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Clinical Trials/NCT02618681
NCT02618681UnknownNot Applicable

Earlobe Creases Predict Prognosis in Chinese Patients With Acute Myocardial Infarction

Jing Qi1 site in 1 country902 target enrollmentStarted: June 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
902
Locations
1
Primary Endpoint
primary composite end point (including the whole death, recurrent myocardial infarction, stroke, target vessel revascularization, stent thrombosis) in AMI patients with different types of earlobe crease.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To investigate the feasibility of the earlobe crease as an early prognostic predictor for acute myocardial infarction(AMI) in Chinese population.

Detailed Description

Primary Objective : 1 year primary composite end point (including the whole death, recurrent myocardial infarction, stroke, target vessel revascularization, stent thrombosis) in AMI patients with different types of earlobe crease.

Secondary objective:

  1. The incidence of complications during hospitalization
  2. The rate of rehospitalization due to cardiovascular disease
  3. The incidence of revascularization at 1 year after AMI

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.
  • •PCI(percutaneous coronary intervention)intervention（PCI for STEMI within 12 hours after symptom onset）.
  • •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 PCI and coronary artery bypass graft(CABG).
  • •Chronic total occlusion(CTO)lesions.
  • •Ear malformation.
  • •Ocular diseases.
  • •Participating in a clinical study.

Outcomes

Primary Outcomes

primary composite end point (including the whole death, recurrent myocardial infarction, stroke, target vessel revascularization, stent thrombosis) in AMI patients with different types of earlobe crease.

Time Frame: 1 year

Secondary Outcomes

No secondary outcomes reported

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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