Atrial FibrillationNCT06359873
Left Atrial Enlargement: A Crucial Indicator for Identifying Atrial Fibrillation in Patients With Hypertension
An observational study of Atrial Fibrillation and Hypertension,Essential, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Hypertension,Essential, Left Atrial Dilatation
- What is being tested?
- CHA2DS2-VASc score, C2HEST score, and left atrial diameter (LAD)
- How many people
- 58,427 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients under 18 years of age.
- Cases with incomplete or unidentifiable results from extracted data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Investigate the Early Warning Effect of CHA2DS2-VASc Score and Left Atrial Diameter on Atrial Fibrillation in Patients With Hypertension
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.
Read the 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.
- Being tested
- CHA2DS2-VASc score, C2HEST score, and left atrial diameter (LAD)
- Medical subject headings
- Atrial Fibrillation, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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%). Receives: 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%). Receives: 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. Receives: Diagnostic Test: CHA2DS2-VASc score, C2HEST score, and left atrial diameter (LAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Statistics were completed after data collection, up to 1 months.
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.
Measured: Statistics were completed after data collection, up to 1 months.
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.
Measured: Statistics were completed after data collection, up to 1 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 May 2022
- Primary completion30 Sep 2022
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 58,427 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
- Investigators
- Yuehui Yin, MD, Principal investigator, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359873
- Sponsor's protocol ID
- LAD-AF
- Status last verified
- Apr 2024
- First submitted
- 26 Mar 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified electronic medical record (DEMR) data platform of Chongqing Medical University Medical Data Institute, accessible at https://demo.yiducloud.com.cn/pub/#/register.
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Early Warning Effect of CHA2DS2-VASc Score and Left Atrial Diameter on Atrial Fibrillation in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT06359873
- Acronym / sponsor ID
- LAD-AF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58,427 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Discovery dataset | – | Diagnostic Test: CHA2DS2-VASc score, C2HEST score, and left atrial diameter (LAD)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%). |
| Internal validation dataset | – | Diagnostic Test: CHA2DS2-VASc score, C2HEST score, and left atrial diameter (LAD)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%). |
| External validation dataset | – | Diagnostic Test: CHA2DS2-VASc score, C2HEST score, and left atrial diameter (LAD)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients under 18 years of age.
- Cases with incomplete or unidentifiable results from extracted data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Discovery dataset, External validation dataset, Internal validation dataset |
Primary outcome
left atrial diameter (LAD)
Time frame: 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
Time frame: 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.
C2HEST score
Time frame: 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)
Time frame: 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.
3 secondary outcomes
Area under the curve (AUC) of LAD and occurrence of AF
Time frame: Statistics were completed after data collection, up to 1 months.
AUC of CHA2DS2-VASc score and occurrence of AF
Time frame: Statistics were completed after data collection, up to 1 months.
AUC of C2HEST score and occurrence of AF
Time frame: Statistics were completed after data collection, up to 1 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: Yes. De-identified electronic medical record (DEMR) data platform of Chongqing Medical University Medical Data Institute, accessible at https://demo.yiducloud.com.cn/pub/#/register.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuehui Yin, MD principal investigator
The Second Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Hypertension,Essential, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left atrial diameter (LAD) (time frame: Data collection was completed after discharge from the hospital, up to 3 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.