Status:
NOT_YET_RECRUITING
Preoperative vs Postoperative Revascularization in Coronary Heart Disease Patients Undergoing Time-Sensitive Non-Cardiac Surgery (CHRONOS-PCI)
Lead Sponsor:
First Affiliated Hospital of Wenzhou Medical University
Conditions:
Coronary Artery Disease
Noncardiac Surgery
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
To compare the safety and efficacy of preoperative versus postoperative revascularization strategies in patients with coronary heart disease undergoing time-sensitive non-cardiac surgery.
Detailed Description
1. Study overview This study is a prospective, open-label, randomized, multicenter trial to evaluate the safety and efficacy of preoperative versus postoperative revascularization strategies in patien...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Diagnosis of coronary heart disease with non-emergent indication for PCI confirmed by coronary angiography：
- Non-ST-elevation acute coronary syndrome (NSTE-ACS) at low or intermediate ischemic risk
- Chronic coronary syndrome (CCS) with one of the following anatomical characteristics (see Appendix 1 for definition):
- Moderate or severe stenosis of the left main coronary artery
- Multivessel disease involving the ostium of the left anterior descending artery
- Three-vessel disease with ≥70% stenosis in each major epicardial vessel
- Indication for time-sensitive non-cardiac surgery
- Planned non-cardiac surgery under general anesthesia in the following surgical departments: thoracic surgery, gastrointestinal surgery, colorectal surgery, hepatobiliary and pancreatic surgery, or gynecology
- For patients with malignant tumors requiring time-sensitive surgery: written informed consent confirming understanding and acceptance that, if randomized to the "PCI-first" group, their tumor surgery will be delayed until 90±14 days after PCI, with acknowledgement of potential risks (e.g., tumor progression, change in resectability)
- Ability to understand the study requirements and sign written informed consent in the language provided by the research team
Exclusion
- Age \>80 years
- Severe thrombocytopenia (platelet count \<50×10⁹/L)
- Cardiogenic shock, severe heart failure (NYHA class IV, Killip class IV, or LVEF ≤35%), malignant arrhythmias (including cardiac arrest, asystole, ventricular fibrillation, or sustained ventricular tachycardia), or other life-threatening conditions requiring resuscitation
- Moderate-to-severe valvular heart disease, high-grade atrioventricular block, or other severe cardiac/pulmonary dysfunction incompatible with the planned surgery
- Planned surgery with extremely high bleeding risk (e.g., intracranial surgery, spinal surgery, retinal surgery)
- Patients with malignant tumors undergoing non-palliative surgery who are in poor general condition, defined as meeting any of the following:
- Karnofsky performance score \<60
- Eastern Cooperative Oncology Group (ECOG) performance status \>2
- Disease stage beyond surgical indications or estimated life expectancy \<1 year
- Patients requiring emergency or urgent surgery due to critical illness
- Severe renal dysfunction: serum creatinine \>442 μmol/L, GFR ≤30 mL/min/1.73 m², or currently on renal replacement therapy
- Severe hepatic dysfunction: Child-Pugh class C or higher
- Severe uncontrolled systemic infection
- Advanced dementia with significant decline in quality of life requiring full-time care and support
- Systemic thromboembolic disease (e.g., pulmonary embolism) making surgery unsuitable
- Women who are pregnant, breastfeeding, or planning pregnancy during the study period
- Severe, uncontrolled comorbid conditions continuously impairing physiological or psychological function
- Participation in another clinical study within 3 months prior to enrollment
- Any condition judged by the investigator to interfere with participation or study conduct
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT07175870
Start Date
October 1 2025
End Date
August 1 2029
Last Update
September 16 2025
Active Locations (1)
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1
the First Affiliated Hospitalof Wenzhou Medical University
Wenzhou, Zhejiang, China