Cardiovascular Diseases (CVD)NCT07735689
Evaluate the Value of Modified Shock Index in Predicting the Incidence of Cardiovascular Events After Non-cardiac Surgery in Cardiac Patients
An observational study of Cardiovascular Diseases (CVD) and Postoperative, run by Fujian Medical University Union Hospital.
Trial summary
The objective of this study is to evaluate the efficacy of the modified shock index (MSI) in predicting the incidence of postoperative cardiovascular events (PCEs) in patients with pre-existing cardiac disease undergoing non-cardiac surgery. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cardiovascular Diseases (CVD), Postoperative
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Dec 2026
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent gastric or colorectal surgery at Fujian Medical University Union Hospital between January 2020 and December 2025, and who met all inclusion criteria and none of the exclusion criteria.
Who may be able to join
- (1) Age ≥45 years. (2) Underwent elective major abdominal surgery with a duration of ≥2 hours at Fujian Medical University Union Hospital between January 2020 and December 2025.
- Presence of any of the following: history of heart disease; elevated BNP or cardiac troponin within 30 days before surgery; or at least two cardiac risk factors.
- Complete electronic medical records available.
Who cannot join
- (1) ASA ≥ V. (2) Acute cardiovascular event. (3) Severe uncontrolled hypertension. (4) End-stage renal disease. (5) Sepsis. (6) Preoperative requirement for vasopressor support. (7) Pregnancy. (8) Missing >20% of key clinical data. (9) Loss to follow-up or refusal to consent to the use of medical records.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The objective of this study is to evaluate the efficacy of the modified shock index (MSI) in predicting the incidence of postoperative cardiovascular events (PCEs) in patients with pre-existing cardiac disease undergoing non-cardiac surgery. A retrospective analysis was performed on the clinical data of patients who underwent gastric, colorectal, and hepatobiliary surgeries at Union Hospital Affiliated to Fujian Medical University between January 2020 and December 2025. Baseline characteristics, intraoperative vital signs, occurrence of postoperative cardiac complications, and total postoperative hospital stay were reviewed and summarized to assess the predictive performance of the MSI for PCEs in this patient population.
Read the detailed description
This study aims to evaluate the efficacy of the modified shock index (MSI) in predicting postoperative cardiovascular events (PCEs) in cardiac patients undergoing non-cardiac surgery. A retrospective analysis was conducted on clinical data from patients who underwent gastrointestinal and hepatobiliary surgeries at Fujian Medical University Union Hospital between January 2020 and December 2025. Baseline characteristics, intraoperative vital signs, occurrence of cardiac complications, and total postoperative hospital stay were analyzed to determine the optimal MSI cutoff values, sensitivity, specificity, and Youden's index for PCE prediction. The study further elucidates pathophysiological mechanisms linking MSI thresholds to organ hypoperfusion, providing an evidence-based tool for individualized perioperative hemodynamic management.
- Conditions
- Cardiovascular Diseases (CVD), Postoperative
- Keywords
- cardiovascular diseases, Modified Shock Index, Noncardiac Surgical Procedures
- Medical subject headings
- Cardiovascular Diseases
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 |
|---|---|---|
| Event Group (Postoperative In-Hospital Cardiovascular Adverse Events) | After major abdominal surgery, patients meeting any of the following are assigned to the event group: Myocardial injury/infarction: Postoperative cTnT above upper limit, ± new ischemic ECG changes, new wall motion abnormality on echocardiography, or pulmonary edema on chest X-ray; cTnT elevation without non-cardiac cause = myocardial injury after non-cardiac surgery. Acute heart failure: Dyspnea/crackles needing diuretic/vasodilator, plus ≥1 of: BNP >400 pg/mL, NT-proBNP >1800 pg/mL, pulmonary congestion/edema on chest X-ray, or echocardiography showing LVEF drop ≥10% or acute diastolic worsening. Serious arrhythmia: Sustained ventricular tachycardia/fibrillation needing urgent intervention; new rapid atrial fibrillation with hemodynamic instability; high-degree atrioventricular block needing temporary pacing; or resuscitated cardiac arrest. Cardiac death: Death due to above events, supported by cTnT, BNP, ECG, echocardiography, or chest X-ray, excluding definite non-cardiac causes. | |
| Non-Event Group (No Postoperative In-Hospital Cardiovascular Adverse Events) | After major abdominal surgery, patients are assigned to the non-event group if none of the above events occurred. They must also meet: peak postoperative cTnT remains normal, or if mildly elevated, a definite non-cardiac cause is identified with no cardiovascular symptoms or treatment; no diagnosis or treatment for acute heart failure, serious arrhythmia, or cardiac death documented; isolated mild BNP elevation without clinical significance, occasional premature beats, or other non-urgent findings are not counted as events. |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital cardiovascular adverse events
Myocardial injury/infarction: Postop cTnT > upper limit, ± new ischemic ECG, new wall motion abnormality on echocardiography, or CXR pulmonary edema.
