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

ConditionsCoronary Artery DiseaseNoncardiac Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFirst Affiliated Hospital of Wenzhou Medical University

About this trial

To compare the safety and efficacy of preoperative versus postoperative revascularization strategies in patients with coronary heart disease undergoing time-sensitive non-cardiac surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Moderate or severe stenosis of the left main coronary artery

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Non-cardiac surgery followed by postoperative PCI

    Procedure/Surgery

    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.

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

    Procedure/Surgery

    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.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Surgery-First Strategy (Postoperative Revascularization)Experimental treatment 1 intervention
Group B: PCI-First Strategy (Preoperative PCI with Delayed Surgery)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Major Adverse Cardiovascular Events (MACE)

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

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

Secondary outcomes

1

Major Bleeding

Major bleeding defined as Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding.

Time frame
180 days after the first invasive procedure (non-cardiac surgery or PCI)
2

All-Cause Mortality

Death from any cause within 180 days after the first invasive procedure (non-cardiac surgery or PCI)

Time frame
180 days after the first invasive procedure (non-cardiac surgery or PCI)
3

Myocardial Infarction

Incidence of myocardial infarction defined according to the Fourth Universal Definition

Time frame
180 days after the first invasive procedure (non-cardiac surgery or PCI)
4

Repeat Coronary Revascularization

Need for repeat PCI of target or non-target coronary arteries

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Wenzhou Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: