Left Atrial Strain Values as an Early Predictor of Atrial Fibrillation

NCT06417112 | Completed

• 1 other identifier: 324893
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Atrial Fibrillation; Hypertension

Keywords

atrial fibrillation; hypertension; LA size; LA strain; LA reservoir strain; LA conduit strain; LA contractile strain

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline

• LA volume size

  Taking measurements to assess left atrial volume from two different views (A4C \& A2C) as well as biplane measurements.

  Baseline

• LA area size

  Taking measurements to assess left atrial area from A4C view.

  Baseline

Study Arms (3)

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

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

Known atrial fibrillation

All participants are known to have a history of atrial fibrillation (paroxysmal, persistent or permanent).

Diagnostic Test: Transthoracic Echocardiogram

Interventions

Transthoracic Echocardiogram DIAGNOSTIC_TEST

All participants have been referred for a transthoracic echocardiogram by a clinician.

Known atrial fibrillation; Normal sinus rhythm and hypertensive; Normal sinus rhythm and normotensive

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hywel Dda Health Board: lead

Study Sites (1)

Lucy Hwozdyk

Haverfordwest, Pembrokeshire, SA61 2PZ, United Kingdom

Location

Related Publications (31)

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Related Links

• Incremental value of left atrial strain to predict atrial fibrillation recurrence after cryoballoon ablation

MeSH Terms

Conditions

Atrial Fibrillation; Hypertension

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Lucy Hwozdyk

  Hywel Dda University Health Board

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee Clinical Cardiac Scientist

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: May 16, 2024
• Study Start: August 2, 2023
• Primary Completion: February 7, 2024
• Study Completion: April 30, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

GB (1)