Earlobe Creases Predict Prognosis in Chinese Patients Wit... | NCT02618681

Studies
Earlobe Creases Predict Prognosis in Chinese Patients With Acute Myocardial Infarction

NCT02618681

Sponsor

Jing Qi

Status

Unknown status

Last Update Posted

Dec 8, 2015Estimated

Enrollment

902Estimated

Phase

Not provided

Conditions

Ear Abnormalities
Prognosis

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Jun 2019Estimated

Completion Date

Jun 2019Estimated

First Submitted Date

Nov 27, 2015

First Submission Date that Met QC Criteria

Nov 30, 2015

First Posted Date

Dec 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2015

Last Update Posted Date

Dec 8, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

902Estimated

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
	Other		AMI with earlobe crease AMI without earlobe crease

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

acute myocardial infarction

Sampling Method

Probability Sample