Myocardial Injury After Noncardiac Surgery (MINS)NCT07094321
Study on the Correlation Between Intraoperative Hypotension and Postoperative Myocardial Injury
An observational study of Myocardial Injury After Noncardiac Surgery (MINS) and Hypotension During Surgery, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
The investigators are conducting an important study aimed at better understanding and predicting a potential complication after non-cardiac surgery: myocardial injury. This research is crucial for enhancing surgical safety and improving patient outcomes. Read more about this study
- Who is it for?
- Ages 12 to 100 years
- Conditions the study is for
- Myocardial Injury After Noncardiac Surgery (MINS), Hypotension During Surgery
- How many people
- 8,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Dec 2028
- Phase
- Observational
- 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 12 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study retrospectively includes adult patients (aged 12 years and older) who underwent elective, non-cardiac, non-emergency surgery under general anesthesia at China-Japan Friendship Hospital between January 2020 and December 2025. All included patients had a surgical duration exceeding 1 hour and an American Society of Anesthesiologists (ASA) physical status classification of I to III. A key criterion for inclusion was the availability of at least one cardiac injury marker test within 7 days post-surgery for outcome assessment. Patients undergoing organ transplant surgery or those with significant periods of missing or invalid intraoperative vital signs data (more than 10 consecutive minutes) will be excluded. The study cohort is expected to consist of approximately 8,000 patients, from whom detailed intraoperative hemodynamic data, patient demographics, comorbidities, surgical characteristics, and postoperative outcomes will be extracted for analysis.
Who may be able to join
- Patients who underwent elective non-cardiac, non-emergency surgery with general anesthesia at China-Japan Friendship Hospital between 2020 and 2025.
- Surgical duration greater than 1 hour.
- Received at least one cardiac injury marker test (e.g., troponin) within 7 days post-surgery.
- Patients with American Society of Anesthesiologists (ASA) physical status classification of I-III.
Who cannot join
- Patients younger than 12 years old.
- Patients undergoing organ transplant surgery.
- Patients with more than 10 consecutive minutes of invalid or missing intraoperative vital signs data.
- Patients with critical missing data that cannot be reasonably imputed (general data completeness issues).
Trial locations and contacts
1 site in 1 country.
China1 site
China-japan Friendship Hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: Predicting Postoperative Myocardial Injury: A Retrospective Cohort Study Comparing Absolute Versus Relative Definitions of Intraoperative Hypotension
The investigators are conducting an important study aimed at better understanding and predicting a potential complication after non-cardiac surgery: myocardial injury. This research is crucial for enhancing surgical safety and improving patient outcomes.
Simply put, postoperative myocardial injury (PMI) means that heart muscle cells are damaged after non-cardiac surgery. While it might not cause obvious chest pain like a heart attack, it can show up as abnormalities on an electrocardiogram (ECG) or in blood tests (like elevated troponin levels). This type of injury is a significant factor contributing to postoperative complications and even mortality.
Read more
During surgery, hypotension-or low blood pressure-is a common occurrence. The investigators know that maintaining adequate blood pressure is essential for the heart to receive a sufficient blood supply. If blood pressure drops too low, the heart's blood supply can be reduced, potentially leading to oxygen deprivation and damage to heart muscle cells.
While it's widely accepted that low blood pressure is linked to myocardial injury, precisely defining "low blood pressure" during surgery has been a persistent challenge.
- Historically, the investigators have focused on the "absolute value" of blood pressure, such as a fixed mean arterial pressure (MAP) threshold (e.g., below 65 mmHg). Many studies have indeed shown that MAP below 65 mmHg, especially for extended periods, increases the risk of PMI.
- However, recent research is starting to challenge this perspective. Some studies have found that even maintaining a relatively higher blood pressure during surgery (e.g., MAP above 75 mmHg) didn't significantly reduce the incidence of PMI. This suggests that simply looking at a fixed blood pressure number might not tell the whole story.
Our preliminary research uncovered an intriguing finding: even if a patient's absolute blood pressure value during surgery seemed acceptable (e.g., above 60 mmHg), their risk of postoperative myocardial injury significantly increased if that pressure had dropped by more than 40% from their individual "normal" pre-operative blood pressure. Based on this discovery, our study proposes a novel hypothesis: the percentage drop in MAP from an individual's baseline might be more strongly correlated with postoperative myocardial injury and a better predictor of risk than the absolute MAP value.
