Smoking ( Cigarette)NCT07427745
SMOKING AND PRESENCE OF FRANK'S SIGN
An observational study of Smoking ( Cigarette) and Cardiovascular Disease, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the effect of cigarette smoking-one of the major risk factors for cardiovascular diseases-on the development of Frank's sign (DELC) was investigated. Rather than smoking status alone, cumulative smoking exposure was considered to cause vascular damage and thereby influence the formation of DELC. Read more about this study
- Who is it for?
- Ages 40 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking ( Cigarette), Cardiovascular Disease
- What is being tested?
- To obtain bilateral ear photographs and To take a medical history
- How many people
- 404 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 6 May 2025
- 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 40 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population consisted of all individuals aged 40-59 years presenting to the clinics of the Department of Family Medicine at Samsun University Faculty of Medicine (Smoking Cessation, Family Medicine, Traditional and Complementary Medicine, Home Health Services, and Obesity Clinics)
Who may be able to join
- Individuals aged 40-59 years who presented to the relevant outpatient clinics were included in the study.
Who cannot join
- The exclusion criteria included being outside the specified age range, the presence of an earring or piercing on the earlobe, a history of trauma affecting the integrity of the ear, the presence of soft tissue diseases, or ear malformations.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun University Training and Research Hospital (Samsun City Hospital)
Samsun
About this study
Official title: PRESENCE OF FRANK'S SIGN: A COMPARATIVE EVALUATION IN SMOKERS AND NON-SMOKERS
In this study, the effect of cigarette smoking-one of the major risk factors for cardiovascular diseases-on the development of Frank's sign (DELC) was investigated. Rather than smoking status alone, cumulative smoking exposure was considered to cause vascular damage and thereby influence the formation of DELC. Consequently, these findings may enable family physicians and other clinicians to approach patients rapidly and non-invasively within the framework of preventive medicine.
- Conditions
- Smoking ( Cigarette), Cardiovascular Disease
- Being tested
- To obtain bilateral ear photographs, To take a medical history
- Keywords
- Frank's sign, smoking, cardiovascular disease
- Medical subject headings
- Cigarette Smoking, Cardiovascular Diseases, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To obtain bilateral ear photographsOther
Digital photographs obtained from both ears in a well-lit environment were evaluated by the study researchers. The presence of Frank's sign and its staging according to the Modified Patel-Lopez classification were confirmed by a positive assessment from at least two researchers
To take a medical historyOther
The participants' sociodemographic data, histories of chronic diseases, medication use, family histories, and smoking habits were recorded by the researchers via face-to-face interviews (average duration: 5 min)
| Study group | Role | What they receive |
|---|---|---|
| smokers | Smoking individuals aged between 40 and 59 years. Receives: Other: To obtain bilateral ear photographs; Other: To take a medical history | |
| non-smokers (control group) | Individuals aged between 40 and 59 years who do not smoke Receives: Other: To obtain bilateral ear photographs; Other: To take a medical history |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the relationship between DELC (diagonal earlobe crease) and smoking consumption
The presence of DELC as unilateral, bilateral, or absent was evaluated with respect to smoking status categorized as current, non-smoker, or former. Categorical variables were presented as counts and percentages. Comparisons between groups were performed using the chi-square test. Differences with p-values < 0.05 were considered statistically significant.
Measured: maximum duration: 10 minutes
Association between smoking and DELC stage in patients with unilateral and bilateral DELC
The presence of unilateral and bilateral DELC in the right and/or left ear was assessed across smoking status groups defined as current, non-smoker, and former. Categorical variables were presented as counts and percentages. Comparisons between groups were performed using the chi-square test. Differences with p-values < 0.05 were considered statistically significant.
Measured: maximum duration: 10 minutes
Secondary outcomes (3)
Relationship between the participants' chronic diseases, medication use, family history, and the presence of DELC (diagonal earlobe crease)
The presence of chronic diseases (hypertension, diabetes, hyperlipidemia, and cardiovascular diseases), obesity, history of angiography, medication use, and family history of cardiovascular diseases and premature death was evaluated in individuals with unilateral and bilateral DELC as well as in those without DELC (absent). Categorical variables were presented as counts and percentages. Comparisons between groups were performed using the chi-square test. Differences with p-values < 0.05 were considered statistically significant.
Measured: maximum duration: 10 minutes
Analysis of the relationship between DELC and the presence of cardiac/noncardiac diseases and medication use
Diseases and medications were categorized as cardiac and non-cardiac. In individuals with unilateral and bilateral DELC, as well as in those without DELC (absent), the presence of cardiac and non-cardiac diseases was first evaluated, followed by the presence of cardiac and non-cardiac medication use.
Categorical variables were presented as counts and percentages. Comparisons between groups were performed using the chi-square test. Differences with p-values < 0.05 were considered statistically significant.
Measured: maximum duration: 10 minutes
Demographic characteristics of the participants
Demographic characteristics like sex, marital status and smoking status of the participants were evaluated
Measured: maximum duration: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Sep 2024
- Primary completion1 Mar 2025
- Study completion6 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Smoking ( Cigarette)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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Onur Öztürk, Study director, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427745
- Sponsor's protocol ID
- 2024/11/1
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I am reluctant to share it because of some ethical considerations.
Publications
Linden OE, He JK, Morrison CS, Sullivan SR, Taylor HOB. The Relationship between Age and Facial Asymmetry. Plast Reconstr Surg. 2018 Nov;142(5):1145-1152. doi: 10.1097/PRS.0000000000004831.
PubMed 30511968Teul IB, Swiniarska B, Flis W, Wronka I. Fluctuating asymmetry of human morphometric features as a marker of developmental instability caused by adverse environmental conditions. Folia Morphol (Warsz). 2024;83(4):893-901. doi: 10.5603/fm.98782. Epub 2024 Mar 21.
PubMed 38512009Schou AL, Molbak ML, Schnor P, Gronbaek M, Tolstrup JS. Alcohol consumption, smoking and development of visible age-related signs: a prospective cohort study. J Epidemiol Community Health. 2017 Dec;71(12):1177-1184. doi: 10.1136/jech-2016-208568.
PubMed 29114032Charlier P, Deo S. Modern diagnosis of Flaubert's death mask. Lancet Neurol. 2017 Jan;16(1):31. doi: 10.1016/S1474-4422(16)30354-4. No abstract available.
PubMed 27979353Doering C, Ruhsenberger C, Phillips DS. Ear lobe creases and heart disease. J Am Geriatr Soc. 1977 Apr;25(4):183-5. doi: 10.1111/j.1532-5415.1977.tb00290.x.
PubMed 845360Lucenteforte E, Romoli M, Zagli G, Gensini GF, Mugelli A, Vannacci A. Ear lobe crease as a marker of coronary artery disease: a meta-analysis. Int J Cardiol. 2014 Jul 15;175(1):171-5. doi: 10.1016/j.ijcard.2014.04.025. Epub 2014 Apr 13. No abstract available.
PubMed 24866080Edston E. The earlobe crease, coronary artery disease, and sudden cardiac death: an autopsy study of 520 individuals. Am J Forensic Med Pathol. 2006 Jun;27(2):129-33. doi: 10.1097/01.paf.0000221067.73173.d7.
PubMed 16738431Christoffersen M, Frikke-Schmidt R, Schnohr P, Jensen GB, Nordestgaard BG, Tybjaerg-Hansen A. Visible age-related signs and risk of ischemic heart disease in the general population: a prospective cohort study. Circulation. 2014 Mar 4;129(9):990-8. doi: 10.1161/CIRCULATIONAHA.113.001696. Epub 2013 Dec 13.
PubMed 24334176Wu XL, Yang DY, Zhao YS, Chai WH, Jin ML. Diagonal earlobe crease and coronary artery disease in a Chinese population. BMC Cardiovasc Disord. 2014 Apr 4;14:43. doi: 10.1186/1471-2261-14-43.
PubMed 24708687Thilo C, Meisinger C, Heier M, von Scheidt W, Kirchberger I. Diagonal earlobe crease and long-term survival after myocardial infarction. BMC Cardiovasc Disord. 2021 Dec 16;21(1):597. doi: 10.1186/s12872-021-02425-4.
PubMed 34915852Prangenberg J, Doberentz E, Johann L, Madea B. The prognostic value of the Frank sign. Forensic Sci Med Pathol. 2022 Jun;18(2):149-155. doi: 10.1007/s12024-022-00463-8. Epub 2022 Feb 18.
PubMed 35179701Oda N, Maruhashi T, Kishimoto S, Kajikawa M, Iwamoto Y, Iwamoto A, Matsui S, Hidaka T, Kihara Y, Chayama K, Goto C, Aibara Y, Nakashima A, Noma K, Hirano H, Higashi Y. Relation of the Bilateral Earlobe Crease to Endothelial Dysfunction. Am J Cardiol. 2017 Jun 15;119(12):1983-1988. doi: 10.1016/j.amjcard.2017.03.029. Epub 2017 Mar 29.
