Coronary Artery DiseaseCHRONOS-PCINCT07175870
Preoperative vs Postoperative Revascularization in Coronary Heart Disease Patients Undergoing Time-Sensitive Non-Cardiac Surgery (CHRONOS-PCI)
A study testing Non-cardiac surgery followed by postoperative PCI and Preoperative PCI followed by delayed non-cardiac surgery ~3 months later in people with Coronary Artery Disease and Noncardiac Surgery, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Noncardiac Surgery
- What is being tested?
- Non-cardiac surgery followed by postoperative PCI and Preoperative PCI followed by delayed non-cardiac surgery ~3 months later
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- Oct 2025to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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:
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the First Affiliated Hospitalof Wenzhou Medical University
Wenzhou, Zhejiang
Huiqing Xu, 0577-55578055, wyyyclinical@126.com
About this study
Official title: 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)
To compare the safety and efficacy of preoperative versus postoperative revascularization strategies in patients with coronary heart disease undergoing time-sensitive non-cardiac surgery.
Read the detailed description
- 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 patients with coronary heart disease undergoing time-sensitive non-cardiac surgery. The primary hypothesis is that the postoperative (surgery-first) revascularization strategy will show a non-inferior rate of major adverse cardiovascular events (MACE) at 180 days after randomization compared with the preoperative (revascularization-first) strategy.
- Study population and sample size calculation Based on previous data, the 180-day incidence of MACE was approximately 5.5% in patients undergoing postoperative revascularization and 5.7% in those undergoing preoperative revascularization. Using a non-inferiority margin (delta) of 4%, a two-sided type I error rate (α) of 0.05, and a power of 78%, a total of 140 patients (70 in each group) will be enrolled. An attrition rate of 10% was considered.
- Primary endpoint: MACE at 180 days after randomization, defined as a composite of all-cause death, myocardial infarction, and any repeat revascularization.
- Design: Non-inferiority, delta = 4%.
- Sampling ratio: 1:1 (surgery-first vs. revascularization-first).
- Type I error (α): Two-sided 0.05.
- Accrual time: 3 years.
- Total time: 3.5 years (3 years accrual + 6 months follow-up).
- Assumption: MACE 5.5% vs. 5.7% in surgery-first and revascularization-first groups, respectively.
- Statistical power (1-β): 78%.
- Primary statistical method: Farrington-Manning non-inferiority test for binary outcomes.
- Potential withdrawal rates: 10%.
- Stratification in randomization: Randomization will be stratified according to (1) the estimated cardiovascular risk of the non-cardiac surgery and (2) the bleeding risk of the surgery.
- Research materials and treatment strategies
- Surgery-first group: Patients will undergo the time-sensitive non-cardiac surgery first. Coronary revascularization (PCI) will be performed after surgery.
- Revascularization-first group: Patients will undergo coronary revascularization (PCI) prior to the non-cardiac surgery, according to guideline-based recommendations and operator judgment.
- Conditions
- Coronary Artery Disease, Noncardiac Surgery
- Being tested
- Non-cardiac surgery followed by postoperative PCI, Preoperative PCI followed by delayed non-cardiac surgery ~3 months later
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-cardiac surgery followed by postoperative PCIProcedure or 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 laterProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Non-cardiac surgery followed by postoperative PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events (MACE)
Composite of all-cause death, myocardial infarction, or repeat revascularization
Measured: 180 days after the first invasive procedure (non-cardiac surgery or PCI)
Secondary outcomes (12)
Major Bleeding
Major bleeding defined as Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding.
Measured: 180 days after the first invasive procedure (non-cardiac surgery or PCI)
All-Cause Mortality
Death from any cause within 180 days after the first invasive procedure (non-cardiac surgery or PCI)
Measured: 180 days after the first invasive procedure (non-cardiac surgery or PCI)
Myocardial Infarction
Incidence of myocardial infarction defined according to the Fourth Universal Definition
Measured: 180 days after the first invasive procedure (non-cardiac surgery or PCI)
Repeat Coronary Revascularization
Need for repeat PCI of target or non-target coronary arteries
Measured: 180 days after the first invasive procedure (non-cardiac surgery or PCI)
Stroke or Transient Ischemic Attack (TIA)
Incidence of ischemic stroke or TIA confirmed by imaging and neurological evaluation.
