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

NCT07662317 | Recruiting

• 1 other identifier: 2026-0345
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Valve Heart Disease; Coronary Artery Disease; Coronary Heart Disease; Aortic Diseases

Outcome Measures

Primary Outcomes (3)

• 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

  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

  30 days after surgery

• Amount of Allogeneic Blood Products Transfused During the Perioperative Period

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

  30 days after surgery

Secondary Outcomes (10)

• Incidence of perioperative myocardial infarction

  4, 12 weeks and 1years after surgery

• Incidence of New-onset stroke

  4, 12 weeks and 1years after surgery

• Incidence of death

  4, 12 weeks and 1years after surgery

• Incidence of acute kidney injury

  7days after suegery

• Incidence of infectious complications

  4, 12 weeks and 1years after surgery

Study Arms (1)

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

Cardiac surgey PROCEDURE

Cardiac surgey

Perioperative Observation Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Refusal to provide informed consent

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

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

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases; Coronary Artery Disease; Coronary Disease; Aortic Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Min Yan, Doctor

CONTACT

15888210247; zryanmin@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 23, 2026
• Study Start: June 25, 2026
• Primary Completion (Estimated): May 31, 2031
• Study Completion (Estimated): May 31, 2032
• Last Updated: June 23, 2026

Record last verified: 2026-04

Locations

CN (1)