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

NCT ID: NCT02637661

Last Updated: 2016-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

236 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Ear/*Abnormalities Risk Factor

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Initial AMI

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

earlobe crease positive

Intervention Type OTHER

earlobe crease negative

Intervention Type OTHER

No coronary heart disease

To study the characteristics of earlobe crease

earlobe crease positive

Intervention Type OTHER

earlobe crease negative

Intervention Type OTHER

Interventions

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earlobe crease positive

Intervention Type OTHER

earlobe crease negative

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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General Hospital of Shenyang Military Region

OTHER

Sponsor Role collaborator

Beihua University

OTHER

Sponsor Role collaborator

Zhejiang Provincial Tongde Hospital

OTHER

Sponsor Role collaborator

Zhejiang Chinese Medical University

OTHER_GOV

Sponsor Role collaborator

Jing Qi

OTHER

Sponsor Role lead

Responsible Party

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Jing Qi

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Junwen Jiang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Liaoning University of Traditional Chinese Medecine

Locations

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Jing

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jing Qi, Master

Role: CONTACT

Facility Contacts

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Jing Qi, master

Role: primary

Other Identifiers

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JQi1

Identifier Type: -

Identifier Source: org_study_id

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