Acute heart failure: Dyspnea/crackles needing diuretic/vasodilator, plus ≥1: BNP >400 pg/mL, NT-proBNP >1800 pg/mL, CXR congestion/edema, or echocardiographic LVEF drop ≥10% or acute diastolic worsening.
Serious arrhythmia: Sustained VT/VF needing urgent intervention; new rapid atrial fibrillation with hemodynamic instability; high-degree atrioventricular block needing temporary pacing; or resuscitated cardiac arrest.
Cardiac death: Death from above events, supported by cTnT, BNP, ECG, echocardiography, or CXR, excluding definite non-cardiac causes.
Measured: 1-7 days after surgery
Secondary outcomes (3)
Incidence of each individual component of the primary composite endpoint during the in-hospital period (myocardial injury/infarction, acute heart failure, serious arrhythmia, cardiac death)
Measured: 1-7 days after surgery
Incidence of the composite cardiovascular adverse event at 30 days and at 180 days after surgery
Measured: 30 days after surgery and 180 days after surgery
All-cause mortality at 30 days and at 180 days
Measured: 30 days after surgery and 180 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 posted30 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Diseases (CVD)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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735689
- Sponsor's protocol ID
- 2026KY670
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- 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 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Value of Modified Shock Index in Predicting the Incidence of Cardiovascular Events After Non-cardiac Surgery in Cardiac Patients
- ClinicalTrials.gov ID
- NCT07735689
- Acronym / sponsor ID
- 2026KY670
- Conditions
- Cardiovascular Diseases (CVD), Postoperative
- Keywords
- cardiovascular diseases, Modified Shock Index, Noncardiac Surgical Procedures
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Jul 2026 (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 objective of this study is to evaluate the efficacy of the modified shock index (MSI) in predicting the incidence of postoperative cardiovascular events (PCEs) in patients with pre-existing cardiac disease undergoing non-cardiac surgery. A retrospective analysis was performed on the clinical data of patients who underwent gastric, colorectal, and hepatobiliary surgeries at Union Hospital Affiliated to Fujian Medical University between January 2020 and December 2025. Baseline characteristics, intraoperative vital signs, occurrence of postoperative cardiac complications, and total postoperative hospital stay were reviewed and summarized to assess the predictive performance of the MSI for PCEs in this patient population.
