Earlobe Creases Predict Prognosis in Chinese Patients With Acute Myocardial Infarction (ELC-CHN)

Jing Qi

Status: Unknown

Conditions: Ear Abnormalities; Prognosis

Study type: Observational

Funder types: Other

Identifiers

NCT02618681

JQi

Details and patient eligibility

About

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

Full 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

Enrollment: 902 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

902 participants in 2 patient groups

AMI with earlobe crease

Description:

To observe the prognosis for AMI with earlobe crease

AMI without earlobe crease

Description:

To observe the prognosis for AMI without earlobe crease