. 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

Secondary outcomes

  1. Incidence of perioperative myocardial infarction

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

    Myocardial infarction

  2. Incidence of New-onset stroke

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

    New-onset stroke: new irreversible neurological impairment confirmed by radiological examination or autopsy showing a new cerebral lesion

  3. Incidence of death

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

    death

  4. Incidence of acute kidney injury

    Time frame: 7days after suegery

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

  5. Incidence of infectious complications

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

    Infectious complications include, but are not limited to, pneumonia, surgical site infection, etc.

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

    Time frame: 4 and 12 weeks after surgery

    Unplanned hospital readmission

  7. Length of hospital stay

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

    Length of hospital stay

  8. Hospitalization costs

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

    Hospitalization costs

  9. Quality of life scores

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

    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.

  10. Quality of life scores

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Min Yan, Doctor

CONTACT

[email protected]

15888210247

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Jun 23, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.