Myocardial Injury After Non-Cardiac SurgeryNCT06895798
Differential Impact of Pringle and Portal Vein Occlusion on Myocardial Injury After Non-Cardiac Surgeries.
An observational study of Myocardial Injury After Non-Cardiac Surgery and Ischemia Reperfusion Injury, run by Beijing Tsinghua Chang Gung Hospital at 2 sites in China.
Trial summary
This study aims to investigate the impact of hepatic ischemia-reperfusion injury (HIRI) on the incidence of myocardial injury after non-cardiac surgery (MINS) and explore the potential underlying mechanisms. A bidirectional cohort study will be conducted, enrolling patients scheduled for major hepato-biliary surgery. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Myocardial Injury After Non-Cardiac Surgery, Ischemia Reperfusion Injury
- How many people
- 1,286 participants
- Where
- 2 sitesChina
- Study dates
- 7 Mar 2025to 15 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: As of February 2024, patients ≥ 65 years old, or ≥ 45 years old with cardiovascular risk factors (especially known cardiovascular disease), who have undergone or are scheduled to undergo elective major hepatopancreatobiliary surgery under general anesthesia are being recruited/enrolled.
Who may be able to join
- Age ≥ 65 years, or ≥ 45 years with cardiovascular risk factors (especially known cardiovascular disease).
- Undergoing elective major hepatopancreatobiliary surgery under general anesthesia.
- ASA physical status II-III.
- Provide written informed consent to participate in the study (applicable to the prospective cohort).
Who cannot join
- Emergency surgery
- Preoperative diagnosis of myocardial infarction or unstable angina
- Severe hepatic insufficiency (Child-Pugh class C)
- Concomitant severe organ dysfunction (e.g., renal failure, respiratory failure)
- Concomitant active infectious disease
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine，Tsinghua University
Beijing, Beijing Municipality, 102218
Peking University International Hospital
Beijing
About this study
Official title: Differential Impact of Pringle Occlusion vs. Portal Vein Occlusion-Induced Liver Ischaemia-Reperfusion Injury on Myocardial Injury Following Noncardiac Surgeries.
This study aims to investigate the impact of hepatic ischemia-reperfusion injury (HIRI) on the incidence of myocardial injury after non-cardiac surgery (MINS) and explore the potential underlying mechanisms. A bidirectional cohort study will be conducted, enrolling patients scheduled for major hepato-biliary surgery. Clinical data, perioperative parameters, and postoperative follow-up data will be systematically collected. The incidence of MINS between patients undergoing Pringle occlusion and portal vein occlusion will be compared, and a multivariate analysis will be performed to identify independent risk factors for MINS, providing a basis for early recognition and prevention of MINS.
Read the detailed description
This observational cohort study consists of both retrospective and prospective components. The study population includes patients undergoing major hepato-biliary surgery (defined as operative time > 4 hours and postoperative ICU admission) who are either ≥ 65 years old or ≥ 45 years old with cardiovascular risk factors (especially known cardiovascular disease). The exposed group (Pringle group) consists of patients who experience liver ischemia-reperfusion injury due to Pringle occlusion during surgery. The control group (Portal vein group) consists of patients who experience liver ischemia-reperfusion injury due to Portal vein occlusion. The primary outcome is the incidence of MINS (myocardial injury after non-cardiac surgery) within 3 days postoperatively. Secondary outcomes include postoperative length of hospital stay, incidence of complications within 30 days postoperatively, and 1-year survival rate. Finally, liver and blood samples will be collected from a subset of patients in the prospective LIRI group for pathophysiological mechanism investigation.
- Keywords
- liver ischemia reperfusion injury, Myocardial Injury After Non-Cardiac Surgery, Major Hepato-Biliary Surgery, Pringle occlusion, Portal vein occlusion
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Portal vein | The patient will experience and only experience portal vein occlusion during the surgery. | |
| Pringle | The patient will experience Pringle occlusion during the surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial injury after non-cardiac surgery (MINS)
MINS, a high-sensitivity troponin T (hs-cTnT) of 20 to <65 ng/L with an absolute change of at least 5 ng/L
Measured: Within 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start7 Mar 2025
- Primary completion15 Jun 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial Injury After Non-Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhifeng Gao, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895798
- Sponsor's protocol ID
- 25045-4-02-1
- Status last verified
- Jun 2026
- First submitted
- 22 Mar 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Duan Y, Zhang Z, Wei J, Wen Q, Ding L, Wang Y, Lu Q, Gao Z. Selective portal vein occlusion and myocardial injury after major hepatobiliary surgery: a propensity-weighted cohort study. Sci Rep. 2026 Jul 20. doi: 10.1038/s41598-026-63106-w. Online ahead of print.