Measured: 180 days after the first invasive procedure (non-cardiac surgery or PCI)
New-Onset Acute Heart Failure
Acute onset of heart failure symptoms (e.g., dyspnea, edema, fatigue, palpitations) with clinical signs (including but not limited to displaced apical impulse, cardiac murmur, pulmonary rales, peripheral edema, hepatomegaly) and progressive elevation of BNP or NT-proBNP. Patients must require urgent treatment with intravenous diuretics and/or inotropes.
Measured: 180 days after the first invasive procedure (non-cardiac surgery or PCI)
Myocardial Injury After Non-Cardiac Surgery (MINS)
For patients with normal preoperative cTnT: elevation of cTnT within 72 hours after surgery, with at least one value above the 99th percentile URL of the assay, showing a rise/fall pattern suggestive of acute injury; For patients with elevated preoperative cTnT: postoperative increase ≥20% or absolute increase ≥14 ng/L above baseline, or ≥5 ng/L increase above previous concentration, with a peak value >20 ng/L, consistent with acute myocardial injury.
Measured: 72 hours after non-cardiac surgery
Length of Hospital Stay
Total hospital stay during the study period, including intensive care unit stay, calculated from admission to discharge for the index hospitalization and any subsequent readmissions.
Measured: 180 days after the first invasive procedure (non-cardiac surgery or PCI)
Duke Activity Status Index (DASI)
Comparison of DASI scores at baseline and at 6 months. The score ranges from 0 to 58.2, with higher scores indicating better functional status.
Measured: Baseline and 180±30 days after the first invasive procedure
Fried Frailty Index
Comparison of Fried scores at baseline and at 6 months. Scoring criteria: 1 point is assigned for each criterion met; a total score ≥3 indicates frailty; 1-2 points indicate a pre-frail state; and 0 points indicate a robust (non-frail) health status.
Measured: Baseline and 180±30 days after the first invasive procedure
New York Heart Association (NYHA) classification
The New York Heart Association (NYHA) classification is a widely used system for grading the severity of heart failure symptoms, ranging from Class I (no limitation of physical activity) to Class IV (symptoms present even at rest, with severe limitations). In this study, we compared the distribution of NYHA classes at baseline and at the 6-month follow-up to evaluate changes in patients' functional status over time.
Measured: Baseline and 180±30 days after the first invasive procedure
Patient Health Questionnaire-9 (PHQ-9) depression score.
The total score of the PHQ-9 can be used to assess the severity of depressive symptoms: 0-4 indicates no depression, 5-9 mild, 10-14 moderate, and ≥15 severe. Comparison of PHQ-9 scores at baseline and at 6 months reflects either the progression or improvement of depressive symptoms in patients.
Measured: Baseline and 180±30 days after the first invasive procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175870
- Sponsor's protocol ID
- KY2025-304
- Acronym
- CHRONOS-PCI
- Status last verified
- Sep 2025
- First submitted
- 7 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07175870
- Acronym / sponsor ID
- CHRONOS-PCI / KY2025-304
- Conditions
- Coronary Artery Disease, Noncardiac Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 patients with coronary heart disease undergoing time-sensitive non-cardiac surgery. The primary hypothesis is that the postoperative (surgery-first) revascularization strategy will show a non-inferior rate of major adverse cardiovascular events (MACE) at 180 days after randomization compared with the preoperative (revascularization-first) strategy.
- Study population and sample size calculation Based on previous data, the 180-day incidence of MACE was approximately 5.5% in patients undergoing postoperative revascularization and 5.7% in those undergoing preoperative revascularization. Using a non-inferiority margin (delta) of 4%, a two-sided type I error rate (α) of 0.05, and a power of 78%, a total of 140 patients (70 in each group) will be enrolled. An attrition rate of 10% was considered.
