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Mixed Cohort Study on the Relationship Between Preoperative PCI Status and Outcomes of Elective Noncardiac Surgery in Patients with Stable Coronary Artery Disease: Prospective Assessment of Exercise Tolerance and Retrospective Real-World Data

Mixed Cohort Study on the Relationship Between Preoperative PCI Status and Outcomes of Elective Noncardiac Surgery in Patients with Stable Coronary Artery Disease: Prospective Assessment of Exercise Tolerance and Retrospective Real-World Data

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500115564
Enrollment
Unknown
Registered
2025-12-29
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Adverse Cardiovascular and Cerebrovascular Events

Interventions

PCI group (patients who underwent PCI within 1 year before elective noncardiac surgery)— prospective:None
Non-PCI group (patients who did not undergo PCI within 1 year before elective noncardiac surgery)— prospective:None
PCI group (patients who underwent PCI within 1 year before elective noncardiac surgery)—retrospective:None
Non-PCI group (patients who did not undergo PCI within 1 year before elective noncardiac surgery)— retrospective:None

Sponsors

Affiliated Hospital of Fujian Medical University, Xiehe Branch
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Patients aged >=18 years of either sex who are scheduled to undergo elective noncardiac surgery at our hospital; (2) Patients with stable coronary artery disease who have a clear guideline-based indication for PCI and no evidence of acute coronary syndrome (ACS); (3) In the retrospective cohort, patients are grouped according to whether they are within 12 months after PCI: those within 12 months are assigned to the PCI group, and those beyond 12 months or without prior PCI are assigned to the non-PCI group; (4) In the prospective cohort, grouping is based on the patients’ actual preoperative clinical management. The decision to perform PCI is made independently by cardiologists in accordance with current guidelines and implemented after full informed consent is obtained from the patient and family members. Investigators assign patients to the PCI or non-PCI group only after the treatment strategy has been finalized; the research team does not participate in treatment decision-making; (5) Patients and their family members are informed about the study and provide written informed consent for the prospective cohort; informed consent is waived for the retrospective cohort; (6) Complete preoperative evaluation data (including ECG, transthoracic echocardiography, coronary CTA, coronary angiography, etc.) and complete follow-up data for at least 12 months are available.

Exclusion criteria

Exclusion criteria: (1) Acute coronary syndrome, including unstable angina, non–ST-segment elevation myocardial infarction (NSTEMI), or ST-segment elevation myocardial infarction (STEMI); (2) Chest pain clearly attributable to non–coronary artery disease causes, such as aortic dissection, pulmonary embolism, or pericarditis; (3) Prior coronary artery bypass grafting (CABG); (4) Undergoing cardiac or cardiac-related surgery; (5) Recent (e.g., within the past 3 months) acute heart failure or severe arrhythmia; (6) Concomitant severe structural heart disease, such as severe valvular disease; (7) Severe cognitive impairment or psychiatric disorders that preclude cooperation with treatment or follow-up; (8) Patients without a guideline-based indication for PCI on clinical evaluation, but who or whose legally authorized representatives strongly request PCI.

Design outcomes

Primary

MeasureTime frame
Major Adverse Cardiovascular and Cerebrovascular Events;All-cause mortality;

Secondary

MeasureTime frame
Myocardial infarction; stroke; repeat revascularization (PCI or CABG); cardiopulmonary resuscitation; electrical cardioversion required for severe arrhythmias.;Stair-climbing test parameters (stair-climbing height, total duration, number of rest stops) and heart rate variability (HRV) indices;QFR-based coronary physiological parameters (measured in a subset of patients);Hemodynamic parameters: heart rate (HR), blood pressure (BP), and oxygen saturation (SpO?).;

Countries

China

Contacts

Public ContactLai Zhongmeng

Affiliated Hospital of Fujian Medical University, Xiehe Branch

zl7mg@fjmu.edu.cn+86 133 9500 0771

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026