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临床试验/NCT06359873
NCT06359873已完成不适用

To Investigate the Early Warning Effect of CHA2DS2-VASc Score and Left Atrial Diameter on Atrial Fibrillation in Patients With Hypertension

The Second Affiliated Hospital of Chongqing Medical University1 个研究点 分布在 1 个国家目标入组 58,427 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
58,427
试验地点
1
主要终点
C2HEST score

研究概览

简要总结

Based on the data of inpatients with hypertension and a cross-sectional study with a large sample size, this study aims to find the early warning value of the left anteroposterior atrial diameter for the possible occurrence of atrial fibrillation in patients with hypertension, and compare the advantages and disadvantages of the above two methods for the early warning of the risk of atrial fibrillation in patients with hypertension, so as to achieve the purpose of early identification of high-risk groups that may develop atrial fibrillation.

详细描述

Background Left atrial enlargement resulting from hypertension is closely linked to the development and persistence of atrial fibrillation (AF). The newly proposed staging recognizes AF as disease continuum, which makes us aware that AF prevention should focus on the Pre-AF stage, and atrial enlargement is one of the important manifestations in this stage. Previous scoring systems, such as CHA2DS2-VASc and C2HEST, along with the recently highlighted left atrial diameter (LAD), have been significant tools for predicting AF occurrence. However, a comprehensive assessment of their utility is currently lacking.

Purpose This study aims to explore the role of left atrial size in identifying atrial fibrillation (AF) among hospitalized hypertensives, and to compare its recognition effectiveness with previous scoring systems.

Methods The investigators conducted a cross-sectional analysis within hospitalized hypertensives. The discovery, internal and external validation datasets were established. The eXtreme Gradient Boosting (XGBoost) was employed to identify key variables related to AF occurrence, which were ranked based on their importance scores. To gauge the predictive prowess of LAD regarding AF occurrence, the investigators plotted the receiver operating characteristic curve (ROC) and calculated the area under the curve (AUC). This enabled us to pinpoint the LAD cutoff value corresponding to the maximum Youden index, indicative of susceptibility to AF. Subsequently, Youden index determined the optimal cutoff value from the ROC curve. Delong's test compared the identification abilities of different tools within the same dataset. Logistic regression analysis assessed the correlation between clinical variables and left atrial size.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

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

入选标准

  • Patients with a diagnosis of primary hypertension using the current or past medical history.
  • Availability of one or more complete ECG and 24h holter data.
  • Availability of complete echocardiogram data in the current hospitalization.

排除标准

  • Patients under 18 years of age.
  • Cases with incomplete or unidentifiable results from extracted data.

结局指标

主要结局

C2HEST score

时间窗: Data collection was completed after discharge from the hospital, up to 3 months.

The patients' discharge material were extracted from the database, including age, and history of coronary artery disease, chronic obstructive pulmonary disease, hypertension, systolic heart failure, thyroid disease. C2HEST score was calculated according to the guidelines (C2HEST criteria: Coronary artery disease or chronic obstructive pulmonary disease \[1 point each, 2 total points\]; hypertension \[1 point\]; elderly \[2 points for age ≥ 75 years\]; systolic heart failure \[2 points\]; and thyroid disease \[1 point for hyperthyroidism\]), with the highest score being 8 and the lowest score being 0. Then, the C2HEST score was calculated by the investigator based on the above diagnosis. The higher the score, the higher the risk of AF.

Atrial fibrillation (AF)

时间窗: Data collection was completed after discharge from the hospital, up to 3 months.

Diagnostic criteria for AF: The preferred indicators for confirming the diagnosis of AF were normal ECG and ambulatory ECG. During physical examination, the patient's heart rhythm is absolutely irregular and the first heart sound is uneven in strength. Patients may also present with clinical manifestations such as palpitations, dizziness, dyspnea, and chest tightness during the course of the disease. The above materials of the patients were recorded in the electronic medical record system.

left atrial diameter (LAD)

时间窗: Data collection was completed after discharge from the hospital, up to 3 months.

In this study, after the patients completed the cardiac color Doppler ultrasound, the report and results would be uploaded to the electronic medical record system. Then, the investigator would extract the LAD values recorded in the report from this database.

CHA2DS2-VASc score

时间窗: Data collection was completed after discharge from the hospital, up to 3 months.

The patients' discharge material were extracted from the database, including age, gender, and history of congestive heart failure, hypertension, diabetes, stroke or transient ischemic attacks, and vascular disease. CHA2DS2-VASc score was calculated according to the guidelines (CHA2DS2-VASc criteria: Congestive heart failure \[1 point\], hypertension \[1 point\], age ≥ 75 years \[2 points\], diabetes \[1 point\], prior stroke or transient ischemic attack \[2 points\], vascular disease \[1 point\], age 65-74 years \[1 point\], and female gender\[1 point\]), with the highest score being 9 and the lowest score being 0. Then, the CHA2DS2-VASc score was calculated by the investigator based on the above diagnosis. The higher the score, the higher the risk of AF.

次要结局

  • AUC of CHA2DS2-VASc score and occurrence of AF(Statistics were completed after data collection, up to 1 months.)
  • AUC of C2HEST score and occurrence of AF(Statistics were completed after data collection, up to 1 months.)
  • Area under the curve (AUC) of LAD and occurrence of AF(Statistics were completed after data collection, up to 1 months.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuehui Yin

Prof. Yuehui Yin, Director, Head of Cardiovascular Medicine, Principal Investigator, Clinical Professor

The Second Affiliated Hospital of Chongqing Medical University

研究点 (1)

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