- Primary endpoint: MACE at 180 days after randomization, defined as a composite of all-cause death, myocardial infarction, and any repeat revascularization.
- Design: Non-inferiority, delta = 4%.
- Sampling ratio: 1:1 (surgery-first vs. revascularization-first).
- Type I error (α): Two-sided 0.05.
- Accrual time: 3 years.
- Total time: 3.5 years (3 years accrual + 6 months follow-up).
- Assumption: MACE 5.5% vs. 5.7% in surgery-first and revascularization-first groups, respectively.
- Statistical power (1-β): 78%.
- Primary statistical method: Farrington-Manning non-inferiority test for binary outcomes.
- Potential withdrawal rates: 10%.
- Stratification in randomization: Randomization will be stratified according to (1) the estimated cardiovascular risk of the non-cardiac surgery and (2) the bleeding risk of the surgery.
- Research materials and treatment strategies
- Surgery-first group: Patients will undergo the time-sensitive non-cardiac surgery first. Coronary revascularization (PCI) will be performed after surgery.
- Revascularization-first group: Patients will undergo coronary revascularization (PCI) prior to the non-cardiac surgery, according to guideline-based recommendations and operator judgment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery-First Strategy (Postoperative Revascularization) | Experimental | Procedure: Preoperative PCI followed by delayed non-cardiac surgery ~3 months laterPatients 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. |
| PCI-First Strategy (Preoperative PCI with Delayed Surgery) | Active comparator | Procedure: Non-cardiac surgery followed by postoperative PCIPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years
- Diagnosis of coronary heart disease with non-emergent indication for PCI confirmed by coronary angiography：
- 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)
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-cardiac surgery followed by postoperative PCIPatients 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. | Procedure or surgery | PCI-First Strategy (Preoperative PCI with Delayed Surgery) |
| Preoperative PCI followed by delayed non-cardiac surgery ~3 months laterPatients 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. | Procedure or surgery | Surgery-First Strategy (Postoperative Revascularization) |
Primary outcome
Major Adverse Cardiovascular Events (MACE)
Time frame: 180 days after the first invasive procedure (non-cardiac surgery or PCI)
Composite of all-cause death, myocardial infarction, or repeat revascularization
12 secondary outcomes
Major Bleeding
Time frame: 180 days after the first invasive procedure (non-cardiac surgery or PCI)
All-Cause Mortality
Time frame: 180 days after the first invasive procedure (non-cardiac surgery or PCI)
Myocardial Infarction
Time frame: 180 days after the first invasive procedure (non-cardiac surgery or PCI)
Repeat Coronary Revascularization
Time frame: 180 days after the first invasive procedure (non-cardiac surgery or PCI)
Stroke or Transient Ischemic Attack (TIA)
Time frame: 180 days after the first invasive procedure (non-cardiac surgery or PCI)
New-Onset Acute Heart Failure
Time frame: 180 days after the first invasive procedure (non-cardiac surgery or PCI)
Myocardial Injury After Non-Cardiac Surgery (MINS)
Time frame: 72 hours after non-cardiac surgery
Length of Hospital Stay
Time frame: 180 days after the first invasive procedure (non-cardiac surgery or PCI)
Duke Activity Status Index (DASI)
Time frame: Baseline and 180±30 days after the first invasive procedure
Fried Frailty Index
Time frame: Baseline and 180±30 days after the first invasive procedure
New York Heart Association (NYHA) classification
Time frame: Baseline and 180±30 days after the first invasive procedure
Patient Health Questionnaire-9 (PHQ-9) depression score.
Time frame: Baseline and 180±30 days after the first invasive procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-cardiac surgery followed by postoperative PCI and Preoperative PCI followed by delayed non-cardiac surgery ~3 months later in people with Coronary Artery Disease and Noncardiac Surgery, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Zhou (+86 13968801939, wyzh66@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (MACE) (time frame: 180 days after the first invasive procedure (non-cardiac surgery or PCI)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.