NCT06417112Completed
Left Atrial Strain Values as an Early Predictor of Atrial Fibrillation
Can Left Atrial Strain Measurements, and Correlating Changes in Left Atrium Area and Volume Size, be Used as an Early Predictor of Atrial Fibrillation?
Source: ClinicalTrials.gov · Last updated 16 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 72 (actual)
- First submitted
- 12 May 2024
- Start date
- 2 Aug 2023
- Primary completion date
- 7 Feb 2024
- Lead sponsor
- Hywel Dda Health Board
- Diseases
- Atrial fibrillation, High blood pressure
- NCT number
- NCT06417112
What you commit to
- Study type: Observational
- Participants enrolled: 72
- From 2 Aug 2023 to the primary completion date, 7 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Criterion 8: previous cardiac surgery.
Other illness
- Criterion 1: subjects with any valvular pathologies in the control and disease- control groups.
Age
- Criterion 4: subjects \< 50 years old.
Other
- 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 5: poor quality TTE images.
- Criterion 6: inability to provide informed consent.
- Criterion 7: permanent atrial / ventricular pacing.
- Criterion 9: unsatisfactory tracking of the LA endocardial border.
- Criterion 10: patients unwilling to have their results potentially published.
Who the study is looking for
- 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).
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lucy Hwozdyk Coordinator of this site? Confirm its status | Haverfordwest | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.