Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-03-01 @ 8:59 PM
Study NCT ID:
NCT01750502
Status:
COMPLETED
Last Update Posted:
2015-03-04
First Post:
2012-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Clinical Diagnosis Meaning of MIF in Coronary Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jiftang@126.com', 'phone': '15968766021', 'title': 'Dr. JiFei Tang', 'organization': 'Department of Cardiology, the Second Affiliated Hospital, Wenzhou Medical University, Zhejiang province, Wenzhou,China'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'There are some limitations to this research. First, the sample size was relative small. Second,no participants were retrospectively analyzed.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Coronary-artery-disease Group', 'description': 'Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.', 'otherNumAtRisk': 70, 'otherNumAffected': 0, 'seriousNumAtRisk': 70, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-coronary-artery-disease Group', 'description': 'Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.', 'otherNumAtRisk': 186, 'otherNumAffected': 0, 'seriousNumAtRisk': 186, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comparison Between Coronary-artery-disease Group and Non-coronary-artery-disease Group on MIF Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-coronary-artery-disease Group', 'description': 'Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.'}, {'id': 'OG001', 'title': 'Coronary-artery-disease Group', 'description': 'Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.08', 'spread': '6.48', 'groupId': 'OG000'}, {'value': '66.79', 'spread': '6.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Before surgery 5 minutes', 'description': 'Participants will be extracted 3ml blood before surgery 5 minutes,detection MIF concentration on two groups.We hypothesis that the experimental group will be higher than control group.', 'unitOfMeasure': 'MIF Concentration,ug/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants drawn from hospital inpatient cardiovascular medicine between June 2012-January 2013.This analysis was per protocol, but not intention to treat.Because the number of CHD group is less than the normal group during hospitalization.'}, {'type': 'SECONDARY', 'title': 'Comparison the Change of MIF Before and After Percutaneous Coronary Intervention （PCI） at the Patients Who Are Acute Coronary Syndromes and Stable Ischemic Heart Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Before Surgery 5 Minutes', 'description': 'Participants, who are diagnosed as coronary-artery-disease with acute coronary syndromes or stable ischemic heart disease,they Were undergoing PCI.'}, {'id': 'OG001', 'title': 'After Surgery 5 Minutes', 'description': 'Participants, who are diagnosed as coronary-artery-disease with acute coronary syndromes or stable ischemic heart disease,they Were undergoing PCI.'}, {'id': 'OG002', 'title': '5 Minutes After the Opening of the Balloon', 'description': 'Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.51', 'spread': '6.44', 'groupId': 'OG000'}, {'value': '85.40', 'spread': '7.18', 'groupId': 'OG001'}, {'value': '84.7', 'spread': '5.21', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 times including before surgery 5 minutes, 5 minutes after the opening of the balloon and after surgery 5 minutes', 'description': 'Percutaneous Coronary Intervention are extracted 3 times including before surgery 5 minutes , 5 minutes after the opening of the balloon and after surgery 5 minutes ,and detection MIF concentration .', 'unitOfMeasure': 'MIF Concentration , ug/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Coronary-artery-disease Group does not include myocardial infarction, 21 patients were acute myocardial infarction participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Comparison With MIF-173G/C Genotypes of CHD Patients and Controls.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Coronary-artery-disease Group', 'description': 'Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.'}, {'id': 'OG001', 'title': 'Non-coronary-artery-disease Group', 'description': 'Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.'}], 'classes': [{'title': 'Genotypes of CC', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Genotypes of CG', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Genotypes of GG', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before surgery', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Comparison of MIF-173G/C Alleles of CHD Patients and Controls.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-coronary-artery-disease Group', 'description': 'Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.'}, {'id': 'OG001', 'title': 'Coronary-artery-disease Group', 'description': 'Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.'}], 'classes': [{'title': 'alleles of G', 'categories': [{'measurements': [{'value': '316', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}, {'title': 'alleles of C', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before surgery', 'unitOfMeasure': 'alleles', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants drawn from hospital inpatient cardiovascular medicine between June 2012-January 2013.This analysis was per protocol, but not intention to treat.Because the number of CHD group is less than the normal group during hospitalization.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Coronary-artery-disease Group', 'description': 'Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.'}, {'id': 'FG001', 'title': 'Non-coronary-artery-disease Group', 'description': 'Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '186'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '186'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Sequencing was carried out after polymerase chain reaction with DNA specimens from 186 volunteers without CHD and 70 patients with CHD. CHD was confirmed by Coronary Angiography (CAG).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '256', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Coronary-artery-disease Group', 'description': 'Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.'}, {'id': 'BG001', 'title': 'Non-coronary-artery-disease Group', 'description': 'Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.02', 'spread': '8.57', 'groupId': 'BG000'}, {'value': '65.9', 'spread': '10.03', 'groupId': 'BG001'}, {'value': '64.96', 'spread': '9.07', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '256', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hypertension', 'classes': [{'title': 'Hypertension', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}]}, {'title': 'Not Hypertension', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HDL-C', 'classes': [{'categories': [{'measurements': [{'value': '1.01', 'spread': '0.23', 'groupId': 'BG000'}, {'value': '0.98', 'spread': '0.22', 'groupId': 'BG001'}, {'value': '0.99', 'spread': '0.22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LDL-C', 'classes': [{'categories': [{'measurements': [{'value': '2.47', 'spread': '0.74', 'groupId': 'BG000'}, {'value': '2.4', 'spread': '1.43', 'groupId': 'BG001'}, {'value': '2.44', 'spread': '0.98', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'The biospecimen is blood that taken from cubital vein.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 256}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-17', 'studyFirstSubmitDate': '2012-11-24', 'resultsFirstSubmitDate': '2013-11-07', 'studyFirstSubmitQcDate': '2012-12-12', 'lastUpdatePostDateStruct': {'date': '2015-03-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-17', 'studyFirstPostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Comparison With MIF-173G/C Genotypes of CHD Patients and Controls.', 'timeFrame': 'Before surgery'}, {'measure': 'Comparison of MIF-173G/C Alleles of CHD Patients and Controls.', 'timeFrame': 'Before surgery'}], 'primaryOutcomes': [{'measure': 'Comparison Between Coronary-artery-disease Group and Non-coronary-artery-disease Group on MIF Concentration', 'timeFrame': 'Before surgery 5 minutes', 'description': 'Participants will be extracted 3ml blood before surgery 5 minutes,detection MIF concentration on two groups.We hypothesis that the experimental group will be higher than control group.'}], 'secondaryOutcomes': [{'measure': 'Comparison the Change of MIF Before and After Percutaneous Coronary Intervention （PCI） at the Patients Who Are Acute Coronary Syndromes and Stable Ischemic Heart Disease', 'timeFrame': '3 times including before surgery 5 minutes, 5 minutes after the opening of the balloon and after surgery 5 minutes', 'description': 'Percutaneous Coronary Intervention are extracted 3 times including before surgery 5 minutes , 5 minutes after the opening of the balloon and after surgery 5 minutes ,and detection MIF concentration .'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Heart Disease']}, 'referencesModule': {'references': [{'pmid': '28578664', 'type': 'DERIVED', 'citation': 'Qian L, Wang XY, Thapa S, Tao LY, Wu SZ, Luo GJ, Wang LP, Wang JN, Wang J, Li J, Tang JF, Ji KT. Macrophage migration inhibitory factor promoter polymorphisms (-794 CATT5-8): Relationship with soluble MIF levels in coronary atherosclerotic disease subjects. BMC Cardiovasc Disord. 2017 Jun 2;17(1):144. doi: 10.1186/s12872-017-0570-x.'}, {'pmid': '25821795', 'type': 'DERIVED', 'citation': 'Ji K, Wang X, Li J, Lu Q, Wang G, Xue Y, Zhang S, Qian L, Wu W, Zhu Y, Wang L, Liao L, Tang J. Macrophage migration inhibitory factor polymorphism is associated with susceptibility to inflammatory coronary heart disease. Biomed Res Int. 2015;2015:315174. doi: 10.1155/2015/315174. Epub 2015 Mar 4.'}]}, 'descriptionModule': {'briefSummary': 'Macrophage migration inhibitory factor (MIF) is a pleiotropic cytokine that promote the inflammatory response.In animal studies, it has been found that MIF is released in the ischaemic heart, promoting glucose uptake and protecting the heart from ischaemia-reperfusion injury.The MIF concentration, influenced by age and myocardial ischemia, have different impact on myocardial functional recovery after ischemia.Therefore, the purpose of this experiment is to study the clinical significance of MIF in patients with coronary heart disease.', 'detailedDescription': 'MIF is a pleiotropic cytokine that promote the inflammatory response. MIF is expressed in several cell types,including monocytes/macrophages, vascular smooth muscle and cardiomyocytes, and is released on stimulation from pre-formed storage pools. A foreign study reported that MIF had demonstrated to offer protection from I/R-injury by activating adenosine monophosphate-activated protein kinase (AMPK) and inhibiting c-Jun Nterminal kinase (JNK)-induced apoptosis of cardiomyocytes. In addition, animal experiments showed that MIF was reduced in aged heart compared with young heart. Coronary heart disease is a chronic ischemic disease, in which MIF may play as a protective factor during the whole procedure.\n\nWe observed individuals who will be taking coronary angiography during the hospitalization. Individuals will be assigned to coronary-artery-disease group, which included acute coronary syndromes and stable ischemic heart disease, or non-coronary-artery-disease group, according to coronary angiography. All participants will be extracted 3ml blood sample 5 minutes before coronary angiography. Coronary-artery-disease group will be taken another two blood samples, 5 minutes after the opening of the balloon and 5 minutes after the stents have been implanted, respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Second Hispital of Wenzhou Medical College outpatient and inpatient', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nControl group:\n\n1. enroll individuals who confirmed by coronary angiography without coronary heart\n2. The age between 20 and 80 years old.\n3. Alanine aminotransferase(ALT):10-55U/L, Aspartate aminotransferase(AST):0-60U/L\n4. Glucose(GLU-S):3.9-6.1mmol/L\n5. Triglycerides(TRIG):0.56-1.7mmol/L, cholesterol(CHOL):3.1-5.2mmol/L, High density lipoprotein(HDL):0.78-1.96mmol/L, High density lipoprotein(LDL):2.07-3.1mmol/L\n\nExperimental group:\n\n1. enroll individuals who confirmed by coronary angiography for coronary heart\n2. The age between 20 and 80 years old.\n3. ALT:10-55U/L,AST:0-60U/L\n4. GLU-S:3.9-6.1mmol/L\n5. TRIG:0.56-1.7mmol/L,CHOL:3.1-5.2mmol/L,HDL:0.78-1.96mmol/L,LDL:2.07-3.1mmol/L\n\nExclusion Criteria:\n\n1. Inflammatory diseases,such as rheumatoid arthritis,sepsis,asthma and acute respiratory distress syndrome.\n2. Diabetes'}, 'identificationModule': {'nctId': 'NCT01750502', 'briefTitle': 'The Clinical Diagnosis Meaning of MIF in Coronary Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Wenzhou Medical University'}, 'officialTitle': 'MIF Gene Polymorphism in Coronary Heart Disease：Clinical Meaning', 'orgStudyIdInfo': {'id': 'wenzhouhp'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'coronary-artery-disease group', 'description': 'Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.'}, {'label': 'non-coronary-artery-disease group', 'description': 'Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '325000', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Second Hispital of Wenzhou Medical College', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'overallOfficials': [{'name': 'Jifei Tang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wenzhou Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'JiFei Tang', 'investigatorAffiliation': 'Wenzhou Medical University'}}}}