NCT02637661

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
236

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 11, 2016

Status Verified

January 1, 2016

Enrollment Period

3.5 years

First QC Date

November 30, 2015

Last Update Submit

January 8, 2016

Conditions

Ear/*AbnormalitiesRisk Factor

Keywords

earlobe creaseacute myocardial infarctionrisk factor

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • The score of the ELC in different gender of the patients with AMI.

    3 years

  • The score of ELC in different age groups.

    3 years

  • 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

  • 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

Study Arms (2)

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 positiveOther: earlobe crease negative

No coronary heart disease

To study the characteristics of earlobe crease

Other: earlobe crease positiveOther: earlobe crease negative

Interventions

earlobe crease positiveOTHER
Initial AMINo coronary heart disease
earlobe crease negativeOTHER
Initial AMINo coronary heart disease

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jing

Shenyang, Liaoning, 024, China

RECRUITING

Study Officials

  • Junwen Jiang, Doctor

    Liaoning University of Traditional Chinese Medecine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Qi, Master

CONTACT

saraok@126.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 30, 2015

First Posted

December 22, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 11, 2016

Record last verified: 2016-01

Locations

CN(1)