Left Atrial Strain Values as an Early Predictor of Atrial Fibrillation

May 12, 2024 updated by: Lucy Hwozdyk, Hywel Dda Health Board

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Pembrokeshire
      • Haverfordwest, Pembrokeshire, United Kingdom, SA61 2PZ
        • Lucy Hwozdyk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: Transthoracic Echocardiogram
All participants have been referred for a transthoracic echocardiogram by a clinician.
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.
Diagnostic test: Transthoracic Echocardiogram
All participants have been referred for a transthoracic echocardiogram by a clinician.
Known atrial fibrillation
All participants are known to have a history of atrial fibrillation (paroxysmal, persistent or permanent).
Diagnostic test: Transthoracic Echocardiogram
All participants have been referred for a transthoracic echocardiogram by a clinician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
LA volume size
Time Frame: Baseline
Taking measurements to assess left atrial volume from two different views (A4C & A2C) as well as biplane measurements.
Baseline
LA area size
Time Frame: Baseline
Taking measurements to assess left atrial area from A4C view.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hywel Dda Health Board

Investigators

  • Principal Investigator: Lucy Hwozdyk, Hywel Dda University Health Board

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2023

Primary Completion (Actual)

February 7, 2024

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

May 12, 2024

First Submitted That Met QC Criteria

May 12, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 12, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 324893

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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