Left Atrial Enlargement: A Crucial Indicator for Identifying Atrial Fibrillation in Patients With Hypertension

NCT ID: NCT06359873

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 58427 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-05-01

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.

Conditions

Atrial Fibrillation; Hypertension,Essential; Left Atrial Dilatation

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Discovery dataset

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. To ensure robustness, the investigators applied the createDataPartition function in the caret package to randomly split the dataset into a discovery dataset (70%) and an internal validation dataset (30%).

CHA2DS2-VASc score, C2HEST score, and left atrial diameter (LAD)

Intervention Type: DIAGNOSTIC_TEST

CHA2DS2-VASc Score: Congestive heart failure (HF) [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].

C2HEST Score: 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 HF [2 points]; and thyroid disease [1 point for hyperthyroidism][10].

LAD: The LAD values of the enrolled patients were extracted by keyword search based on the results of echocardiography in the database.

Internal validation dataset

The datasets utilized in this study were sourced from the electronic medical record system of the Second Affiliated Hospital of Chongqing Medical University. The investigators applied the createDataPartition function in the caret package to randomly split the dataset into a discovery dataset (70%) and an internal validation dataset (30%).

CHA2DS2-VASc score, C2HEST score, and left atrial diameter (LAD)

Intervention Type: DIAGNOSTIC_TEST

CHA2DS2-VASc Score: Congestive heart failure (HF) [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].

C2HEST Score: 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 HF [2 points]; and thyroid disease [1 point for hyperthyroidism][10].

LAD: The LAD values of the enrolled patients were extracted by keyword search based on the results of echocardiography in the database.

External validation dataset

The electronic medical record data of patients who came from other hospitals based in Chongqing from October 2011 to November 2021 were extracted from the DEMR database of the Medical Data Institute of Chongqing Medical University as external validation dataset.

CHA2DS2-VASc score, C2HEST score, and left atrial diameter (LAD)

Intervention Type: DIAGNOSTIC_TEST

CHA2DS2-VASc Score: Congestive heart failure (HF) [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].

C2HEST Score: 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 HF [2 points]; and thyroid disease [1 point for hyperthyroidism][10].

LAD: The LAD values of the enrolled patients were extracted by keyword search based on the results of echocardiography in the database.

Interventions

CHA2DS2-VASc score, C2HEST score, and left atrial diameter (LAD)

CHA2DS2-VASc Score: Congestive heart failure (HF) [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].

C2HEST Score: 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 HF [2 points]; and thyroid disease [1 point for hyperthyroidism][10].

LAD: The LAD values of the enrolled patients were extracted by keyword search based on the results of echocardiography in the database.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yuehui Yin

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuehui Yin, MD

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Chongqing Medical University

Locations

2ndChongqingMU

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

LAD-AF

Identifier Type: -

Identifier Source: org_study_id