Preoperative vs Postoperative Revascularization in Coronary Heart Disease Patients Undergoing Time-Sensitive Non-Cardiac Surgery (CHRONOS-PCI)

NCT07175870 | Not Yet Recruiting DMC

• 1 other identifier: KY2025-304
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Noncardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiovascular Events (MACE)

  Composite of all-cause death, myocardial infarction, or repeat revascularization

  180 days after the first invasive procedure (non-cardiac surgery or PCI)

Secondary Outcomes (12)

• Major Bleeding

  180 days after the first invasive procedure (non-cardiac surgery or PCI)

• All-Cause Mortality

  180 days after the first invasive procedure (non-cardiac surgery or PCI)

• Myocardial Infarction

  180 days after the first invasive procedure (non-cardiac surgery or PCI)

• Repeat Coronary Revascularization

  180 days after the first invasive procedure (non-cardiac surgery or PCI)

• Stroke or Transient Ischemic Attack (TIA)

  180 days after the first invasive procedure (non-cardiac surgery or PCI)

Study Arms (2)

Surgery-First Strategy (Postoperative Revascularization)

EXPERIMENTAL

Patients with coronary heart disease scheduled for time-sensitive non-cardiac surgery. The surgery will be performed in a hybrid operating room. If an acute coronary event occurs intraoperatively, standby PCI will be performed immediately. Elective PCI may also be performed postoperatively if clinically indicated.

Procedure: Preoperative PCI followed by delayed non-cardiac surgery ~3 months later

PCI-First Strategy (Preoperative PCI with Delayed Surgery)

ACTIVE COMPARATOR

Patients with coronary heart disease scheduled for time-sensitive non-cardiac surgery. Participants will undergo PCI first, followed by non-cardiac surgery approximately 3 months later, according to current guideline recommendations for elective surgery after PCI.

Procedure: Non-cardiac surgery followed by postoperative PCI

Interventions

Non-cardiac surgery followed by postoperative PCI PROCEDURE

Patients undergo the planned time-sensitive non-cardiac surgery first in a hybrid operating room, with PCI standby available in case of an intraoperative acute coronary event. If such an event occurs, immediate PCI will be performed. Additional PCI will be performed postoperatively if clinically indicated.

PCI-First Strategy (Preoperative PCI with Delayed Surgery)

Preoperative PCI followed by delayed non-cardiac surgery ~3 months later PROCEDURE

Patients undergo PCI first. The planned non-cardiac surgery will then be performed approximately 3 months after PCI, in accordance with current guideline recommendations for the timing of non-cardiac surgery following PCI.

Surgery-First Strategy (Postoperative Revascularization)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

the First Affiliated Hospitalof Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hao Zhou

CONTACT

+86 13968801939; wyzh66@126.com

KEN LIN

CONTACT

+86 18967760021; linken1999@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: September 16, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

CN (1)