Clinical trial NCT02637661: Earlobe Crease as Risk Factors of Acute Myocardial Infarction in Chinese Population
Official title: Earlobe Crease as Risk Factors of Acute Myocardial Infarction in Chinese Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ear/*Abnormalities
Risk Factor
Keywords: earlobe crease
acute myocardial infarction
risk factor
Lead sponsor: Liaoning University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: General Hospital of Shenyang Military Region
name: Beihua University
name: Zhejiang Provincial Tongde Hospital
name: Zhejiang Chinese Medical University
First posted: 2015-12-22
Enrollment: 236
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The case group is Initial acute myocardial infarction(AMI),the control group is no coronary heart disease

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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 AMI
timeFrame: 3 years
Secondary outcomes:
measure: The score of the ELC in different gender of the patients with AMI.
timeFrame: 3 years
measure: The score of ELC in different age groups.
timeFrame: 3 years
measure: To compare the score of the ELC in acute ST elevation myocardial infarction and non ST elevation myocardial infarction.
timeFrame: 3 years
measure: 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.
timeFrame: 3 years
measure: 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 AMI
timeFrame: 3 years
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Jing
state: Liaoning
Study officials:
affiliation: Liaoning University of Traditional Chinese Medecine
name: Junwen Jiang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: