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

January 8, 2016 updated by: Jing Qi
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

236

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 024
        • Recruiting
        • Jing
        • Contact:
        • Principal Investigator:
          • Junwen Jiang, doctor
        • Principal Investigator:
          • Yi Li, doctor
        • Principal Investigator:
          • Heyang Wang, doctor
        • Principal Investigator:
          • Jing Li, master
        • Principal Investigator:
          • Dan Bao, master
        • Principal Investigator:
          • Xufeng Chen, master
        • Principal Investigator:
          • Donghao Chen, master
        • Principal Investigator:
          • Lili Meng, master
        • Principal Investigator:
          • Jiadan Liao, master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The case group is Initial acute myocardial infarction(AMI),the control group is no coronary heart disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Initial AMI
To study the sensitivity, specificity, positive predictive value, and negative predictive value of different earlobe crease as risk factors of AMI
Other: earlobe crease positive
Other: earlobe crease negative
No coronary heart disease
To study the characteristics of earlobe crease
Other: earlobe crease positive
Other: earlobe crease negative

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time 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 AMI
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
The score of the ELC in different gender of the patients with AMI.
Time Frame: 3 years
3 years
The score of ELC in different age groups.
Time Frame: 3 years
3 years
To compare the score of the ELC in acute ST elevation myocardial infarction and non ST elevation myocardial infarction.
Time Frame: 3 years
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.
Time Frame: 3 years
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 AMI
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jing Qi

Collaborators

General Hospital of Shenyang Military Region
Zhejiang Chinese Medical University
Zhejiang Provincial Tongde Hospital
Beihua University

Investigators

  • Principal Investigator: Junwen Jiang, Doctor, Liaoning University of Traditional Chinese Medecine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

November 30, 2015

First Submitted That Met QC Criteria

December 18, 2015

First Posted (Estimate)

December 22, 2015

Study Record Updates

Last Update Posted (Estimate)

January 11, 2016

Last Update Submitted That Met QC Criteria

January 8, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JQi1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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