## Protocol Section
### Identification Module
**NCT ID:** NCT06417112

**Brief Title:** Left Atrial Strain Values as an Early Predictor of Atrial Fibrillation

**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?

#### Organization Study ID Info
**ID:** 324893
#### Organization
**Class:** OTHER
**Full Name:** Hywel Dda Health Board
### Status Module
#### Completion Date
**Date:** 2024-04-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-02-07

**Type:** ACTUAL

#### Start Date
**Date:** 2023-08-02

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hywel Dda Health Board

#### Responsible Party

**Investigator Affiliation:** Hywel Dda Health Board

**Investigator Full Name:** Lucy Hwozdyk

**Investigator Title:** Trainee Clinical Cardiac Scientist

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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 Module

**Conditions:**

- Atrial Fibrillation

- Hypertension

**Keywords:**

- atrial fibrillation

- hypertension

- LA size

- LA strain

- LA reservoir strain

- LA conduit strain

- LA contractile strain

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 72

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Diagnostic Test: Transthoracic Echocardiogram

**Label:** Normal sinus rhythm and normotensive

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Diagnostic Test: Transthoracic Echocardiogram

**Label:** Normal sinus rhythm and hypertensive

#### Arm Group 3

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

**Intervention Names:**

- Diagnostic Test: Transthoracic Echocardiogram

**Label:** Known atrial fibrillation

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Known atrial fibrillation

- Normal sinus rhythm and hypertensive

- Normal sinus rhythm and normotensive

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

**Name:** Transthoracic Echocardiogram

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Left atrial strain values

**Time Frame:** Baseline

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

**Measure:** LA volume size

**Time Frame:** Baseline

**Description:** Taking measurements to assess left atrial area from A4C view.

**Measure:** LA area size

**Time Frame:** Baseline

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 50 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Haverfordwest

**Country:** United Kingdom

**Facility:** Lucy Hwozdyk

**State:** Pembrokeshire

**Zip:** SA61 2PZ

#### Overall Officials

**Official 1:**

**Affiliation:** Hywel Dda University Health Board

**Name:** Lucy Hwozdyk

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**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.

**IPD Sharing:** UNDECIDED

### References Module

#### References

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**PMID:** 33175146

**Citation:** Beyls 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.

**PMID:** 34874509

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**PMID:** 34632488

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**PMID:** 26833057

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**PMID:** 30382851

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**PMID:** 28528995

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**Citation:** Mochizuki 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.

**PMID:** 28155065

**Citation:** Motoki 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.

**PMID:** 25260436

**Citation:** Olsen 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.

**PMID:** 31595399

**Citation:** Pagola 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.

**PMID:** 33184686

**Citation:** Park JJ, Park JH, Hwang IC, Park JB, Cho GY, Marwick TH. Left Atrial Strain as a Predictor of New-Onset Atrial Fibrillation in Patients With Heart Failure. JACC Cardiovasc Imaging. 2020 Oct;13(10):2071-2081. doi: 10.1016/j.jcmg.2020.04.031. Epub 2020 Jul 15.

**PMID:** 32682715

**Citation:** Parwani AS, Morris DA, Blaschke F, Huemer M, Pieske B, Haverkamp W, Boldt LH. Left atrial strain predicts recurrence of atrial arrhythmias after catheter ablation of persistent atrial fibrillation. Open Heart. 2017 Apr 28;4(1):e000572. doi: 10.1136/openhrt-2016-000572. eCollection 2017.

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**Citation:** Pathan F, Sivaraj E, Negishi K, Rafiudeen R, Pathan S, D'Elia N, Galligan J, Neilson S, Fonseca R, Marwick TH. Use of Atrial Strain to Predict Atrial Fibrillation After Cerebral Ischemia. JACC Cardiovasc Imaging. 2018 Nov;11(11):1557-1565. doi: 10.1016/j.jcmg.2017.07.027. Epub 2017 Nov 15.

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**Citation:** Pessoa-Amorim G, Mancio J, Vouga L, Ribeiro J, Gama V, Bettencourt N, Fontes-Carvalho R. Impaired Left Atrial Strain as a Predictor of New-onset Atrial Fibrillation After Aortic Valve Replacement Independently of Left Atrial Size. Rev Esp Cardiol (Engl Ed). 2018 Jun;71(6):466-476. doi: 10.1016/j.rec.2017.10.005. Epub 2017 Nov 14. English, Spanish.

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**Citation:** Shaikh AY, Maan A, Khan UA, Aurigemma GP, Hill JC, Kane JL, Tighe DA, Mick E, McManus DD. Speckle echocardiographic left atrial strain and stiffness index as predictors of maintenance of sinus rhythm after cardioversion for atrial fibrillation: a prospective study. Cardiovasc Ultrasound. 2012 Dec 3;10:48. doi: 10.1186/1476-7120-10-48.

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#### See Also Links

**Label:** Incremental value of left atrial strain to predict atrial fibrillation recurrence after cryoballoon ablation

**URL:** https://researchportal.vub.be/en/publications/incremental-value-of-left-atrial-strain-to-predict-atrial-fibrill

## Document Section

### Large Document Module

#### Large Docs

- Date: 2023-05-17

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 437090

- Type Abbrev: Prot_SAP

- Upload Date: 2024-05-12T17:42

- Date: 2023-05-17

- Filename: ICF_001.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 373691

- Type Abbrev: ICF

- Upload Date: 2024-05-12T17:45

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001145

- Term: Arrhythmias, Cardiac

- ID: D000006331

- Term: Heart Diseases

- ID: D000010335

- Term: Pathologic Processes

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M10024

- Name: Hypertension

- Relevance: HIGH

- As Found: Hypertension

- ID: M4586

- Name: Atrial Fibrillation

- Relevance: HIGH

- As Found: Atrial Fibrillation

- ID: M15974

- Name: Sprains and Strains

- Relevance: HIGH

- As Found: Strain

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4453

- Name: Arrhythmias, Cardiac

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006973

- Term: Hypertension

- ID: D000001281

- Term: Atrial Fibrillation

- ID: D000013180

- Term: Sprains and Strains

### Intervention Browse Module - Browse Branches

- Abbrev: AnAg

- Name: Antihypertensive Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4277

- Name: Antihypertensive Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
