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

NCT06359873 | Completed DMC

• 1 other identifier: LAD-AF
• Study Type: observational
• Target: 58,427
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Hypertension,Essential; Left Atrial Dilatation

Outcome Measures

Primary Outcomes (4)

• left atrial diameter (LAD)

  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.

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

• CHA2DS2-VASc score

  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.

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

• C2HEST score

  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.

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

• Atrial fibrillation (AF)

  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.

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

Secondary Outcomes (3)

• Area under the curve (AUC) of LAD and occurrence of AF

  Statistics were completed after data collection, up to 1 months.

• 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.

Other Outcomes (1)

• the LAD cutoff value

  Statistics were completed after data collection, up to 1 months.

Study Arms (3)

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%).

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

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%).

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

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.

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

Interventions

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

Discovery dataset; External validation dataset; Internal validation dataset

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

2ndChongqingMU

Chongqing, Chongqing Municipality, 400010, China

Location

MeSH Terms

Conditions

Atrial Fibrillation; Essential Hypertension

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases

Study Officials

• Yuehui Yin, MD

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Yuehui Yin, Director, Head of Cardiovascular Medicine, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 11, 2024
• Study Start: May 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: May 1, 2023
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Access Criteria: Researchers need to complete the registration information online, and they can access it after being reviewed by the Institute of Medical Data of Chongqing Medical University.

Locations

CN (1)