Atrial FibrillationNCT06417112
Left Atrial Strain Values as an Early Predictor of Atrial Fibrillation
An observational study of Atrial Fibrillation and Hypertension, run by Hywel Dda Health Board at 1 site in United Kingdom.
Trial summary
Atrial fibrillation (AF) is the most common type of abnormal heart rhythm. This occurs as the chambers of the heart pump irregularly, often resulting in a fast heart rate and symptoms of irregular pounding and fluttering. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Atrial Fibrillation, Hypertension
- What is being tested?
- Transthoracic Echocardiogram
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Aug 2023to 30 Apr 2024
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: To be included, patients had to be categorised into one of the following categories: normal sinus rhythm and normotensive, normal sinus rhythm and hypertensive, or known chronic atrial fibrillation. Additionally, all eligible patients had to conform to the aforementioned inclusion and exclusion criteria.
Who may be able to join
- Criterion 1: subjects will be included in the study if they are within one of the following groups:
- Known to be in normal sinus rhythm, are normotensive and have no underlying health problems.
- Known to be in normal sinus rhythm and have controlled hypertension. This must have been diagnosed by a healthcare professional and the patient should be taking appropriate antihypertensive medication.
- Known to have chronic atrial fibrillation (persistent or permanent AF). This must have been diagnosed by a healthcare professional and the patient should be appropriately anticoagulated.
- Criterion 2: subjects should ideally be ≥ 50 years, but subjects will be age matched across all three groups.
- Criterion 3: patients should have an EF ≥ 50%.
- Criterion 4: good quality TTE images.
- Criterion 5: No valvular pathologies. o Patients with AF that have < moderate valvular pathologies may be considered (as per the British Society of Echocardiography Guidelines).
Who cannot join
- Criterion 1: subjects with any valvular pathologies in the control and disease- control groups.
- Criterion 2: subjects with AF that have ≥ moderate valvular pathologies (as per the British Society of Echocardiography Guidelines).
- Criterion 3: subjects with an EF < 50%.
- Criterion 4: subjects < 50 years old.
- Criterion 5: poor quality TTE images.
- Criterion 6: inability to provide informed consent.
Show all 10Show fewer
- Criterion 7: permanent atrial / ventricular pacing.
- Criterion 8: previous cardiac surgery.
- Criterion 9: unsatisfactory tracking of the LA endocardial border.
- Criterion 10: patients unwilling to have their results potentially published.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Lucy Hwozdyk
Haverfordwest, Pembrokeshire, SA61 2PZ
About this study
Official title: Can Left Atrial Strain Measurements, and Correlating Changes in Left Atrium Area and Volume Size, be Used as an Early Predictor of Atrial Fibrillation?
Atrial fibrillation (AF) is the most common type of abnormal heart rhythm. This occurs as the chambers of the heart pump irregularly, often resulting in a fast heart rate and symptoms of irregular pounding and fluttering. There are many risk factors predisposing to AF, however, the cause cannot always be easily determined. Additionally, not all AF patients experience symptoms and consequently, this abnormal rhythm may go undetected and may be discovered accidentally. This is detrimental to patients, as untreated AF patients are at an increased risk of stroke.
Patients that are suspected of having AF are referred for an ultrasound scan of the heart (echocardiogram). It is expected to see structural changes to the heart's chambers. However, structural and electrical changes of the heart may be the cause of AF but may also be a result of AF, resulting in a chicken and egg situation. It may be possible that a different type of measurement can be used during an echocardiogram to detect subtle changes in heart muscle patterns. This measurement may then serve to be an early predictor of AF. This would be determined by comparing the patterns in patients with a normal, regular rhythm to those with AF.
Potential candidates are initially screened based on their echocardiogram referral. If deemed suitable for this study, the study process is explained to the patient and written informed consent is invited and received. The echocardiogram will be performed as normal with a focus on the area and volume measurements taken of one of the top chambers of the heart. An additional measurement will be taken to observe any subtle changes in the arrangement of heart cells within this same heart chamber. These measurements can be compared to each other to establish any relationship as well as compared to patients with and without AF.
Read the detailed description
Atrial fibrillation (AF) is the most prevalent type of arrhythmia within an adult population and is characterised by disorganised, chaotic, electrical activity and thus, ineffective atrial contraction causing irregular ventricular contraction. AF can be categorised into three different groups: paroxysmal, persistent and permanent. The prevalence of AF increases with age and is associated with a range of risk factors including: hypertension, obesity and alcohol consumption. There is a plethora of both cardiac and non-cardiac causes of AF and the cause is not always clear for each patient. Furthermore, causes of AF can also present as the by-product of AF, this increases the difficulty in determining the individual patient's cause of onset. A diagnosis of AF can be incidental as not all patients are symptomatic. If AF goes undetected, this puts the patient at an increased risk of blood clot formation and stroke.
