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NCT07175870Not yet recruiting

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

Comparison of Clinical Outcomes Between Preoperative and Postoperative Revascularization in Coronary Heart Disease Patients With Time-Sensitive NOn-Cardiac Surgery: A Multicenter Pragmatic Randomized Controlled Trial (CHRONOS-PCI)

Source: ClinicalTrials.gov · Last updated 16 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
140 (estimated)
First submitted
7 Sept 2025
Start date
Oct 2025
Primary completion date
Aug 2029
Lead sponsor
First Affiliated Hospital of Wenzhou Medical University
NCT number
NCT07175870

What you commit to

  • Study type: Interventional
  • Planned participants: 140
  • From Oct 2025 to the primary completion date, Aug 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participation in another clinical study within 3 months prior to enrollment

Other illness

  • 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 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
  • Severe, uncontrolled comorbid conditions continuously impairing physiological or psychological function
  • Any condition judged by the investigator to interfere with participation or study conduct

Lab values

  • 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
  • Severe renal dysfunction: serum creatinine \>442 μmol/L, GFR ≤30 mL/min/1.73 m², or currently on renal replacement therapy

Age

  • Age \>80 years

Other

  • Severe hepatic dysfunction: Child-Pugh class C or higher
  • Women who are pregnant, breastfeeding, or planning pregnancy during the study period

Who the study is looking for

  • 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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
the First Affiliated Hospitalof Wenzhou Medical University
Coordinator of this site? Confirm its status
WenzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.