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Earlobe Creases Predict Prognosis in Chinese Patients With Acute Myocardial Infarction

NCT ID: NCT02618681

Last Updated: 2015-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

902 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2019-06-30

Brief Summary

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

Detailed Description

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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

Conditions

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Ear Abnormalities Prognosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AMI with earlobe crease

To observe the prognosis for AMI with earlobe crease

Intervention Type OTHER

AMI without earlobe crease

To observe the prognosis for AMI without earlobe crease

Intervention Type OTHER

Interventions

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Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jing Qi

OTHER

Sponsor Role lead

Responsible Party

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Jing Qi

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Junwen Jiang, Doctor

Role: STUDY_DIRECTOR

Liaoning University of Traditional Chinese Medecine

Locations

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Jing

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jing Qi, Master

Role: CONTACT

[email protected]

Facility Contacts

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Jing Qi, master

Role: primary

[email protected]

Other Identifiers

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JQi

Identifier Type: -

Identifier Source: org_study_id