Clinical trial NCT06359873: Left Atrial Enlargement: A Crucial Indicator for Identifying Atrial Fibrillation in Patients With Hypertension
Official title: To Investigate the Early Warning Effect of CHA2DS2-VASc Score and Left Atrial Diameter on Atrial Fibrillation in Patients With Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Hypertension,Essential
Left Atrial Dilatation
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 58427
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The electronic medical records of inpatients with primary hypertension from March 2012 to February 2018 were collected from the electronic medical record system of the Second Affiliated Hospital of Chongqing Medical University, and the data were derived from electronic case reports. Furthermore, the electronic medical record data of patients in other hospitals from October 2011 to November 2021 were extracted from the DEMR database as external data. The extraction of discharge diagnoses relied on International Classification of Diseases (ICD) hospitalization discharge codes. Patient information within the database was kept anonymous and safeguarded by unique identification numbers to ensure strict confidentiality. Importantly, the retrospective nature of this study had no influence on the medical care processes of the subjects, and it received ethical approval from the Medical Ethics Committee of the Second Affiliated Hospital of Chongqing Medical University.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: left atrial diameter (LAD)
timeFrame: Data collection was completed after discharge from the hospital, up to 3 months.
measure: CHA2DS2-VASc score
timeFrame: Data collection was completed after discharge from the hospital, up to 3 months.
measure: C2HEST score
timeFrame: Data collection was completed after discharge from the hospital, up to 3 months.
measure: Atrial fibrillation (AF)
timeFrame: Data collection was completed after discharge from the hospital, up to 3 months.
Secondary outcomes:
measure: Area under the curve (AUC) of LAD and occurrence of AF
timeFrame: Statistics were completed after data collection, up to 1 months.
measure: AUC of CHA2DS2-VASc score and occurrence of AF
timeFrame: Statistics were completed after data collection, up to 1 months.
measure: AUC of C2HEST score and occurrence of AF
timeFrame: Statistics were completed after data collection, up to 1 months.
Other outcomes:
measure: the LAD cutoff value
timeFrame: Statistics were completed after data collection, up to 1 months.
Locations:
city: Chongqing
country: China
facility: 2ndChongqingMU
state: Chongqing
Study officials:
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Yuehui Yin, MD
role: PRINCIPAL_INVESTIGATOR
References: