Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2025-12-27 @ 9:30 PM
Study NCT ID:
NCT02637661
Status:
UNKNOWN
Last Update Posted:
2016-01-11
First Post:
2015-11-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Earlobe Crease as Risk Factors of Acute Myocardial Infarction in Chinese Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 236}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-08', 'studyFirstSubmitDate': '2015-11-30', 'studyFirstSubmitQcDate': '2015-12-18', 'lastUpdatePostDateStruct': {'date': '2016-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'The score of the ELC in different gender of the patients with AMI.', 'timeFrame': '3 years'}, {'measure': 'The score of ELC in different age groups.', 'timeFrame': '3 years'}, {'measure': 'To compare the score of the ELC in acute ST elevation myocardial infarction and non ST elevation myocardial infarction.', 'timeFrame': '3 years'}, {'measure': '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.', 'timeFrame': '3 years'}, {'measure': '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', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['earlobe crease', 'acute myocardial infarction', 'risk factor'], 'conditions': ['Ear/*Abnormalities', 'Risk Factor']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Primary objectives: Odds ratio and 95% confidence interval of binaural earlobe crease as risk factors of AMI.\n\nSecondary objectives:\n\n1. To study the characteristics of different earlobe creases in different gender of the patients with AMI.\n2. To analyze the characteristics of earlobe crease in different age groups.\n3. To compare the feature of earlobe crease in acute ST elevation myocardial infarction and non ST elevation myocardial infarction.\n4. The sensitivity,specificity,positive likelihood ratio and negative likelihood ratio of binaural earlobe crease as risk factors of AMI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The case group is Initial acute myocardial infarction(AMI),the control group is no coronary heart disease', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Initial acute myocardial infarction(AMI).\n2. 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:\n\n * Symptoms of ischemia\n * Development of pathologic Q waves in the electrocardiogram (ECG)\n * New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB).\n * Identification of an intracoronary thrombus by angiography or autopsy\n * Imaging evidence of new loss of viable myocardium or a new regional wall motion abnormality.\n3. 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.\n4. 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.\n5. Signed informed consent.\n\nExclusion Criteria:\n\n1. Combined valvular heart disease, cardiomyopathy, blood diseases, skin diseases, rheumatic diseases, ischemic cerebrovascular disease, tumor, etc.\n2. Previous myocardial infarction.\n3. Previous percutaneous coronary intervention(PCI) and coronary artery bypass graft(CABG).\n4. Chronic total occlusion(CTO)lesions.\n5. Ear malformation.\n6. Ocular diseases.\n7. Participating in a clinical study.'}, 'identificationModule': {'nctId': 'NCT02637661', 'acronym': 'ELC-AMI-CHN', 'briefTitle': 'Earlobe Crease as Risk Factors of Acute Myocardial Infarction in Chinese Population', 'organization': {'class': 'OTHER', 'fullName': 'Liaoning University of Traditional Chinese Medicine'}, 'officialTitle': 'Earlobe Crease as Risk Factors of Acute Myocardial Infarction in Chinese Population', 'orgStudyIdInfo': {'id': 'JQi1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Initial AMI', 'description': 'To study the sensitivity, specificity, positive predictive value, and negative predictive value of different earlobe crease as risk factors of AMI', 'interventionNames': ['Other: earlobe crease positive', 'Other: earlobe crease negative']}, {'label': 'No coronary heart disease', 'description': 'To study the characteristics of earlobe crease', 'interventionNames': ['Other: earlobe crease positive', 'Other: earlobe crease negative']}], 'interventions': [{'name': 'earlobe crease positive', 'type': 'OTHER', 'armGroupLabels': ['Initial AMI', 'No coronary heart disease']}, {'name': 'earlobe crease negative', 'type': 'OTHER', 'armGroupLabels': ['Initial AMI', 'No coronary heart disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '024', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing Qi, master', 'role': 'CONTACT', 'email': 'saraok@126.com'}, {'name': 'Junwen Jiang, doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yi Li, doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Heyang Wang, doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jing Li, master', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dan Bao, master', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xufeng Chen, master', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Donghao Chen, master', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lili Meng, master', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jiadan Liao, master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jing', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Jing Qi, Master', 'role': 'CONTACT', 'email': 'saraok@126.com'}], 'overallOfficials': [{'name': 'Junwen Jiang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Liaoning University of Traditional Chinese Medecine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jing Qi', 'class': 'OTHER'}, 'collaborators': [{'name': 'General Hospital of Shenyang Military Region', 'class': 'OTHER'}, {'name': 'Beihua University', 'class': 'OTHER'}, {'name': 'Zhejiang Provincial Tongde Hospital', 'class': 'OTHER'}, {'name': 'Zhejiang Chinese Medical University', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Jing Qi', 'investigatorAffiliation': 'Liaoning University of Traditional Chinese Medicine'}}}}