Earlobe Crease as Risk Factors of Acute Myocardial Infarction in Chinese Population (ELC-AMI-CHN)

Jing Qi

Status: Unknown

Conditions: Ear/*Abnormalities; Risk Factor

Treatments: Other: earlobe crease negative; Other: earlobe crease positive

Study type: Observational

Funder types: Other

Identifiers

NCT02637661

JQi1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 236 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

236 participants in 2 patient groups

Initial AMI

Description:

To study the sensitivity, specificity, positive predictive value, and negative predictive value of different earlobe crease as risk factors of AMI

Treatment:

Other: earlobe crease positive

Other: earlobe crease negative

No coronary heart disease

Description:

To study the characteristics of earlobe crease

Treatment:

Other: earlobe crease positive

Other: earlobe crease negative