Detailed description
This study aims to evaluate the efficacy of the modified shock index (MSI) in predicting postoperative cardiovascular events (PCEs) in cardiac patients undergoing non-cardiac surgery. A retrospective analysis was conducted on clinical data from patients who underwent gastrointestinal and hepatobiliary surgeries at Fujian Medical University Union Hospital between January 2020 and December 2025. Baseline characteristics, intraoperative vital signs, occurrence of cardiac complications, and total postoperative hospital stay were analyzed to determine the optimal MSI cutoff values, sensitivity, specificity, and Youden's index for PCE prediction. The study further elucidates pathophysiological mechanisms linking MSI thresholds to organ hypoperfusion, providing an evidence-based tool for individualized perioperative hemodynamic management.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Event Group (Postoperative In-Hospital Cardiovascular Adverse Events) | – | –After major abdominal surgery, patients meeting any of the following are assigned to the event group: Myocardial injury/infarction: Postoperative cTnT above upper limit, ± new ischemic ECG changes, new wall motion abnormality on echocardiography, or pulmonary edema on chest X-ray; cTnT elevation without non-cardiac cause = myocardial injury after non-cardiac surgery. Acute heart failure: Dyspnea/crackles needing diuretic/vasodilator, plus ≥1 of: BNP >400 pg/mL, NT-proBNP >1800 pg/mL, pulmonary congestion/edema on chest X-ray, or echocardiography showing LVEF drop ≥10% or acute diastolic worsening. Serious arrhythmia: Sustained ventricular tachycardia/fibrillation needing urgent intervention; new rapid atrial fibrillation with hemodynamic instability; high-degree atrioventricular block needing temporary pacing; or resuscitated cardiac arrest. Cardiac death: Death due to above events, supported by cTnT, BNP, ECG, echocardiography, or chest X-ray, excluding definite non-cardiac causes. |
| Non-Event Group (No Postoperative In-Hospital Cardiovascular Adverse Events) | – | –After major abdominal surgery, patients are assigned to the non-event group if none of the above events occurred. They must also meet: peak postoperative cTnT remains normal, or if mildly elevated, a definite non-cardiac cause is identified with no cardiovascular symptoms or treatment; no diagnosis or treatment for acute heart failure, serious arrhythmia, or cardiac death documented; isolated mild BNP elevation without clinical significance, occasional premature beats, or other non-urgent findings are not counted as events. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent gastric or colorectal surgery at Fujian Medical University Union Hospital between January 2020 and December 2025, and who met all inclusion criteria and none of the exclusion criteria.
Key inclusion criteria (3 listed)
- (1) Age ≥45 years. (2) Underwent elective major abdominal surgery with a duration of ≥2 hours at Fujian Medical University Union Hospital between January 2020 and December 2025.
Key exclusion criteria (1 listed)
- (1) ASA ≥ V. (2) Acute cardiovascular event. (3) Severe uncontrolled hypertension. (4) End-stage renal disease. (5) Sepsis. (6) Preoperative requirement for vasopressor support. (7) Pregnancy. (8) Missing >20% of key clinical data. (9) Loss to follow-up or refusal to consent to the use of medical records.
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
In-hospital cardiovascular adverse events
Time frame: 1-7 days after surgery
Myocardial injury/infarction: Postop cTnT > upper limit, ± new ischemic ECG, new wall motion abnormality on echocardiography, or CXR pulmonary edema. Acute heart failure: Dyspnea/crackles needing diuretic/vasodilator, plus ≥1: BNP >400 pg/mL, NT-proBNP >1800 pg/mL, CXR congestion/edema, or echocardiographic LVEF drop ≥10% or acute diastolic worsening. Serious arrhythmia: Sustained VT/VF needing urgent intervention; new rapid atrial fibrillation with hemodynamic instability; high-degree atrioventricular block needing temporary pacing; or resuscitated cardiac arrest. Cardiac death: Death from above events, supported by cTnT, BNP, ECG, echocardiography, or CXR, excluding definite non-cardiac causes.
3 secondary outcomes
Incidence of each individual component of the primary composite endpoint during the in-hospital period (myocardial injury/infarction, acute heart failure, serious arrhythmia, cardiac death)
Time frame: 1-7 days after surgery
Incidence of the composite cardiovascular adverse event at 30 days and at 180 days after surgery
Time frame: 30 days after surgery and 180 days after surgery
All-cause mortality at 30 days and at 180 days
Time frame: 30 days after surgery and 180 days after surgery
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 30 Jul 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases (CVD) and Postoperative, run by Fujian Medical University Union Hospital.
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 3 inclusion and 1 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 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Xiaopin Xu (+8613167161220, Lxv15860845080@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital cardiovascular adverse events (time frame: 1-7 days after 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 30 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.