Patients suspected of having AF are routinely referred for a transthoracic echocardiogram (TTE). It is common for AF patients to have a dilated left atrium (LA). This can be visually confirmed, and the LA area and volume can be measured during a TTE. LA strain measurements are not routinely measured during TTEs but may be able to detect subtle changes in longitudinal strain patterns of the myocardium. By comparing the strain patterns in patients with normal sinus rhythm (control) to those with AF, a scale can be created to suggest and predict whether a patient is likely to develop AF in the future based on these subtle changes before any changes in LA size occur. Furthermore, this can then be further developed to determine whether there are any significant differences in strain patterns between the three AF groups.
Objectives:
To determine whether there is a significant difference in atrial strain values between patients that are in normal sinus rhythm (NSR, control group) to patients that are known to have atrial fibrillation (disease group). A disease-control group of controlled hypertensive patients in NSR will also be utilised as hypertension is a known risk factor for atrial fibrillation.
Providing that there is a significant difference in the values between NSR and AF patients, a further comparison will be conducted on patients in different type of AF: paroxysmal AF, persistent AF and permanent AF to determine if there is a deterioration in atrial strain values within AF patients.
Left atrial area and volume size will also be measured in all patients and this can then be compared to atrial strain values.
- Conditions
- Atrial Fibrillation, Hypertension
- Being tested
- Transthoracic Echocardiogram
- Keywords
- atrial fibrillation, hypertension, LA size, LA strain, LA reservoir strain, LA conduit strain, LA contractile strain
- Medical subject headings
- Atrial Fibrillation, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic EchocardiogramDiagnostic test
All participants have been referred for a transthoracic echocardiogram by a clinician.
| Study group | Role | What they receive |
|---|---|---|
| Normal sinus rhythm and normotensive | All participants are in normal sinus rhythm at the time of the transthoracic echocardiogram and no previous history of atrial fibrillation.
All participants have blood pressure measurements within normal limits and are not prescribed anti-hypertensive medication. Receives: Diagnostic Test: Transthoracic Echocardiogram | |
| Normal sinus rhythm and hypertensive | All participants are in normal sinus rhythm at the time of the transthoracic echocardiogram and no previous history of atrial fibrillation.
All participants are known to have raised blood pressure measurements previously and are receiving anti-hypertensive medication. Receives: Diagnostic Test: Transthoracic Echocardiogram | |
| Known atrial fibrillation | All participants are known to have a history of atrial fibrillation (paroxysmal, persistent or permanent). Receives: Diagnostic Test: Transthoracic Echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left atrial strain values
Taking measurements to assess left atrial strain from two different views (A4C \& A2C) as well as biplane measurements for reservoir, contractile and conduit LA strain.
Measured: Baseline
LA volume size
Taking measurements to assess left atrial volume from two different views (A4C \& A2C) as well as biplane measurements.
Measured: Baseline
LA area size
Taking measurements to assess left atrial area from A4C view.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start2 Aug 2023
- Primary completion7 Feb 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hywel Dda Health Board
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucy Hwozdyk, Hywel Dda Health Board
- Investigators
- Lucy Hwozdyk, Principal investigator, Hywel Dda University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417112
- Sponsor's protocol ID
- 324893
- Status last verified
- May 2024
- First submitted
- 12 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All participant data has been pseudo-anonymised, this prevents any information from being able to be used to trace back to individual participants. Anonymised data may be able to be shared with other researchers rather than the mean data used in the data analyses.
Publications
Alhakak AS, Biering-Sorensen SR, Mogelvang R, Modin D, Jensen GB, Schnohr P, Iversen AZ, Svendsen JH, Jespersen T, Gislason G, Biering-Sorensen T. Usefulness of left atrial strain for predicting incident atrial fibrillation and ischaemic stroke in the general population. Eur Heart J Cardiovasc Imaging. 2022 Feb 22;23(3):363-371. doi: 10.1093/ehjci/jeaa287.
PubMed 33175146Beyls C, Hermida A, Bohbot Y, Martin N, Viart C, Boisgard S, Daumin C, Huette P, Dupont H, Abou-Arab O, Mahjoub Y. Automated left atrial strain analysis for predicting atrial fibrillation in severe COVID-19 pneumonia: a prospective study. Ann Intensive Care. 2021 Dec 7;11(1):168. doi: 10.1186/s13613-021-00955-w.