The investigators will be reviewing patient data from non-cardiac surgeries performed at China-Japan Friendship Hospital between 2020 and 2025. The investigators will meticulously analyze these patients' intraoperative blood pressure changes (considering both absolute values and the percentage change from their pre-operative baseline) and compare these findings with whether they developed myocardial injury after surgery.
Our study's goal is to determine which definition of low blood pressure (absolute value or percentage drop from baseline) is more closely related to postoperative myocardial injury.
The investigators will collect detailed patient information, including demographics, past medical history, pre- and post-operative test results, intraoperative vital signs (blood pressure, heart rate, oxygen saturation, etc., recorded every 15 seconds), and intraoperative medications. All data will undergo rigorous statistical analysis to ensure the scientific validity and reliability of our findings.
The results of this study will help us more accurately identify patients at high risk for postoperative myocardial injury. If our hypothesis is confirmed, it means that during surgery, doctors, in addition to monitoring absolute blood pressure values, will pay closer attention to the degree of blood pressure drop relative to a patient's own normal baseline. This will help to:
- Improve understanding of individual patient differences: Recognizing that what's "normal" for one patient might be too low for another.
- Enable more precise adjustments in anesthesia and surgical management: Allowing for timely interventions to maintain optimal heart muscle perfusion, thereby reducing the incidence of postoperative myocardial injury.
- Ultimately, enhance patient safety during surgery and improve their recovery and long-term outcomes.
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 |
|---|---|---|
| MINS group | Patients who experienced postoperative cardiac dysfunction | |
| Non-MINS group | Patients who did not experience postoperative cardiac dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of postoperative myocardial injury
PMI is defined as an elevation of cardiac troponin (e.g., high-sensitivity troponin I or T) levels above the 99th percentile upper reference limit (URL) of the local institutional laboratory within 7 days following non-cardiac surgery. This outcome will be assessed based on routine postoperative cardiac biomarker measurements performed as part of standard clinical care. PMI serves as a critical indicator for evaluating cardiac damage post-surgery and is closely associated with adverse patient outcomes and prognosis.
Measured: Within 7 days following non-cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Jan 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Injury After Noncardiac Surgery (MINS)Studies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kan Wang, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094321
- Sponsor's protocol ID
- ChinaJapanFH
- Status last verified
- Aug 2025
- First submitted
- 23 Jul 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Postoperative Myocardial Injury: A Retrospective Cohort Study Comparing Absolute Versus Relative Definitions of Intraoperative Hypotension
- ClinicalTrials.gov ID
- NCT07094321
- Acronym / sponsor ID
- ChinaJapanFH
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 30 Jul 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.
The investigators are conducting an important study aimed at better understanding and predicting a potential complication after non-cardiac surgery: myocardial injury. This research is crucial for enhancing surgical safety and improving patient outcomes.
Simply put, postoperative myocardial injury (PMI) means that heart muscle cells are damaged after non-cardiac surgery. While it might not cause obvious chest pain like a heart attack, it can show up as abnormalities on an electrocardiogram (ECG) or in blood tests (like elevated troponin levels). This type of injury is a significant factor contributing to postoperative complications and even mortality.
During surgery, hypotension-or low blood pressure-is a common occurrence. The investigators know that maintaining adequate blood pressure is essential for the heart to receive a sufficient blood supply. If blood pressure drops too low, the heart's blood supply can be reduced, potentially leading to oxygen deprivation and damage to heart muscle cells.
While it's widely accepted that low blood pressure is linked to myocardial injury, precisely defining "low blood pressure" during surgery has been a persistent challenge.
- Historically, the investigators have focused on the "absolute value" of blood pressure, such as a fixed mean arterial pressure (MAP) threshold (e.g., below 65 mmHg). Many studies have indeed shown that MAP below 65 mmHg, especially for extended periods, increases the risk of PMI.
- However, recent research is starting to challenge this perspective. Some studies have found that even maintaining a relatively higher blood pressure during surgery (e.g., MAP above 75 mmHg) didn't significantly reduce the incidence of PMI. This suggests that simply looking at a fixed blood pressure number might not tell the whole story.
