AgingNCT04362215
Heart Aging When Near Vision Difficulty Begins
An observational study of Aging, run by Kecioren Education and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Near vision deterioration during aging results from a decrease in accomodation amplitude (AA). Myocardial regeneration is limited, and cardiac aging is an independent risk factor for cardiovascular disease. Thus, the investigators investigated the association between cardiac aging and AA. Read more about this study
- Who is it for?
- Ages 49 to 51 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Subjective accomodation amplitude measurement
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2019to 15 Mar 2020
- How long will I take part?
- 1 Day
- 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 49 to 51 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy Volunteers ,mean 50 years of age (49-51)
Who may be able to join
- Healthy Volunteers, mean 50 years of age (49-51)
Who cannot join
- Hypertension, Diabetes mellitus, Atrial fibrillation, Coronary artery disease, Arrhythmia, Hyperthyroidism , Anemia, Heart failure, Respiratory diseases, Severe obesity (body mass index ≥35 kg/m2),
Trial locations and contacts
1 site in 1 country.
About this study
Near vision deterioration during aging results from a decrease in accomodation amplitude (AA). Myocardial regeneration is limited, and cardiac aging is an independent risk factor for cardiovascular disease. Thus, the investigators investigated the association between cardiac aging and AA.
The subjects (500, mean 50-year-old subjects, with equal males and females) were divided into two groups according to AA measured with a Raf ruler. Biomicroscopy was used to capture images of the lens nucleus in the unaccommodated state, followed by images of a 4 diopter (D) accommodated state. The nucleus diameter change at 1 D accomodation was measured using ImageJ. Cardiac conduction system differences were evaluated using electrocardiography, and cardiac autonomic aging was assessed based on heart rate variability. Myocardial aging was assessed based on diastolic dysfunction.
Read the detailed description
Lens cells and proteins are encapsulated, and they are not turned over or replaced.The lens nucleus starts to form before birth, so the nucleus is one of the three oldest tissues in the body .With aging, continuous cardiomyocyte stress derails proteostasis by causing excessive autophagy and protease activation, and, ultimately, contractile and electrophysiological dysfunction. Aggregate deposition, proteostasis deterioration, and diffusion degradation between the nucleus and cortex are the main reasons for lens aging.Heart, lens, and neuronal cells change significantly with age, and they are older than cells from renewable tissues.
Near vision deterioration during aging results from a decrease in accomodation amplitude (AA). Cardiac aging is an independent risk factor for cardiovascular disease. Thus, the investigators investigated the association between cardiac aging and AA. The subjects (500 mean 50-year-old subjects, with equal males and females) were divided into two groups according to AA measured with a Raf ruler. The nucleus diameter change at 1 D accomodation was measured using ImageJ. Cardiac conduction system differences, autonomic aging, myocardial aging were evaluated using electrocardiography, heart rate variability and diastolic dysfunction. For near distance vision,compared to subjects who could see clearly from 24-28 cm, subjects who could see clearly from 29-33 cm had a 2.104-fold higher risk of a lateral e' velocity <10 cm/s[95%CI; 1.312-3.374], 2.603-fold higher risk of diastolic dysfunction[95%CI; 1.453-4.662], 1.54-fold higher risk of a low/high frequency ratio >3.1, [95%CI;1.085-2.197]. Subjective AA measurement can predict important heart aging parameters.
- Conditions
- Aging
- Being tested
- Subjective accomodation amplitude measurement
- Keywords
- aging, heart aging, presbyopia
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subjective accomodation amplitude measurementDiagnostic test
Also called ECG,Echocardiography,Holter implementation
ECG:Electrocardıography Echocardiography, Holter implementation(for Lf/Hf ratio))
| Study group | Role | What they receive |
|---|---|---|
| High AA group | Group 1 consisted of those having an AA level of 3.57-4.16 D (high AA group; those who had near clear vision between 24-28 cm). . Receives: Diagnostic Test: Subjective accomodation amplitude measurement | |
| Low AA group | Group 2 consisted of those having an AA level of 3.44-3.03 D (low AA group; those who had near clear vision between 29-33 cm) Receives: Diagnostic Test: Subjective accomodation amplitude measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG interval changes meauserements(ms,mm,number)
ECG PR interval (ms),Ventricle Premature Systol(number),Left Ventricle Hypertrophy(mm)Right Bundle Branch,Left Bundle Branch (the presence / absence)
Measured: 1 day
Holter implementation
To detect autonomic cardiac aging based on heart rate variability (HRV),the low frequency (LF)/high frequency (HF) ratio was measured using a CardioScan II (version 11.4.0054a; DMS Software, Stateline, NV, USA)
Measured: 1 day
Echocardiographic measurements
Diastolic dysfunction meauserements(mitral anulus lateral e' velocity <10 cm/s, average E/e' ratio >14, Left atrium maximum volume index (LAv.i.) >34 mL/m2, and peak Tricuspit Regurgitation velocity >2.8 m/s.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start10 Sep 2019
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kecioren Education and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şahbender Koç, Kecioren Education and Training Hospital
- Investigators
- Şahbender Koç, Principal investigator, University of Health Sciences Ankara Keçiören Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362215
- Sponsor's protocol ID
- 09/2019/1953
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
Publications
Koc S, Baysal SS. Heart aging when near vision difficulty begins. Aging Male. 2020 Dec;23(5):1346-1354. doi: 10.1080/13685538.2020.1766438. Epub 2020 May 25.
