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

Risk Factor Clinical Trial

— ELC-AMI-CHN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02637661
• Other study ID #: JQi1
• Status: Recruiting
• Phase: N/A
• First received: November 30, 2015
• Last updated: January 8, 2016
• Start date: June 2015
• Est. completion date: December 2018

Study information

• Verified date: January 2016
• Source: Liaoning University of Traditional Chinese Medicine
• Contact: Jing Qi, Master
• Email: saraok[@]126.com
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 236
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Ear/*Abnormalities
• Infarction
• Myocardial Infarction
• Risk Factor

Intervention

Other:
• earlobe crease positive

• earlobe crease negative

Locations

Country	Name	City	State
China	Jing	Shenyang	Liaoning

Sponsors (5)

Lead Sponsor	Collaborator
Jing Qi	Beihua University, General Hospital of Shenyang Military Region, Zhejiang Chinese Medical University, Zhejiang Provincial Tongde Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		3 years	No
Secondary	The score of the ELC in different gender of the patients with AMI.		3 years	No
Secondary	The score of ELC in different age groups.		3 years	No
Secondary	To compare the score of the ELC in acute ST elevation myocardial infarction and non ST elevation myocardial infarction.		3 years	No
Secondary	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	No
Secondary	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		3 years	No