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Evaluate the Value of Modified Shock Index in Predicting the Incidence of Cardiovascular Events After Non-cardiac Surgery in Cardiac Patients

Evaluate the Value of Modified Shock Index in Predicting the Incidence of Cardiovascular Events After Non-cardiac Surgery in Cardiac Patients

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07735689
Enrollment
1500
Registered
2026-07-30
Start date
2026-08-01
Completion date
2026-12-01
Last updated
2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases (CVD), Postoperative

Keywords

cardiovascular diseases, Modified Shock Index, Noncardiac Surgical Procedures

Brief 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. 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.

Interventions

None listed

Sponsors

Fujian Medical University Union Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* (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. (3) 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. (4) Complete electronic medical records available.

Exclusion criteria

* (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.

Design outcomes

Primary

MeasureTime frameDescription
In-hospital cardiovascular adverse events1-7 days after surgeryMyocardial 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.

Secondary

MeasureTime frame
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)1-7 days after surgery
Incidence of the composite cardiovascular adverse event at 30 days and at 180 days after surgery30 days after surgery and 180 days after surgery
All-cause mortality at 30 days and at 180 days30 days after surgery and 180 days after surgery

Contacts

CONTACTXiaopin Xu
Lxv15860845080@163.com+8613167161220

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026