Earlobe Creases Predict Prognosis in Chinese Patients With Acute Myocardial Infarction
ELC-CHN
1 other identifier
observational
902
1 country
1
Brief Summary
To investigate the feasibility of the earlobe crease as an early prognostic predictor for acute myocardial infarction(AMI) in Chinese population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 27, 2015
CompletedFirst Posted
Study publicly available on registry
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedDecember 8, 2015
December 1, 2015
4 years
November 27, 2015
December 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 year
Study Arms (2)
AMI with earlobe crease
To observe the prognosis for AMI with earlobe crease
AMI without earlobe crease
To observe the prognosis for AMI without earlobe crease
Eligibility Criteria
acute myocardial infarction
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.
- PCI(percutaneous coronary intervention)intervention（PCI for STEMI within 12 hours after symptom onset）.
- 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 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
- Jing Qilead
Study Sites (1)
Jing
Shenyang, Liaoning, 024, China
Study Officials
- STUDY DIRECTOR
Junwen Jiang, Doctor
Liaoning University of Traditional Chinese Medecine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
November 27, 2015
First Posted
December 1, 2015
Study Start
June 1, 2015
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
December 8, 2015
Record last verified: 2015-12