Clinical trial NCT02618681: Earlobe Creases Predict Prognosis in Chinese Patients With Acute Myocardial Infarction
Official title: Earlobe Creases Predict Prognosis in Chinese Patients With Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ear Abnormalities
Prognosis
Keywords: earlobe crease
acute myocardial infarction
Lead sponsor: Liaoning University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 902
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: acute myocardial infarction

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

Eligibility criteria: 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. PCI(percutaneous coronary intervention)intervention（PCI for STEMI within 12 hours after symptom onset）.
6. 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 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.

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Jing
state: Liaoning
Study officials:
affiliation: Liaoning University of Traditional Chinese Medecine
name: Junwen Jiang, Doctor
role: STUDY_DIRECTOR
References: