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The Clinical Diagnosis Meaning of MIF in Coronary Heart Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01750502
First Posted: December 17, 2012
Last Update Posted: March 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
JiFei Tang, Wenzhou Medical University
  Purpose
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.

Condition
Coronary Heart Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: MIF Gene Polymorphism in Coronary Heart Disease:Clinical Meaning

Resource links provided by NLM:


Further study details as provided by JiFei Tang, Wenzhou Medical University:

Primary Outcome Measures:
  • Comparison Between Coronary-artery-disease Group and Non-coronary-artery-disease Group on MIF Concentration [ Time Frame: Before surgery 5 minutes ]
    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.


Secondary Outcome Measures:
  • 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 [ Time Frame: 3 times including before surgery 5 minutes, 5 minutes after the opening of the balloon and after surgery 5 minutes ]
    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 .


Other Outcome Measures:
  • Comparison With MIF-173G/C Genotypes of CHD Patients and Controls. [ Time Frame: Before surgery ]
  • Comparison of MIF-173G/C Alleles of CHD Patients and Controls. [ Time Frame: Before surgery ]

Biospecimen Retention:   Samples Without DNA
The biospecimen is blood that taken from cubital vein.

Enrollment: 256
Study Start Date: May 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
coronary-artery-disease group
Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
non-coronary-artery-disease group
Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.

Detailed Description:

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.

We 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.

  Eligibility

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Second Hispital of Wenzhou Medical College outpatient and inpatient
Criteria

Inclusion Criteria:

Control group:

  1. enroll individuals who confirmed by coronary angiography without coronary heart
  2. The age between 20 and 80 years old.
  3. Alanine aminotransferase(ALT):10-55U/L, Aspartate aminotransferase(AST):0-60U/L
  4. Glucose(GLU-S):3.9-6.1mmol/L
  5. 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

Experimental group:

  1. enroll individuals who confirmed by coronary angiography for coronary heart
  2. The age between 20 and 80 years old.
  3. ALT:10-55U/L,AST:0-60U/L
  4. GLU-S:3.9-6.1mmol/L
  5. TRIG:0.56-1.7mmol/L,CHOL:3.1-5.2mmol/L,HDL:0.78-1.96mmol/L,LDL:2.07-3.1mmol/L

Exclusion Criteria:

  1. Inflammatory diseases,such as rheumatoid arthritis,sepsis,asthma and acute respiratory distress syndrome.
  2. Diabetes
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750502


Locations
China, Zhejiang
Second Hispital of Wenzhou Medical College
Wenzhou, Zhejiang, China, 325000
Sponsors and Collaborators
Wenzhou Medical University
Investigators
Principal Investigator: Jifei Tang, MD Wenzhou Medical University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: JiFei Tang, Director, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT01750502     History of Changes
Other Study ID Numbers: wenzhouhp
First Submitted: November 24, 2012
First Posted: December 17, 2012
Results First Submitted: November 7, 2013
Results First Posted: March 4, 2015
Last Update Posted: March 4, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases