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NCT Number: NCT07735689

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

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. All-cause mortality at 30 days and at 180 days

    Time frame: 30 days after surgery and 180 days after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaopin Xu

CONTACT

[email protected]

+8613167161220

Sponsors and collaborators

Lead sponsor

Fujian Medical University Union Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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