PubMed 34874509Choi HM, Yoon YE, Oh IY, Cho Y, Cho GY. Global Left Atrial Strain as a Predictor of Silent Atrial Fibrillation Following Dual Chamber Cardiac Implantable Electronic Device Implantation. JACC Cardiovasc Imaging. 2018 Oct;11(10):1537-1539. doi: 10.1016/j.jcmg.2017.12.013. Epub 2018 Feb 14. No abstract available.
PubMed 29454782Gan GCH, Ferkh A, Boyd A, Thomas L. Left atrial function: evaluation by strain analysis. Cardiovasc Diagn Ther. 2018 Feb;8(1):29-46. doi: 10.21037/cdt.2017.06.08.
PubMed 29541609Guo C, Liu J, Zhao S, Teng Y, Shen L. Decreased left atrial strain parameters are correlated with prolonged total atrial conduction time in lone atrial fibrillation. Int J Cardiovasc Imaging. 2016 Jul;32(7):1053-61. doi: 10.1007/s10554-016-0875-3. Epub 2016 Apr 13.
PubMed 27076225Hauser R, Nielsen AB, Skaarup KG, Lassen MCH, Duus LS, Johansen ND, Sengelov M, Marott JL, Jensen G, Schnohr P, Sogaard P, Mogelvang R, Biering-Sorensen T. Left atrial strain predicts incident atrial fibrillation in the general population: the Copenhagen City Heart Study. Eur Heart J Cardiovasc Imaging. 2021 Dec 18;23(1):52-60. doi: 10.1093/ehjci/jeab202.
PubMed 34632488Her AY, Kim JY, Kim YH, Choi EY, Min PK, Yoon YW, Lee BK, Hong BK, Rim SJ, Kwon HM. Left atrial strain assessed by speckle tracking imaging is related to new-onset atrial fibrillation after coronary artery bypass grafting. Can J Cardiol. 2013 Mar;29(3):377-83. doi: 10.1016/j.cjca.2012.06.006. Epub 2012 Aug 15.
PubMed 22902158Hsu PC, Lee WH, Chu CY, Lee HH, Lee CS, Yen HW, Lin TH, Voon WC, Lai WT, Sheu SH, Su HM. Prognostic role of left atrial strain and its combination index with transmitral E-wave velocity in patients with atrial fibrillation. Sci Rep. 2016 Feb 1;6:17318. doi: 10.1038/srep17318.
PubMed 26833057Jarasunas J, Aidietis A, Aidietiene S. Left atrial strain - an early marker of left ventricular diastolic dysfunction in patients with hypertension and paroxysmal atrial fibrillation. Cardiovasc Ultrasound. 2018 Oct 31;16(1):29. doi: 10.1186/s12947-018-0147-6.
PubMed 30382851Ma XX, Zhang YL, Hu B, Zhu MR, Jiang WJ, Wang M, Zheng DY, Xue XP. The usefulness of global left atrial strain for predicting atrial fibrillation recurrence after catheter ablation in patients with persistent and paroxysmal atrial fibrillation. Arch Cardiovasc Dis. 2017 Aug-Sep;110(8-9):447-455. doi: 10.1016/j.acvd.2016.11.005. Epub 2017 May 18.
PubMed 28528995Markides V, Schilling RJ. Atrial fibrillation: classification, pathophysiology, mechanisms and drug treatment. Heart. 2003 Aug;89(8):939-43. doi: 10.1136/heart.89.8.939. No abstract available.
PubMed 12860883Mochizuki A, Yuda S, Fujito T, Kawamukai M, Muranaka A, Nagahara D, Shimoshige S, Hashimoto A, Miura T. Left atrial strain assessed by three-dimensional speckle tracking echocardiography predicts atrial fibrillation recurrence after catheter ablation in patients with paroxysmal atrial fibrillation. J Echocardiogr. 2017 Jun;15(2):79-87. doi: 10.1007/s12574-017-0329-5. Epub 2017 Feb 2.
PubMed 28155065Motoki H, Negishi K, Kusunose K, Popovic ZB, Bhargava M, Wazni OM, Saliba WI, Chung MK, Marwick TH, Klein AL. Global left atrial strain in the prediction of sinus rhythm maintenance after catheter ablation for atrial fibrillation. J Am Soc Echocardiogr. 2014 Nov;27(11):1184-92. doi: 10.1016/j.echo.2014.08.017. Epub 2014 Sep 23.