PubMed 42477388
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Impact of Pringle Occlusion vs. Portal Vein Occlusion-Induced Liver Ischaemia-Reperfusion Injury on Myocardial Injury Following Noncardiac Surgeries.
- ClinicalTrials.gov ID
- NCT06895798
- Acronym / sponsor ID
- 25045-4-02-1
- Keywords
- liver ischemia reperfusion injury, Myocardial Injury After Non-Cardiac Surgery, Major Hepato-Biliary Surgery, Pringle occlusion, Portal vein occlusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,286 participants (actual)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 26 Mar 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.
This study aims to investigate the impact of hepatic ischemia-reperfusion injury (HIRI) on the incidence of myocardial injury after non-cardiac surgery (MINS) and explore the potential underlying mechanisms. A bidirectional cohort study will be conducted, enrolling patients scheduled for major hepato-biliary surgery. Clinical data, perioperative parameters, and postoperative follow-up data will be systematically collected. The incidence of MINS between patients undergoing Pringle occlusion and portal vein occlusion will be compared, and a multivariate analysis will be performed to identify independent risk factors for MINS, providing a basis for early recognition and prevention of MINS.
Detailed description
This observational cohort study consists of both retrospective and prospective components. The study population includes patients undergoing major hepato-biliary surgery (defined as operative time > 4 hours and postoperative ICU admission) who are either ≥ 65 years old or ≥ 45 years old with cardiovascular risk factors (especially known cardiovascular disease). The exposed group (Pringle group) consists of patients who experience liver ischemia-reperfusion injury due to Pringle occlusion during surgery. The control group (Portal vein group) consists of patients who experience liver ischemia-reperfusion injury due to Portal vein occlusion. The primary outcome is the incidence of MINS (myocardial injury after non-cardiac surgery) within 3 days postoperatively. Secondary outcomes include postoperative length of hospital stay, incidence of complications within 30 days postoperatively, and 1-year survival rate. Finally, liver and blood samples will be collected from a subset of patients in the prospective LIRI group for pathophysiological mechanism investigation.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Portal vein | – | –The patient will experience and only experience portal vein occlusion during the surgery. |
| Pringle | – | –The patient will experience Pringle occlusion during the surgery. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- As of February 2024, patients ≥ 65 years old, or ≥ 45 years old with cardiovascular risk factors (especially known cardiovascular disease), who have undergone or are scheduled to undergo elective major hepatopancreatobiliary surgery under general anesthesia are being recruited/enrolled.
Key inclusion criteria (4 listed)
- Age ≥ 65 years, or ≥ 45 years with cardiovascular risk factors (especially known cardiovascular disease).
- Undergoing elective major hepatopancreatobiliary surgery under general anesthesia.
- ASA physical status II-III.
- Provide written informed consent to participate in the study (applicable to the prospective cohort).
Key exclusion criteria (5 listed)
- Emergency surgery
- Preoperative diagnosis of myocardial infarction or unstable angina
- Severe hepatic insufficiency (Child-Pugh class C)
- Concomitant severe organ dysfunction (e.g., renal failure, respiratory failure)
- Concomitant active infectious disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Myocardial injury after non-cardiac surgery (MINS)
Time frame: Within 3 days after surgery
MINS, a high-sensitivity troponin T (hs-cTnT) of 20 to <65 ng/L with an absolute change of at least 5 ng/L
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Derived from this study: PubMed 42477388Duan Y, Zhang Z, Wei J, Wen Q, Ding L, Wang Y, Lu Q, Gao Z. Selective portal vein occlusion and myocardial injury after major hepatobiliary surgery: a propensity-weighted cohort study. Sci Rep. 2026 Jul 20. doi: 10.1038/s41598-026-63106-w. Online ahead of print.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Injury After Non-Cardiac Surgery and Ischemia Reperfusion Injury, run by Beijing Tsinghua Chang Gung Hospital at 2 sites 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial injury after non-cardiac surgery (MINS) (time frame: Within 3 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06895798, which also lists 1 linked publication.
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 12 Jun 2026.