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Clinical Trials/NCT02637661
NCT02637661UnknownNot Applicable

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

Jing Qi1 site in 1 country236 target enrollmentStarted: June 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
236
Locations
1
Primary Endpoint
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
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Initial acute myocardial infarction(AMI).
  • •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.
  • •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.
  • •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.
  • •Signed informed consent.

Exclusion Criteria

  • •Combined valvular heart disease, cardiomyopathy, blood diseases, skin diseases, rheumatic diseases, ischemic cerebrovascular disease, tumor, etc.
  • •Previous myocardial infarction.
  • •Previous percutaneous coronary intervention(PCI) and coronary artery bypass graft(CABG).
  • •Chronic total occlusion(CTO)lesions.
  • •Ear malformation.
  • •Ocular diseases.
  • •Participating in a clinical study.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • To compare the score of the ELC in acute ST elevation myocardial infarction and non ST elevation myocardial infarction.(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.(3 years)
  • The score of ELC in different age groups.(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(3 years)
  • The score of the ELC in different gender of the patients with AMI.(3 years)

Investigators

Sponsor
Jing Qi
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Jing Qi

Principal investigator

Liaoning University of Traditional Chinese Medicine

Study Sites (1)

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