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

NCT07735689 | Not Yet Recruiting

• 1 other identifier: 2026KY670
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiovascular Diseases (CVD); Postoperative

Keywords

cardiovascular diseases; Modified Shock Index; Noncardiac Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  1-7 days after surgery

• Incidence of the composite cardiovascular adverse event at 30 days and at 180 days after surgery

  30 days after surgery and 180 days after surgery

• All-cause mortality at 30 days and at 180 days

  30 days after surgery and 180 days after surgery

Study Arms (2)

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.

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Xiaopin Xu

CONTACT

+8613167161220; Lxv15860845080@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 30, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share