PubMed 28438303Xu J, Wang L, Zhang C, Wang J, Zheng D, Huang Y, Zhang X, You S, Cao Y, Liu CF. The prognostic value of deep earlobe creases in patients with acute ischemic stroke. Front Cardiovasc Med. 2023 May 30;10:1096044. doi: 10.3389/fcvm.2023.1096044. eCollection 2023.
PubMed 37324621Rodriguez-Lopez C, Garlito-Diaz H, Madronero-Mariscal R, Sanchez-Cervilla PJ, Graciani A, Lopez-Sendon JL, Lopez-de-Sa E. Earlobe crease shapes and cardiovascular events. Am J Cardiol. 2015 Jul 15;116(2):286-93. doi: 10.1016/j.amjcard.2015.04.023. Epub 2015 Apr 23.
PubMed 25983126Pasternac A, Sami M. Predictive value of the ear-crease sign in coronary artery disease. Can Med Assoc J. 1982 Mar 15;126(6):645-9.
PubMed 7066824
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRESENCE OF FRANK'S SIGN: A COMPARATIVE EVALUATION IN SMOKERS AND NON-SMOKERS
- ClinicalTrials.gov ID
- NCT07427745
- Acronym / sponsor ID
- 2024/11/1
- Conditions
- Smoking ( Cigarette), Cardiovascular Disease
- Keywords
- Frank's sign, smoking, cardiovascular disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 6 May 2025 (actual)
- First posted
- 23 Feb 2026 (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.
In this study, the effect of cigarette smoking-one of the major risk factors for cardiovascular diseases-on the development of Frank's sign (DELC) was investigated. Rather than smoking status alone, cumulative smoking exposure was considered to cause vascular damage and thereby influence the formation of DELC. Consequently, these findings may enable family physicians and other clinicians to approach patients rapidly and non-invasively within the framework of preventive medicine.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| smokers | – | Other: To obtain bilateral ear photographs, Other: To take a medical historySmoking individuals aged between 40 and 59 years. |
| non-smokers (control group) | – | Other: To obtain bilateral ear photographs, Other: To take a medical historyIndividuals aged between 40 and 59 years who do not smoke |
Who may qualify
- Ages
- 40 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consisted of all individuals aged 40-59 years presenting to the clinics of the Department of Family Medicine at Samsun University Faculty of Medicine (Smoking Cessation, Family Medicine, Traditional and Complementary Medicine, Home Health Services, and Obesity Clinics)
Key inclusion criteria (1 listed)
- Individuals aged 40-59 years who presented to the relevant outpatient clinics were included in the study.
Key exclusion criteria (1 listed)
- The exclusion criteria included being outside the specified age range, the presence of an earring or piercing on the earlobe, a history of trauma affecting the integrity of the ear, the presence of soft tissue diseases, or ear malformations.
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 |
|---|---|---|
| To obtain bilateral ear photographsDigital photographs obtained from both ears in a well-lit environment were evaluated by the study researchers. The presence of Frank's sign and its staging according to the Modified Patel-Lopez classification were confirmed by a positive assessment from at least two researchers | Other | non-smokers (control group), smokers |
| To take a medical historyThe participants' sociodemographic data, histories of chronic diseases, medication use, family histories, and smoking habits were recorded by the researchers via face-to-face interviews (average duration: 5 min) | Other | non-smokers (control group), smokers |
Primary outcome
Analysis of the relationship between DELC (diagonal earlobe crease) and smoking consumption
Time frame: maximum duration: 10 minutes
The presence of DELC as unilateral, bilateral, or absent was evaluated with respect to smoking status categorized as current, non-smoker, or former. Categorical variables were presented as counts and percentages. Comparisons between groups were performed using the chi-square test. Differences with p-values < 0.05 were considered statistically significant.
Association between smoking and DELC stage in patients with unilateral and bilateral DELC
Time frame: maximum duration: 10 minutes
The presence of unilateral and bilateral DELC in the right and/or left ear was assessed across smoking status groups defined as current, non-smoker, and former. Categorical variables were presented as counts and percentages. Comparisons between groups were performed using the chi-square test. Differences with p-values < 0.05 were considered statistically significant.
3 secondary outcomes
Relationship between the participants' chronic diseases, medication use, family history, and the presence of DELC (diagonal earlobe crease)
Time frame: maximum duration: 10 minutes
Analysis of the relationship between DELC and the presence of cardiac/noncardiac diseases and medication use
Time frame: maximum duration: 10 minutes
Demographic characteristics of the participants
Time frame: maximum duration: 10 minutes
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 23 Feb 2026.
