Ear AbnormalitiesELC-CHNNCT02618681
Earlobe Creases Predict Prognosis in Chinese Patients With Acute Myocardial Infarction
An observational study of Ear Abnormalities and Prognosis, run by Jing Qi at 1 site in China.
Trial summary
To investigate the feasibility of the earlobe crease as an early prognostic predictor for acute myocardial infarction(AMI) in Chinese population. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ear Abnormalities, Prognosis
- How many people
- 902 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: acute myocardial infarction
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Jing Qi, Master contact
China1 site, 1 recruiting
- Recruiting
Jing
Shenyang, Liaoning, 024
Jing Qi, master, saraok@126.com
Junwen Jiang, doctor
About this study
To investigate the feasibility of the earlobe crease as an early prognostic predictor for acute myocardial infarction(AMI) in Chinese population.
Read the 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
- Conditions
- Ear Abnormalities, Prognosis
- Keywords
- earlobe crease, acute myocardial infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ear AbnormalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 902 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jing Qi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jing Qi, Liaoning University of Traditional Chinese Medicine
- Investigators
- Junwen Jiang, Doctor, Study director, Liaoning University of Traditional Chinese Medecine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618681
- Sponsor's protocol ID
- JQi
- Acronym
- ELC-CHN
- Status last verified
- Dec 2015
- First submitted
- 27 Nov 2015
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Earlobe Creases Predict Prognosis in Chinese Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02618681
- Acronym / sponsor ID
- ELC-CHN / JQi
- Conditions
- Ear Abnormalities, Prognosis
- Keywords
- earlobe crease, acute myocardial infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 902 participants (estimated)
- Lead sponsor
- Jing QiUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- acute myocardial infarction
Key inclusion criteria (11 listed)
- 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:
- 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）.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other | AMI with earlobe crease, AMI without earlobe crease |
Primary outcome
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.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Qi, Master contact
Junwen Jiang, Doctor study director
Liaoning University of Traditional Chinese Medecine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ear Abnormalities and Prognosis, run by Jing Qi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Qi, Master (saraok@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2015.