PubMed 25260436Olsen FJ, Christensen LM, Krieger DW, Hojberg S, Host N, Karlsen FM, Svendsen JH, Christensen H, Biering-Sorensen T. Relationship between left atrial strain, diastolic dysfunction and subclinical atrial fibrillation in patients with cryptogenic stroke: the SURPRISE echo substudy. Int J Cardiovasc Imaging. 2020 Jan;36(1):79-89. doi: 10.1007/s10554-019-01700-y. Epub 2019 Oct 8.
PubMed 31595399Pagola J, Juega J, Francisco-Pascual J, Bustamante A, Penalba A, Pala E, Rodriguez M, De Lera-Alfonso M, Arenillas JF, Cabezas JA, Moniche F, de Torres R, Montaner J, Gonzalez-Alujas T, Alvarez-Sabin J, Molina CA; Crypto-AF study group. Predicting Atrial Fibrillation with High Risk of Embolization with Atrial Strain and NT-proBNP. Transl Stroke Res. 2021 Oct;12(5):735-741. doi: 10.1007/s12975-020-00873-2. Epub 2020 Nov 13.
PubMed 33184686
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Left Atrial Strain Measurements, and Correlating Changes in Left Atrium Area and Volume Size, be Used as an Early Predictor of Atrial Fibrillation?
- ClinicalTrials.gov ID
- NCT06417112
- Acronym / sponsor ID
- 324893
- Conditions
- Atrial Fibrillation, Hypertension
- Keywords
- atrial fibrillation, hypertension, LA size, LA strain, LA reservoir strain, LA conduit strain, LA contractile strain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hywel Dda Health BoardUniversity, hospital or other
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 7 Feb 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 16 May 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.
Atrial fibrillation (AF) is the most common type of abnormal heart rhythm. This occurs as the chambers of the heart pump irregularly, often resulting in a fast heart rate and symptoms of irregular pounding and fluttering. There are many risk factors predisposing to AF, however, the cause cannot always be easily determined. Additionally, not all AF patients experience symptoms and consequently, this abnormal rhythm may go undetected and may be discovered accidentally. This is detrimental to patients, as untreated AF patients are at an increased risk of stroke.
Patients that are suspected of having AF are referred for an ultrasound scan of the heart (echocardiogram). It is expected to see structural changes to the heart's chambers. However, structural and electrical changes of the heart may be the cause of AF but may also be a result of AF, resulting in a chicken and egg situation. It may be possible that a different type of measurement can be used during an echocardiogram to detect subtle changes in heart muscle patterns. This measurement may then serve to be an early predictor of AF. This would be determined by comparing the patterns in patients with a normal, regular rhythm to those with AF.
Potential candidates are initially screened based on their echocardiogram referral. If deemed suitable for this study, the study process is explained to the patient and written informed consent is invited and received. The echocardiogram will be performed as normal with a focus on the area and volume measurements taken of one of the top chambers of the heart. An additional measurement will be taken to observe any subtle changes in the arrangement of heart cells within this same heart chamber. These measurements can be compared to each other to establish any relationship as well as compared to patients with and without AF.
Detailed description
Atrial fibrillation (AF) is the most prevalent type of arrhythmia within an adult population and is characterised by disorganised, chaotic, electrical activity and thus, ineffective atrial contraction causing irregular ventricular contraction. AF can be categorised into three different groups: paroxysmal, persistent and permanent. The prevalence of AF increases with age and is associated with a range of risk factors including: hypertension, obesity and alcohol consumption. There is a plethora of both cardiac and non-cardiac causes of AF and the cause is not always clear for each patient. Furthermore, causes of AF can also present as the by-product of AF, this increases the difficulty in determining the individual patient's cause of onset. A diagnosis of AF can be incidental as not all patients are symptomatic. If AF goes undetected, this puts the patient at an increased risk of blood clot formation and stroke.
Patients suspected of having AF are routinely referred for a transthoracic echocardiogram (TTE). It is common for AF patients to have a dilated left atrium (LA). This can be visually confirmed, and the LA area and volume can be measured during a TTE. LA strain measurements are not routinely measured during TTEs but may be able to detect subtle changes in longitudinal strain patterns of the myocardium. By comparing the strain patterns in patients with normal sinus rhythm (control) to those with AF, a scale can be created to suggest and predict whether a patient is likely to develop AF in the future based on these subtle changes before any changes in LA size occur. Furthermore, this can then be further developed to determine whether there are any significant differences in strain patterns between the three AF groups.