- Background: PubMed 30511968Linden OE, He JK, Morrison CS, Sullivan SR, Taylor HOB. The Relationship between Age and Facial Asymmetry. Plast Reconstr Surg. 2018 Nov;142(5):1145-1152. doi: 10.1097/PRS.0000000000004831.
- Background: PubMed 38512009Teul IB, Swiniarska B, Flis W, Wronka I. Fluctuating asymmetry of human morphometric features as a marker of developmental instability caused by adverse environmental conditions. Folia Morphol (Warsz). 2024;83(4):893-901. doi: 10.5603/fm.98782. Epub 2024 Mar 21.
- Background: PubMed 29114032Schou AL, Molbak ML, Schnor P, Gronbaek M, Tolstrup JS. Alcohol consumption, smoking and development of visible age-related signs: a prospective cohort study. J Epidemiol Community Health. 2017 Dec;71(12):1177-1184. doi: 10.1136/jech-2016-208568.
- Background: PubMed 27979353Charlier P, Deo S. Modern diagnosis of Flaubert's death mask. Lancet Neurol. 2017 Jan;16(1):31. doi: 10.1016/S1474-4422(16)30354-4. No abstract available.
- Background: PubMed 845360Doering C, Ruhsenberger C, Phillips DS. Ear lobe creases and heart disease. J Am Geriatr Soc. 1977 Apr;25(4):183-5. doi: 10.1111/j.1532-5415.1977.tb00290.x.
- Background: PubMed 24866080Lucenteforte E, Romoli M, Zagli G, Gensini GF, Mugelli A, Vannacci A. Ear lobe crease as a marker of coronary artery disease: a meta-analysis. Int J Cardiol. 2014 Jul 15;175(1):171-5. doi: 10.1016/j.ijcard.2014.04.025. Epub 2014 Apr 13. No abstract available.
- Background: PubMed 16738431Edston E. The earlobe crease, coronary artery disease, and sudden cardiac death: an autopsy study of 520 individuals. Am J Forensic Med Pathol. 2006 Jun;27(2):129-33. doi: 10.1097/01.paf.0000221067.73173.d7.
- Background: PubMed 24334176Christoffersen M, Frikke-Schmidt R, Schnohr P, Jensen GB, Nordestgaard BG, Tybjaerg-Hansen A. Visible age-related signs and risk of ischemic heart disease in the general population: a prospective cohort study. Circulation. 2014 Mar 4;129(9):990-8. doi: 10.1161/CIRCULATIONAHA.113.001696. Epub 2013 Dec 13.
- Background: PubMed 24708687Wu XL, Yang DY, Zhao YS, Chai WH, Jin ML. Diagonal earlobe crease and coronary artery disease in a Chinese population. BMC Cardiovasc Disord. 2014 Apr 4;14:43. doi: 10.1186/1471-2261-14-43.
- Background: PubMed 34915852Thilo C, Meisinger C, Heier M, von Scheidt W, Kirchberger I. Diagonal earlobe crease and long-term survival after myocardial infarction. BMC Cardiovasc Disord. 2021 Dec 16;21(1):597. doi: 10.1186/s12872-021-02425-4.
- Background: PubMed 35179701Prangenberg J, Doberentz E, Johann L, Madea B. The prognostic value of the Frank sign. Forensic Sci Med Pathol. 2022 Jun;18(2):149-155. doi: 10.1007/s12024-022-00463-8. Epub 2022 Feb 18.
- Background: PubMed 28438303Oda N, Maruhashi T, Kishimoto S, Kajikawa M, Iwamoto Y, Iwamoto A, Matsui S, Hidaka T, Kihara Y, Chayama K, Goto C, Aibara Y, Nakashima A, Noma K, Hirano H, Higashi Y. Relation of the Bilateral Earlobe Crease to Endothelial Dysfunction. Am J Cardiol. 2017 Jun 15;119(12):1983-1988. doi: 10.1016/j.amjcard.2017.03.029. Epub 2017 Mar 29.
- 3\. T.C. Sağlık Bakanlığı. Sağlık istatistikleri yıllığı 2023 \[Internet\]. Ankara: Sağlık Bilgi Sistemleri Genel Müdürlüğü; 2025 \[cited 2025 Apr 4\].Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. I am reluctant to share it because of some ethical considerations.
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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.
Onur Öztürk study director
Amasya University
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 Smoking ( Cigarette) and Cardiovascular Disease, run by Samsun University 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 23 Feb 2026. 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?
Analysis of the relationship between DELC (diagonal earlobe crease) and smoking consumption (time frame: maximum duration: 10 minutes). 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?
On the ClinicalTrials.gov record for NCT07427745, which also lists 33 linked publications.
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 23 Feb 2026.