Ear/*AbnormalitiesELC-AMI-CHNNCT02637661
Earlobe Crease as Risk Factors of Acute Myocardial Infarction in Chinese Population
An observational study of Ear/*Abnormalities and Risk Factor, run by Jing Qi at 1 site in China.
Trial summary
The purpose of this study is to explore the earlobe crease as a risk factor of acute myocardial infarction (AMI)in the Chinese population, combined with other risk factors, to predict high risk patients with coronary heart disease. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ear/*Abnormalities, Risk Factor
- What is being tested?
- earlobe crease positive and earlobe crease negative
- How many people
- 236 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Dec 2018
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The case group is Initial acute myocardial infarction(AMI),the control group is no coronary heart disease
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
Show all 10Show fewer
- 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.
- 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 percutaneous coronary intervention(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
The purpose of this study is to explore the earlobe crease as a risk factor of acute myocardial infarction (AMI)in the Chinese population, combined with other risk factors, to predict high risk patients with coronary heart disease.
Read the detailed description
Primary objectives: Odds ratio and 95% confidence interval of binaural earlobe crease as risk factors of AMI.
Secondary objectives:
- To study the characteristics of different earlobe creases in different gender of the patients with AMI.
- To analyze the characteristics of earlobe crease in different age groups.
- To compare the feature of earlobe crease in acute ST elevation myocardial infarction and non ST elevation myocardial infarction.
- The sensitivity,specificity,positive likelihood ratio and negative likelihood ratio of binaural earlobe crease as risk factors of AMI.
- Conditions
- Ear/*Abnormalities, Risk Factor
- Being tested
- earlobe crease positive, earlobe crease negative
- Keywords
- earlobe crease, acute myocardial infarction, risk factor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
earlobe crease positiveOther
earlobe crease negativeOther
| Study group | Role | What they receive |
|---|---|---|
| Initial AMI | To study the sensitivity, specificity, positive predictive value, and negative predictive value of different earlobe crease as risk factors of AMI Receives: Other: earlobe crease positive; Other: earlobe crease negative | |
| No coronary heart disease | To study the characteristics of earlobe crease Receives: Other: earlobe crease positive; Other: earlobe crease negative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Odds ratio(OR，the ratio of the explosure number and non-explosure in case group/ the ratio of the explosure number and non-explosure in control group) and 95% confidence interval were calculated of binaural earlobe crease≥ 7 scores as risk factors of AMI
Measured: 3 years
Secondary outcomes (5)
The score of the ELC in different gender of the patients with AMI.
Measured: 3 years
The score of ELC in different age groups.
Measured: 3 years
To compare the score of the ELC in acute ST elevation myocardial infarction and non ST elevation myocardial infarction.
Measured: 3 years
The sensitivity(true positive/true positive+false negative) and specificity(true negative/true negative+false positive) of binaural earlobe crease≥ 7 scores as risk factors of AMI.
Measured: 3 years
Positive likelihood ratio(+LR，sensitivity/1-speccificity)and negative likelihood ratio(-LR，1-sensitivity/specificity)of binaural earlobe crease≥ 7 scores as risk factors of AMI
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jing Qi
- Sponsor type
- University, hospital or other
- Collaborators
- General Hospital of Shenyang Military Region, Beihua University, Zhejiang Provincial Tongde Hospital, Zhejiang Chinese Medical University
- Responsible party
- Sponsor-investigator, Jing Qi, Liaoning University of Traditional Chinese Medicine
- Investigators
- Junwen Jiang, Doctor, Principal investigator, Liaoning University of Traditional Chinese Medecine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637661
- Sponsor's protocol ID
- JQi1
- Acronym
- ELC-AMI-CHN
- Status last verified
- Jan 2016
- First submitted
- 30 Nov 2015
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Earlobe Crease as Risk Factors of Acute Myocardial Infarction in Chinese Population
- ClinicalTrials.gov ID
- NCT02637661
- Acronym / sponsor ID
- ELC-AMI-CHN / JQi1
- Conditions
- Ear/*Abnormalities, Risk Factor
- Keywords
- earlobe crease, acute myocardial infarction, risk factor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Jing QiUniversity, hospital or other
- Collaborators
- General Hospital of Shenyang Military Region, Beihua University, Zhejiang Provincial Tongde Hospital, Zhejiang Chinese Medical University
- Study start
- Jun 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 22 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.
The purpose of this study is to explore the earlobe crease as a risk factor of acute myocardial infarction (AMI)in the Chinese population, combined with other risk factors, to predict high risk patients with coronary heart disease.
Detailed description
Primary objectives: Odds ratio and 95% confidence interval of binaural earlobe crease as risk factors of AMI.
Secondary objectives:
- To study the characteristics of different earlobe creases in different gender of the patients with AMI.
- To analyze the characteristics of earlobe crease in different age groups.
- To compare the feature of earlobe crease in acute ST elevation myocardial infarction and non ST elevation myocardial infarction.
- The sensitivity,specificity,positive likelihood ratio and negative likelihood ratio of binaural earlobe crease as risk factors of AMI.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial AMI | – | Other: earlobe crease positive, Other: earlobe crease negativeTo study the sensitivity, specificity, positive predictive value, and negative predictive value of different earlobe crease as risk factors of AMI |
| No coronary heart disease | – | Other: earlobe crease positive, Other: earlobe crease negativeTo study the characteristics of earlobe crease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The case group is Initial acute myocardial infarction(AMI),the control group is no coronary heart disease
Key inclusion criteria (10 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.
- Signed informed consent.
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 percutaneous coronary intervention(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 |
|---|---|---|
| earlobe crease positive | Other | Initial AMI, No coronary heart disease |
| earlobe crease negative | Other | Initial AMI, No coronary heart disease |
Primary outcome
Odds ratio(OR，the ratio of the explosure number and non-explosure in case group/ the ratio of the explosure number and non-explosure in control group) and 95% confidence interval were calculated of binaural earlobe crease≥ 7 scores as risk factors of AMI
Time frame: 3 years
5 secondary outcomes
The score of the ELC in different gender of the patients with AMI.
Time frame: 3 years
The score of ELC in different age groups.
Time frame: 3 years
To compare the score of the ELC in acute ST elevation myocardial infarction and non ST elevation myocardial infarction.
Time frame: 3 years
The sensitivity(true positive/true positive+false negative) and specificity(true negative/true negative+false positive) of binaural earlobe crease≥ 7 scores as risk factors of AMI.
Time frame: 3 years
Positive likelihood ratio(+LR，sensitivity/1-speccificity)and negative likelihood ratio(-LR，1-sensitivity/specificity)of binaural earlobe crease≥ 7 scores as risk factors of AMI
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
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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 principal investigator
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 Risk Factor, 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 10 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 11 Jan 2016. 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?
Odds ratio(OR，the ratio of the explosure number and non-explosure in case group/ the ratio of the explosure number and non-explosure in control group) and 95% confidence interval were calculated of binaural earlobe crease≥ 7 scores as risk factors of AMI (time frame: 3 years). 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 11 Jan 2016.