Objectives:
To determine whether there is a significant difference in atrial strain values between patients that are in normal sinus rhythm (NSR, control group) to patients that are known to have atrial fibrillation (disease group). A disease-control group of controlled hypertensive patients in NSR will also be utilised as hypertension is a known risk factor for atrial fibrillation.
Providing that there is a significant difference in the values between NSR and AF patients, a further comparison will be conducted on patients in different type of AF: paroxysmal AF, persistent AF and permanent AF to determine if there is a deterioration in atrial strain values within AF patients.
Left atrial area and volume size will also be measured in all patients and this can then be compared to atrial strain values.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal sinus rhythm and normotensive | – | Diagnostic Test: Transthoracic EchocardiogramAll participants are in normal sinus rhythm at the time of the transthoracic echocardiogram and no previous history of atrial fibrillation. All participants have blood pressure measurements within normal limits and are not prescribed anti-hypertensive medication. |
| Normal sinus rhythm and hypertensive | – | Diagnostic Test: Transthoracic EchocardiogramAll participants are in normal sinus rhythm at the time of the transthoracic echocardiogram and no previous history of atrial fibrillation. All participants are known to have raised blood pressure measurements previously and are receiving anti-hypertensive medication. |
| Known atrial fibrillation | – | Diagnostic Test: Transthoracic EchocardiogramAll participants are known to have a history of atrial fibrillation (paroxysmal, persistent or permanent). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- To be included, patients had to be categorised into one of the following categories: normal sinus rhythm and normotensive, normal sinus rhythm and hypertensive, or known chronic atrial fibrillation. Additionally, all eligible patients had to conform to the aforementioned inclusion and exclusion criteria.
Key inclusion criteria (8 listed)
- Criterion 1: subjects will be included in the study if they are within one of the following groups:
- Criterion 2: subjects should ideally be ≥ 50 years, but subjects will be age matched across all three groups.
- Criterion 3: patients should have an EF ≥ 50%.
- Criterion 4: good quality TTE images.
- Criterion 5: No valvular pathologies. o Patients with AF that have < moderate valvular pathologies may be considered (as per the British Society of Echocardiography Guidelines).
Key exclusion criteria (10 listed)
- Criterion 1: subjects with any valvular pathologies in the control and disease- control groups.
- Criterion 2: subjects with AF that have ≥ moderate valvular pathologies (as per the British Society of Echocardiography Guidelines).
- Criterion 3: subjects with an EF < 50%.
- Criterion 4: subjects < 50 years old.
- Criterion 5: poor quality TTE images.
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 |
|---|---|---|
| Transthoracic EchocardiogramAll participants have been referred for a transthoracic echocardiogram by a clinician. | Diagnostic test | Known atrial fibrillation, Normal sinus rhythm and hypertensive, Normal sinus rhythm and normotensive |
Primary outcome
Left atrial strain values
Time frame: Baseline
Taking measurements to assess left atrial strain from two different views (A4C \& A2C) as well as biplane measurements for reservoir, contractile and conduit LA strain.
LA volume size
Time frame: Baseline
Taking measurements to assess left atrial volume from two different views (A4C \& A2C) as well as biplane measurements.
LA area size
Time frame: Baseline
Taking measurements to assess left atrial area from A4C view.
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 16 May 2024.
- Results publication: PubMed 33175146Alhakak AS, Biering-Sorensen SR, Mogelvang R, Modin D, Jensen GB, Schnohr P, Iversen AZ, Svendsen JH, Jespersen T, Gislason G, Biering-Sorensen T. Usefulness of left atrial strain for predicting incident atrial fibrillation and ischaemic stroke in the general population. Eur Heart J Cardiovasc Imaging. 2022 Feb 22;23(3):363-371. doi: 10.1093/ehjci/jeaa287.
- Results publication: PubMed 34874509Beyls C, Hermida A, Bohbot Y, Martin N, Viart C, Boisgard S, Daumin C, Huette P, Dupont H, Abou-Arab O, Mahjoub Y. Automated left atrial strain analysis for predicting atrial fibrillation in severe COVID-19 pneumonia: a prospective study. Ann Intensive Care. 2021 Dec 7;11(1):168. doi: 10.1186/s13613-021-00955-w.
