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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01750502
Other study ID # wenzhouhp
Secondary ID
Status Completed
Phase N/A
First received November 24, 2012
Last updated February 17, 2015
Start date May 2012
Est. completion date November 2013

Study information

Verified date February 2015
Source Wenzhou Medical University
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 256
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 90 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
China Second Hispital of Wenzhou Medical College Wenzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Comparison With MIF-173G/C Genotypes of CHD Patients and Controls. Before surgery No
Other Comparison of MIF-173G/C Alleles of CHD Patients and Controls. Before surgery No
Primary Comparison Between Coronary-artery-disease Group and Non-coronary-artery-disease Group on MIF Concentration 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. Before surgery 5 minutes No
Secondary 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 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 . 3 times including before surgery 5 minutes, 5 minutes after the opening of the balloon and after surgery 5 minutes No
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