- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07427745
SMOKING AND PRESENCE OF FRANK'S SIGN
PRESENCE OF FRANK'S SIGN: A COMPARATIVE EVALUATION IN SMOKERS AND NON-SMOKERS
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Samsun, Turkey (Türkiye)
- Samsun University Training and Research Hospital (Samsun City Hospital)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Individuals aged 40-59 years who presented to the relevant outpatient clinics were included in the study.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
smokers
Smoking individuals aged between 40 and 59 years.
|
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
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)
|
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non-smokers (control group)
Individuals aged between 40 and 59 years who do not smoke
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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
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
|
maximum duration: 10 minutes
|
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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.
|
maximum duration: 10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relationship between the participants' chronic diseases, medication use, family history, and the presence of DELC (diagonal earlobe crease)
Time Frame: maximum duration: 10 minutes
|
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.
|
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
|
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. |
maximum duration: 10 minutes
|
|
Demographic characteristics of the participants
Time Frame: maximum duration: 10 minutes
|
Demographic characteristics like sex, marital status and smoking status of the participants were evaluated
|
maximum duration: 10 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Onur Öztürk, Amasya University
Publications and helpful links
General 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):1145-52.
- Teul IB, Świniarska B, Flis W, Wronka I. Fluctuating asymmetry of human morphometric features as a marker of developmental instability caused by adverse environmental conditions. Folia Morphol. 2024 Mar 15;VM/OJS/J/98782.
- Schou AL, Mølbak ML, Schnor P, Grønbæk 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):1177-84.
- Charlier P, Deo S. Modern diagnosis of Flaubert's death mask. Lancet Neurol. 2017;16(1):31.
- Doering C, Ruhsenberger C, Phillips DS. Ear-lobe creases and heart disease. J Am Geriatr Soc. 1977 Apr;25(4):183-5.
- Lucenteforte 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;175(1):171-5.
- Edston 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.
- Christoffersen M, Frikke-Schmidt R, Schnohr P, Jensen GB, Nordestgaard BG, Tybjærg-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.
- Wu 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.
- Thilo 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;21(1):597.
- Prangenberg J, Doberentz E, Johann L, Madea B. The prognostic value of the Frank sign. Forensic Sci Med Pathol. 2022 Jun;18(2):149-55.
- Oda N, Maruhashi T, Kishimoto S, Kajikawa M, Iwamoto Y, Iwamoto A, et al. Relation of the bilateral earlobe crease to endothelial dysfunction. Am J Cardiol. 2017 Jun;119(12):1983-8.
- Xu J, Wang L, Zhang C, Wang J, Zheng D, Huang Y, et al. The prognostic value of deep earlobe creases in patients with acute ischemic stroke. Front Cardiovasc Med
- Rodríguez-López C, Garlito-Díaz H, Madroñero-Mariscal R, Sánchez-Cervilla PJ, Graciani A, López-Sendón JL, et al. Earlobe crease shapes and cardiovascular events. Am J Cardiol. 2015 Jul 15;116(2):286-93.
- Pasternac 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.
- Sprague DH. Diagonal ear-lobe crease as an indicator of operative risk. Anesthesiology. 1976 Sep 1;45(3):362-3.
- Verma SK, Khamesra R, Mehta LK, Bordia A. Ear-lobe crease and ear-canal hair as predictors of coronary artery disease in Indian population. Indian Heart J. 1989;41(2):86-91.
- Zarghami F, Rajabi A, Abed-Tazehabadi R, Charkazi A, Shahryari A. Cigarette smoking and perceived risk of cardiovascular disease in Iran. BMC Public Health. 2025 Jan 17;25(1):198.
- Abrahim M. Unified anatomical explanation of diagonal earlobe creases, preauricular creases, and paired creases of the helix. Cureus [Internet]. 2022 Aug 12 [cited 2025 Apr 19].
- Curtis J, Walford S. Why we should be looking for ear lobe creases: a systematic review and meta-analysis of diagonal ear lobe crease and coronary artery disease.
- Agouridis AP, Elisaf MS, Nair DR, Mikhailidis DP. Ear lobe crease: a marker of coronary artery disease? Arch Med Sci. 2015;6:1145-55.
- Bahcelioglu M, Isik AF, Demirel B, Senol E, Aycan S. The diagonal ear-lobe crease as sign of some diseases. Saudi Med J. 2005 Jun;26(6):947-51.
- Aksu F, Akkoc RF. Prevalence of Frank's sign in healthy young individuals, morphological characteristics, and its association with family history of chronic disease. Forensic Sci Med Pathol. 2024 Aug 2;20(4):1187-92.
- Nazzal S, Blum A. Association between the Frank sign and cardiovascular events. South Med J. 2018 Aug 1;111:504-9.
- Stoyanov GS, Dzhenkov D, Petkova L, Velkova D, Sapundzhiev N, Ghenev P. Frank's sign and paired ear creases of the helix. Wien Klin Wochenschr. 2022 Mar 1;134(5):237-42.
- Pathmarajah P, Rowland Payne C. Paired ear creases of the helix (PECH): a possible physical sign. Cureus. 2017 Nov 27;9(11):e1884.
- Patel V, Champ C, Andrews PS, Gostelow BE, Gunasekara NPR, Davidson AR. Diagonal earlobe creases and atheromatous disease: a postmortem study. J R Coll Physicians Lond. 1992 Jul;26(3):274-7.
- Temeecharoentaworn K, Tiamkao S, Ienghong K, Cheung LW, Apiratwarakul K. Relationship between diagonal earlobes crease and ischemic stroke risk. Open Access Maced J Med Sci. 2022 Feb 23;10(E):269-73.
- Frank ST. Aural sign of coronary artery disease. N Engl J Med. 1973;289:327-8.
- Akman M, Civek S. Dünyada ve Türkiye'de kardiyovasküler hastalıkların sıklığı ve riskin değerlendirilmesi. J Turk Fam Physician. 2022 Mar 30;13(1):21-8.
- Akı M, Karaca M, Türk H. Sigaraya bağlı artan kardiyovasküler hastalık riskini düşürme. Türkiye Sağlık Okuryazarlığı Derg. 2021 Jul 1;2(2):111-8.
- Ozturk O, Ozturk G, Yazıcıoglu B, Yalcın B, Unal M. Smoking frequency, cessation knowledge; attitudes and beliefs among internal and surgery residents. J Exp Clin Med. 2016;32(4):171-5.
- Öztürk O, Yavuz E, Özdemir M, Ayraler A. Bir aile sağlığı merkezi bünyesinde kurulan sigara bıraktırma kliniğine müracaat eden hastaların analizi. Bağımlılık Derg. 2023;24(4):507-13.
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/11/1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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