Construction and Validation of an In-hospital Mortality Risk Prediction Model for Acute Ischemic Stroke Patients

Firstly, the application effect of the existing predictive models, SOAR and GWTG-Stroke, was verified in Guangdong acute ischemic Stroke population, and the clinical application effect of the existing predictive models was verified.

Secondly, the predictive value of clinical indicators was analyzed, SOAR and GWTG-Stroke scores were optimized, and an improved prediction Model (New Model) was constructed.

The third is to apply the New Model to clinical practice, collect clinical data and evaluate the prediction effect of the Model, and evaluate the prediction efficiency of the improved prediction Model.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Ischemic Stroke

Detailed Description

This research is mainly divided into two parts. The first part is to verify and optimize the existing prediction model. Through continuous collection of clinical data of acute ischemic Stroke patients hospitalized in Shenzhen Second People's Hospital from January 2017 to December 2021, including baseline indicators and end point events, based on the existing prediction model (SOAR, GWTG-Stroke), The predictive probability was calculated and compared with the actual mortality during hospitalization. The ROC curve, calibration curve and decision curve were used to evaluate the model's differentiation, calibration and clinical application value.

Using retrospective data, multivariate logistic regression was used to analyze the predictive value of baseline clinical indicators, screen risk factors, and optimize the prediction model of SOAR and GWTG-Stroke.

Extreme Gradient Boosting (XGBOOST) was used to select variables, and logistic regression model was used based on Akaike Information Criterion.

AIC) was used to construct an improved mortality risk prediction Model (New Model). Decision curves were used to compare the models. Combined with the clinical significance of the indicators, the construction of the prediction Model was improved.

The model was validated internally by resampling with computer simulation. The second part is to evaluate the clinical application effect of the improved prediction Model. The clinical data of acute ischemic stroke patients hospitalized in Shenzhen Second People's Hospital and Shenzhen Longhua District People's Hospital from January 2022 to December 2023 are collected continuously. The New Model is applied in the clinic, and the New Model is validated in the external time and space.

Evaluate prediction effectiveness and extrapolation.

• Study Type: Observational
• Enrollment (Anticipated): 234

Contacts and Locations

• Study Contact: Name: Gao Yan, Ph.D; Phone Number: 13660367430; Email: gaoyanluoyang163@.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Clinical data of acute ischemic stroke patients hospitalized in Shenzhen Second People's Hospital and Shenzhen Longhua District People's Hospital

Description

Inclusion Criteria:

1. ≥18 years old;
2. It meets the diagnostic criteria of China Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018, and bleeding is confirmed by head MRI or excluded by CT after admission;
3. Admission within 72 hours of onset. -

Exclusion Criteria:

1. Non-vascular causes and transient ischemic attack;
2. with severe hepatic and renal dysfunction;
3. Central nervous system infection, recent history of severe trauma, and malignant tumors affecting survival time;
4. Incomplete main clinical data. -

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital mortality	Deaths during hospitalization in patients with acute ischemic stroke	7-day in-hospital mortality rates

Collaborators and Investigators

• Sponsor: Shenzhen Second People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: In-hospital mortality
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: 20213357006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No