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Earlobe Crease as Risk Factors of Acute Myocardial Infarction in Chinese Population

Earlobe Crease as Risk Factors of Acute Myocardial Infarction in Chinese Population

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02637661
Acronym
ELC-AMI-CHN
Enrollment
236
Registered
2015-12-22
Start date
2015-06-30
Completion date
2018-12-31
Last updated
2016-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ear/*Abnormalities, Risk Factor

Keywords

earlobe crease, acute myocardial infarction, risk factor

Brief summary

The purpose of this study is to explore the earlobe crease as a risk factor of acute myocardial infarction (AMI)in the Chinese population, combined with other risk factors, to predict high risk patients with coronary heart disease.

Detailed description

Primary objectives: Odds ratio and 95% confidence interval of binaural earlobe crease as risk factors of AMI. Secondary objectives: 1. To study the characteristics of different earlobe creases in different gender of the patients with AMI. 2. To analyze the characteristics of earlobe crease in different age groups. 3. To compare the feature of earlobe crease in acute ST elevation myocardial infarction and non ST elevation myocardial infarction. 4. The sensitivity,specificity,positive likelihood ratio and negative likelihood ratio of binaural earlobe crease as risk factors of AMI.

Interventions

OTHERearlobe crease positive
OTHERearlobe crease negative

Sponsors

General Hospital of Shenyang Military Region
CollaboratorOTHER
Beihua University
CollaboratorOTHER
Zhejiang Provincial Tongde Hospital
CollaboratorOTHER
Zhejiang Chinese Medical University
CollaboratorOTHER_GOV
Jing Qi
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

1. Initial acute myocardial infarction(AMI). 2. Detection of a rise and/or fall of cardiac biomarker values (preferably cardiac troponin(cTn) with at least one value above the 99th percentile upper reference limit(URL)) and with at least one of the following: * Symptoms of ischemia * Development of pathologic Q waves in the electrocardiogram (ECG) * New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB). * Identification of an intracoronary thrombus by angiography or autopsy * Imaging evidence of new loss of viable myocardium or a new regional wall motion abnormality. 3. Type 1 (spontaneous myocardial infarction(MI)) in the third universal definition of MI: MI consequent to a pathologic process in the wall of the coronary artery (eg, plaque erosion/rupture, fissuring, or dissection), resulting in intraluminal thrombus. 4. Infarct related artery (IRA) showed that acute thrombus formation, IRA occlusion or stenosis ≥95%、≥90%~95%、≤90%,thrombolysis in myocardial infarction(TIMI) 0-3 flow. 5. Signed informed consent.

Exclusion criteria

1. Combined valvular heart disease, cardiomyopathy, blood diseases, skin diseases, rheumatic diseases, ischemic cerebrovascular disease, tumor, etc. 2. Previous myocardial infarction. 3. Previous percutaneous coronary intervention(PCI) and coronary artery bypass graft(CABG). 4. Chronic total occlusion(CTO)lesions. 5. Ear malformation. 6. Ocular diseases. 7. Participating in a clinical study.

Design outcomes

Primary

MeasureTime frame
Odds ratio(OR,the ratio of the explosure number and non-explosure in case group/ the ratio of the explosure number and non-explosure in control group) and 95% confidence interval were calculated of binaural earlobe crease≥ 7 scores as risk factors of AMI3 years

Secondary

MeasureTime frame
To compare the score of the ELC in acute ST elevation myocardial infarction and non ST elevation myocardial infarction.3 years
The score of the ELC in different gender of the patients with AMI.3 years
The score of ELC in different age groups.3 years
The sensitivity(true positive/true positive+false negative) and specificity(true negative/true negative+false positive) of binaural earlobe crease≥ 7 scores as risk factors of AMI.3 years
Positive likelihood ratio(+LR,sensitivity/1-speccificity)and negative likelihood ratio(-LR,1-sensitivity/specificity)of binaural earlobe crease≥ 7 scores as risk factors of AMI3 years

Countries

China

Contacts

Primary ContactJing Qi, Master
saraok@126.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026