- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06660849
Atrial Fibrillation Duration and Cortical Lens Opacity
Predicting the Presence and Duration of Atrial Fibrillation From Cortical Lens Opacity
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey, 06530
- Ankara Atatürk Sanatoryum TR Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Atrial Fibrillation patients
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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cortical cataract opacification grading.
Time Frame: day1
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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.
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day1
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LAVI (left atrial volume index)(ml/m2)
Time Frame: day1
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LAVI were measured using a GE Vivid N60 echocardiography system
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day1
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AnkaraAtaturkSTRH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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