Our preliminary research uncovered an intriguing finding: even if a patient's absolute blood pressure value during surgery seemed acceptable (e.g., above 60 mmHg), their risk of postoperative myocardial injury significantly increased if that pressure had dropped by more than 40% from their individual "normal" pre-operative blood pressure. Based on this discovery, our study proposes a novel hypothesis: the percentage drop in MAP from an individual's baseline might be more strongly correlated with postoperative myocardial injury and a better predictor of risk than the absolute MAP value.
The investigators will be reviewing patient data from non-cardiac surgeries performed at China-Japan Friendship Hospital between 2020 and 2025. The investigators will meticulously analyze these patients' intraoperative blood pressure changes (considering both absolute values and the percentage change from their pre-operative baseline) and compare these findings with whether they developed myocardial injury after surgery.
Our study's goal is to determine which definition of low blood pressure (absolute value or percentage drop from baseline) is more closely related to postoperative myocardial injury.
The investigators will collect detailed patient information, including demographics, past medical history, pre- and post-operative test results, intraoperative vital signs (blood pressure, heart rate, oxygen saturation, etc., recorded every 15 seconds), and intraoperative medications. All data will undergo rigorous statistical analysis to ensure the scientific validity and reliability of our findings.
The results of this study will help us more accurately identify patients at high risk for postoperative myocardial injury. If our hypothesis is confirmed, it means that during surgery, doctors, in addition to monitoring absolute blood pressure values, will pay closer attention to the degree of blood pressure drop relative to a patient's own normal baseline. This will help to:
- Improve understanding of individual patient differences: Recognizing that what's "normal" for one patient might be too low for another.
- Enable more precise adjustments in anesthesia and surgical management: Allowing for timely interventions to maintain optimal heart muscle perfusion, thereby reducing the incidence of postoperative myocardial injury.
- Ultimately, enhance patient safety during surgery and improve their recovery and long-term outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MINS group | – | –Patients who experienced postoperative cardiac dysfunction |
| Non-MINS group | – | –Patients who did not experience postoperative cardiac dysfunction |
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study retrospectively includes adult patients (aged 12 years and older) who underwent elective, non-cardiac, non-emergency surgery under general anesthesia at China-Japan Friendship Hospital between January 2020 and December 2025. All included patients had a surgical duration exceeding 1 hour and an American Society of Anesthesiologists (ASA) physical status classification of I to III. A key criterion for inclusion was the availability of at least one cardiac injury marker test within 7 days post-surgery for outcome assessment. Patients undergoing organ transplant surgery or those with significant periods of missing or invalid intraoperative vital signs data (more than 10 consecutive minutes) will be excluded. The study cohort is expected to consist of approximately 8,000 patients, from whom detailed intraoperative hemodynamic data, patient demographics, comorbidities, surgical characteristics, and postoperative outcomes will be extracted for analysis.
Key inclusion criteria (4 listed)
- Patients who underwent elective non-cardiac, non-emergency surgery with general anesthesia at China-Japan Friendship Hospital between 2020 and 2025.
- Surgical duration greater than 1 hour.
- Received at least one cardiac injury marker test (e.g., troponin) within 7 days post-surgery.
- Patients with American Society of Anesthesiologists (ASA) physical status classification of I-III.
Key exclusion criteria (4 listed)
- Patients younger than 12 years old.
- Patients undergoing organ transplant surgery.
- Patients with more than 10 consecutive minutes of invalid or missing intraoperative vital signs data.
- Patients with critical missing data that cannot be reasonably imputed (general data completeness issues).
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
occurrence of postoperative myocardial injury
Time frame: Within 7 days following non-cardiac surgery
PMI is defined as an elevation of cardiac troponin (e.g., high-sensitivity troponin I or T) levels above the 99th percentile upper reference limit (URL) of the local institutional laboratory within 7 days following non-cardiac surgery. This outcome will be assessed based on routine postoperative cardiac biomarker measurements performed as part of standard clinical care. PMI serves as a critical indicator for evaluating cardiac damage post-surgery and is closely associated with adverse patient outcomes and prognosis.
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 29 Aug 2025.
- Individual participant dataSharing planned: No
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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.
1 site 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 Noncardiac Surgery (MINS) and Hypotension During Surgery, run by China-Japan Friendship Hospital 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 29 Aug 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?
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?
occurrence of postoperative myocardial injury (time frame: Within 7 days following non-cardiac surgery). 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 29 Aug 2025.