PubMed 32449445
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Aging When Near Vision Difficulty Begins
- ClinicalTrials.gov ID
- NCT04362215
- Acronym / sponsor ID
- 09/2019/1953
- Conditions
- Aging
- Keywords
- aging, heart aging, presbyopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Kecioren Education and Training HospitalUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 24 Apr 2020 (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.
Near vision deterioration during aging results from a decrease in accomodation amplitude (AA). Myocardial regeneration is limited, and cardiac aging is an independent risk factor for cardiovascular disease. Thus, the investigators investigated the association between cardiac aging and AA.
The subjects (500, mean 50-year-old subjects, with equal males and females) were divided into two groups according to AA measured with a Raf ruler. Biomicroscopy was used to capture images of the lens nucleus in the unaccommodated state, followed by images of a 4 diopter (D) accommodated state. The nucleus diameter change at 1 D accomodation was measured using ImageJ. Cardiac conduction system differences were evaluated using electrocardiography, and cardiac autonomic aging was assessed based on heart rate variability. Myocardial aging was assessed based on diastolic dysfunction.
Detailed description
Lens cells and proteins are encapsulated, and they are not turned over or replaced.The lens nucleus starts to form before birth, so the nucleus is one of the three oldest tissues in the body .With aging, continuous cardiomyocyte stress derails proteostasis by causing excessive autophagy and protease activation, and, ultimately, contractile and electrophysiological dysfunction. Aggregate deposition, proteostasis deterioration, and diffusion degradation between the nucleus and cortex are the main reasons for lens aging.Heart, lens, and neuronal cells change significantly with age, and they are older than cells from renewable tissues.
Near vision deterioration during aging results from a decrease in accomodation amplitude (AA). Cardiac aging is an independent risk factor for cardiovascular disease. Thus, the investigators investigated the association between cardiac aging and AA. The subjects (500 mean 50-year-old subjects, with equal males and females) were divided into two groups according to AA measured with a Raf ruler. The nucleus diameter change at 1 D accomodation was measured using ImageJ. Cardiac conduction system differences, autonomic aging, myocardial aging were evaluated using electrocardiography, heart rate variability and diastolic dysfunction. For near distance vision,compared to subjects who could see clearly from 24-28 cm, subjects who could see clearly from 29-33 cm had a 2.104-fold higher risk of a lateral e' velocity <10 cm/s[95%CI; 1.312-3.374], 2.603-fold higher risk of diastolic dysfunction[95%CI; 1.453-4.662], 1.54-fold higher risk of a low/high frequency ratio >3.1, [95%CI;1.085-2.197]. Subjective AA measurement can predict important heart aging parameters.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High AA group | – | Diagnostic Test: Subjective accomodation amplitude measurementGroup 1 consisted of those having an AA level of 3.57-4.16 D (high AA group; those who had near clear vision between 24-28 cm). . |
| Low AA group | – | Diagnostic Test: Subjective accomodation amplitude measurementGroup 2 consisted of those having an AA level of 3.44-3.03 D (low AA group; those who had near clear vision between 29-33 cm) |
Who may qualify
- Ages
- 49 to 51 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy Volunteers ,mean 50 years of age (49-51)
Key inclusion criteria (1 listed)
- Healthy Volunteers, mean 50 years of age (49-51)
Key exclusion criteria (1 listed)
- Hypertension, Diabetes mellitus, Atrial fibrillation, Coronary artery disease, Arrhythmia, Hyperthyroidism , Anemia, Heart failure, Respiratory diseases, Severe obesity (body mass index ≥35 kg/m2),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subjective accomodation amplitude measurementAlso: ECG,Echocardiography,Holter implementationECG:Electrocardıography Echocardiography, Holter implementation(for Lf/Hf ratio)) | Diagnostic test | High AA group, Low AA group |
Primary outcome
ECG interval changes meauserements(ms,mm,number)
Time frame: 1 day
ECG PR interval (ms),Ventricle Premature Systol(number),Left Ventricle Hypertrophy(mm)Right Bundle Branch,Left Bundle Branch (the presence / absence)
Holter implementation
Time frame: 1 day
To detect autonomic cardiac aging based on heart rate variability (HRV),the low frequency (LF)/high frequency (HF) ratio was measured using a CardioScan II (version 11.4.0054a; DMS Software, Stateline, NV, USA)
Echocardiographic measurements
Time frame: 1 day
Diastolic dysfunction meauserements(mitral anulus lateral e' velocity <10 cm/s, average E/e' ratio >14, Left atrium maximum volume index (LAv.i.) >34 mL/m2, and peak Tricuspit Regurgitation velocity >2.8 m/s.
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 24 Apr 2020.
- Derived from this study: PubMed 32449445Koc S, Baysal SS. Heart aging when near vision difficulty begins. Aging Male. 2020 Dec;23(5):1346-1354. doi: 10.1080/13685538.2020.1766438. Epub 2020 May 25.
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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.
Şahbender Koç principal investigator
University of Health Sciences Ankara Keçiören Education Hospital
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 Aging, run by Kecioren Education and Training 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 24 Apr 2020. 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?
ECG interval changes meauserements(ms,mm,number) (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04362215, which also lists 1 linked publication.
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 24 Apr 2020.