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临床试验/NCT07735689
NCT07735689尚未招募不适用

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

Fujian Medical University Union Hospital0 个研究点目标入组 1,500 人开始时间: 2026年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,500
主要终点
In-hospital cardiovascular adverse events

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (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
  • (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.

排除标准

  • (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.

结局指标

主要结局

In-hospital cardiovascular adverse events

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

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