- Results publication: PubMed 29454782Choi HM, Yoon YE, Oh IY, Cho Y, Cho GY. Global Left Atrial Strain as a Predictor of Silent Atrial Fibrillation Following Dual Chamber Cardiac Implantable Electronic Device Implantation. JACC Cardiovasc Imaging. 2018 Oct;11(10):1537-1539. doi: 10.1016/j.jcmg.2017.12.013. Epub 2018 Feb 14. No abstract available.
- Results publication: PubMed 29541609Gan GCH, Ferkh A, Boyd A, Thomas L. Left atrial function: evaluation by strain analysis. Cardiovasc Diagn Ther. 2018 Feb;8(1):29-46. doi: 10.21037/cdt.2017.06.08.
- Results publication: PubMed 27076225Guo C, Liu J, Zhao S, Teng Y, Shen L. Decreased left atrial strain parameters are correlated with prolonged total atrial conduction time in lone atrial fibrillation. Int J Cardiovasc Imaging. 2016 Jul;32(7):1053-61. doi: 10.1007/s10554-016-0875-3. Epub 2016 Apr 13.
- Results publication: PubMed 34632488Hauser R, Nielsen AB, Skaarup KG, Lassen MCH, Duus LS, Johansen ND, Sengelov M, Marott JL, Jensen G, Schnohr P, Sogaard P, Mogelvang R, Biering-Sorensen T. Left atrial strain predicts incident atrial fibrillation in the general population: the Copenhagen City Heart Study. Eur Heart J Cardiovasc Imaging. 2021 Dec 18;23(1):52-60. doi: 10.1093/ehjci/jeab202.
- Results publication: PubMed 22902158Her AY, Kim JY, Kim YH, Choi EY, Min PK, Yoon YW, Lee BK, Hong BK, Rim SJ, Kwon HM. Left atrial strain assessed by speckle tracking imaging is related to new-onset atrial fibrillation after coronary artery bypass grafting. Can J Cardiol. 2013 Mar;29(3):377-83. doi: 10.1016/j.cjca.2012.06.006. Epub 2012 Aug 15.
- Results publication: PubMed 26833057Hsu PC, Lee WH, Chu CY, Lee HH, Lee CS, Yen HW, Lin TH, Voon WC, Lai WT, Sheu SH, Su HM. Prognostic role of left atrial strain and its combination index with transmitral E-wave velocity in patients with atrial fibrillation. Sci Rep. 2016 Feb 1;6:17318. doi: 10.1038/srep17318.
- Results publication: PubMed 30382851Jarasunas J, Aidietis A, Aidietiene S. Left atrial strain - an early marker of left ventricular diastolic dysfunction in patients with hypertension and paroxysmal atrial fibrillation. Cardiovasc Ultrasound. 2018 Oct 31;16(1):29. doi: 10.1186/s12947-018-0147-6.
- Results publication: PubMed 28528995Ma XX, Zhang YL, Hu B, Zhu MR, Jiang WJ, Wang M, Zheng DY, Xue XP. The usefulness of global left atrial strain for predicting atrial fibrillation recurrence after catheter ablation in patients with persistent and paroxysmal atrial fibrillation. Arch Cardiovasc Dis. 2017 Aug-Sep;110(8-9):447-455. doi: 10.1016/j.acvd.2016.11.005. Epub 2017 May 18.
- Results publication: PubMed 12860883Markides V, Schilling RJ. Atrial fibrillation: classification, pathophysiology, mechanisms and drug treatment. Heart. 2003 Aug;89(8):939-43. doi: 10.1136/heart.89.8.939. No abstract available.
- Results publication: PubMed 28155065Mochizuki A, Yuda S, Fujito T, Kawamukai M, Muranaka A, Nagahara D, Shimoshige S, Hashimoto A, Miura T. Left atrial strain assessed by three-dimensional speckle tracking echocardiography predicts atrial fibrillation recurrence after catheter ablation in patients with paroxysmal atrial fibrillation. J Echocardiogr. 2017 Jun;15(2):79-87. doi: 10.1007/s12574-017-0329-5. Epub 2017 Feb 2.
- Incremental value of left atrial strain to predict atrial fibrillation recurrence after cryoballoon ablationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. All participant data has been pseudo-anonymised, this prevents any information from being able to be used to trace back to individual participants. Anonymised data may be able to be shared with other researchers rather than the mean data used in the data analyses.
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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.
Lucy Hwozdyk principal investigator
Hywel Dda University Health Board
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, run by Hywel Dda Health Board at 1 site in United Kingdom.
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 8 inclusion and 10 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 16 May 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 United Kingdom. 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 strain values (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06417112, which also lists 31 linked publications.
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 16 May 2024.