Atrial Fibrillation Clinical Trial
Official title:
To Investigate the Early Warning Effect of CHA2DS2-VASc Score and Left Atrial Diameter on Atrial Fibrillation in Patients With Hypertension
NCT number | NCT06359873 |
Other study ID # | LAD-AF |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2022 |
Est. completion date | May 1, 2023 |
Verified date | April 2024 |
Source | The Second Affiliated Hospital of Chongqing Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 58427 |
Est. completion date | May 1, 2023 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | 2ndChongqingMU | Chongqing | Chongqing |
Lead Sponsor | Collaborator |
---|---|
The Second Affiliated Hospital of Chongqing Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | the LAD cutoff value | To facilitate clinical use, as well as to assess the predictive power of LAD for the occurrence of AF, AUC was calculated in the discovery and external datasets. This enabled us to pinpoint the LAD cutoff value corresponding to the maximum Youden index, indicative of susceptibility to AF. | Statistics were completed after data collection, up to 1 months. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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 | Area under the curve (AUC) of LAD and occurrence of AF | To assess the ability of LAD to predict the occurrence of AF, the investigators used IBM SPSS 26.0 software to create a receiver operating characteristic curve (ROC) and calculate the AUC in the discovery and external datasets, with LAD as the independent variable and the occurrence of AF as the dependent variable. | Statistics were completed after data collection, up to 1 months. | |
Secondary | AUC of CHA2DS2-VASc score and occurrence of AF | To gauge the predictive prowess of CHA2DS2-VASc scores regarding AF occurrence, a ROC was plotted and the AUC was calculated in the discovery and external datasets, with CHA2DS2-VASc score as the independent variable and the occurrence of AF as the dependent variable. | Statistics were completed after data collection, up to 1 months. | |
Secondary | AUC of C2HEST score and occurrence of AF | To gauge the predictive prowess of C2HEST scores regarding AF occurrence, a ROC was plotted and the AUC was calculated in the discovery and external datasets, with C2HEST score as the independent variable and the occurrence of AF as the dependent variable. | Statistics were completed after data collection, up to 1 months. |
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