Atrial Fibrillation (AF)NCT06660849
Atrial Fibrillation Duration and Cortical Lens Opacity
An observational study of Atrial Fibrillation (AF) and Cataract Cortical, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The prevalence of atrial fibrillation (AF) and the risk of stroke increase with a higher CHA2DS2-VASc score. Osmotic stress, which also contributes to cortical cataract formation, increases in the presence of diseases that raise the CHA2DS2-VASc score. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Atrial Fibrillation (AF), Cataract Cortical
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2017to 1 Jun 2024
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study included 400 patients: 200 patients without AF (100 female, 100 male) and 200 patients with AF (100 female, 100 male). The patients\' median age was 70 years. Patients with New York Heart Association class 1, 2, or 3 heart failure (HF) were included, regardless of the cause of HF.
Who may be able to join
- Atrial Fibrillation patients
Who cannot join
- Advanced HF (New York Heart Association class 4), Decompensated HF Prior cataract surgery Diabetic ketoacidosis Alcohol use Severe hyponatremia [sodium level of \< 125 mEq/L], Nephrotic syndrome Cirrhosis Hypothyroidism
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Atatürk Sanatoryum TR Hospital
Ankara, 06530
About this study
Official title: Predicting the Presence and Duration of Atrial Fibrillation From Cortical Lens Opacity
The prevalence of atrial fibrillation (AF) and the risk of stroke increase with a higher CHA2DS2-VASc score. Osmotic stress, which also contributes to cortical cataract formation, increases in the presence of diseases that raise the CHA2DS2-VASc score. Knowledge of AF duration is crucial because it heightens the risk of AF-related complications. This study investigated whether the presence of cortical cataracts, classified using the Lens Opacity Classification System (LOCS)stage, can predict the presence and duration of AF.
Read the detailed description
Atrial fibrillation (AF) is the most common type of heart rhythm disorder encountered in clinical settings and is associated with increased morbidity and mortality. The prevalence of AF and the risk of stroke increase with higher CHA2DS2-VASc scores . Cortical cataracts develop at the periphery of the lens and progress toward the center in a spoke-like pattern. The incidences of AF and cortical cataracts significantly increase with age .
Similar to subclinical AF, the initial onset of AF may go undetected, and the time required for AF to become permanent varies. Longer episodes of AF and higher CHA2DS2-VASc scores are strongly associated with an increased annual risk of stroke or systemic embolism , making it essential to estimate the duration of AF.
Cortical cataract stages can be easily identified and monitored through simple biomicroscopic examination. To our knowledge, no reliable method currently exists to predict the duration of AF of unknown onset. This study investigated the relationship between cortical cataract stages and the presence and duration of AF by analyzing p.osmolarity data and comparing it with the LAVI.
- Conditions
- Atrial Fibrillation (AF), Cataract Cortical
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group 1 ,group 2 | The patients' median age was 70 years. Patients with New York Heart Association class 1, 2, or 3 heart failure (HF) were included, regardless of the cause of HF. Both groups comprised patients with a similar number and duration of comorbidities that contributed to their CHA2DS2-VASc scores. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cortical cataract opacification grading.
All participants underwent detailed eye examinations using a biomicroscope . Digital photographs of the lenses were then captured using a smartphone under retro-illumination. Due to its simplicity, the Lens Opacity Classification System 2 [LOCS 2-Cortical] was used to perform cortical cataract opacification grading.
Measured: day1
LAVI (left atrial volume index)(ml/m2)
LAVI were measured using a GE Vivid N60 echocardiography system
Measured: day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start1 Jul 2017
- Primary completion1 Mar 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Şahbender Koç, Ankara Ataturk Sanatorium Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660849
- Sponsor's protocol ID
- AnkaraAtaturkSTRH
- Status last verified
- Oct 2024
- First submitted
- 24 Sep 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Relationship between cortical cataract stages and the presence and duration of AF
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting the Presence and Duration of Atrial Fibrillation From Cortical Lens Opacity
- ClinicalTrials.gov ID
- NCT06660849
- Acronym / sponsor ID
- AnkaraAtaturkSTRH
- Conditions
- Atrial Fibrillation (AF), Cataract Cortical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research HospitalOther government
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence of atrial fibrillation (AF) and the risk of stroke increase with a higher CHA2DS2-VASc score. Osmotic stress, which also contributes to cortical cataract formation, increases in the presence of diseases that raise the CHA2DS2-VASc score. Knowledge of AF duration is crucial because it heightens the risk of AF-related complications. This study investigated whether the presence of cortical cataracts, classified using the Lens Opacity Classification System (LOCS)stage, can predict the presence and duration of AF.
Detailed description
Atrial fibrillation (AF) is the most common type of heart rhythm disorder encountered in clinical settings and is associated with increased morbidity and mortality. The prevalence of AF and the risk of stroke increase with higher CHA2DS2-VASc scores . Cortical cataracts develop at the periphery of the lens and progress toward the center in a spoke-like pattern. The incidences of AF and cortical cataracts significantly increase with age .
Similar to subclinical AF, the initial onset of AF may go undetected, and the time required for AF to become permanent varies. Longer episodes of AF and higher CHA2DS2-VASc scores are strongly associated with an increased annual risk of stroke or systemic embolism , making it essential to estimate the duration of AF.
Cortical cataract stages can be easily identified and monitored through simple biomicroscopic examination. To our knowledge, no reliable method currently exists to predict the duration of AF of unknown onset. This study investigated the relationship between cortical cataract stages and the presence and duration of AF by analyzing p.osmolarity data and comparing it with the LAVI.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group 1 ,group 2 | – | –The patients' median age was 70 years. Patients with New York Heart Association class 1, 2, or 3 heart failure (HF) were included, regardless of the cause of HF. Both groups comprised patients with a similar number and duration of comorbidities that contributed to their CHA2DS2-VASc scores. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study included 400 patients: 200 patients without AF (100 female, 100 male) and 200 patients with AF (100 female, 100 male). The patients\' median age was 70 years. Patients with New York Heart Association class 1, 2, or 3 heart failure (HF) were included, regardless of the cause of HF.
Key inclusion criteria (1 listed)
- Atrial Fibrillation patients
Key exclusion criteria (1 listed)
- Advanced HF (New York Heart Association class 4), Decompensated HF Prior cataract surgery Diabetic ketoacidosis Alcohol use Severe hyponatremia [sodium level of \< 125 mEq/L], Nephrotic syndrome Cirrhosis Hypothyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cortical cataract opacification grading.
Time frame: day1
All participants underwent detailed eye examinations using a biomicroscope . Digital photographs of the lenses were then captured using a smartphone under retro-illumination. Due to its simplicity, the Lens Opacity Classification System 2 [LOCS 2-Cortical] was used to perform cortical cataract opacification grading.
LAVI (left atrial volume index)(ml/m2)
Time frame: day1
LAVI were measured using a GE Vivid N60 echocardiography system
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Individual participant dataSharing planned: Yes. Relationship between cortical cataract stages and the presence and duration of AF
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF) and Cataract Cortical, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cortical cataract opacification grading. (time frame: day1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.