Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417112
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2024-05-12
Brief Title:
Left Atrial Strain Values as an Early Predictor of Atrial Fibrillation
Sponsor:
Hywel Dda Health Board
Organization:
Hywel Dda Health Board
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 hearts 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
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 hearts 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 patients 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None