Coronary Heart Disease
Conditions
Brief 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.
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.
Interventions
None listed
Sponsors
Wenzhou Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison Between Coronary-artery-disease Group and Non-coronary-artery-disease Group on MIF Concentration | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame |
|---|---|
| Comparison With MIF-173G/C Genotypes of CHD Patients and Controls. | Before surgery |
| Comparison of MIF-173G/C Alleles of CHD Patients and Controls. | Before surgery |
Countries
China
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 70 |
| 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. | 186 |
| Total | 256 |
Baseline characteristics
| Characteristic | Coronary-artery-disease Group | Non-coronary-artery-disease Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 35 Participants | 46 Participants |
| Age, Categorical Between 18 and 65 years | 59 Participants | 151 Participants | 210 Participants |
| Age, Continuous | 64.02 years STANDARD_DEVIATION 8.57 | 65.9 years STANDARD_DEVIATION 10.03 | 64.96 years STANDARD_DEVIATION 9.07 |
| HDL-C | 1.01 mmol/L STANDARD_DEVIATION 0.23 | 0.98 mmol/L STANDARD_DEVIATION 0.22 | 0.99 mmol/L STANDARD_DEVIATION 0.22 |
| Hypertension Hypertension | 46 participants | 111 participants | 157 participants |
| Hypertension Not Hypertension | 24 participants | 75 participants | 99 participants |
| LDL-C | 2.47 mmol/L STANDARD_DEVIATION 0.74 | 2.4 mmol/L STANDARD_DEVIATION 1.43 | 2.44 mmol/L STANDARD_DEVIATION 0.98 |
| Region of Enrollment China | 70 participants | 186 participants | 256 participants |
| Sex: Female, Male Female | 33 Participants | 97 Participants | 130 Participants |
| Sex: Female, Male Male | 37 Participants | 89 Participants | 126 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 70 | 0 / 186 |
| serious Total, serious adverse events | 0 / 70 | 0 / 186 |
Outcome results
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.
Time frame: Before surgery 5 minutes
Population: 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.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Non-coronary-artery-disease Group | Comparison Between Coronary-artery-disease Group and Non-coronary-artery-disease Group on MIF Concentration | 48.08 MIF Concentration,ug/L | Standard Deviation 6.48 |
| Coronary-artery-disease Group | Comparison Between Coronary-artery-disease Group and Non-coronary-artery-disease Group on MIF Concentration | 66.79 MIF Concentration,ug/L | Standard Deviation 6.29 |
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 .
Time frame: 3 times including before surgery 5 minutes, 5 minutes after the opening of the balloon and after surgery 5 minutes
Population: Coronary-artery-disease Group does not include myocardial infarction, 21 patients were acute myocardial infarction participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-coronary-artery-disease Group | 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 | 85.51 MIF Concentration , ug/L | Standard Deviation 6.44 |
| Coronary-artery-disease Group | 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 | 85.40 MIF Concentration , ug/L | Standard Deviation 7.18 |
| 5 Minutes After the Opening of the Balloon | 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 | 84.7 MIF Concentration , ug/L | Standard Deviation 5.21 |
Other Pre-specified
Comparison of MIF-173G/C Alleles of CHD Patients and Controls.
Time frame: Before surgery
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-coronary-artery-disease Group | Comparison of MIF-173G/C Alleles of CHD Patients and Controls. | alleles of G | 316 alleles |
| Non-coronary-artery-disease Group | Comparison of MIF-173G/C Alleles of CHD Patients and Controls. | alleles of C | 56 alleles |
| Coronary-artery-disease Group | Comparison of MIF-173G/C Alleles of CHD Patients and Controls. | alleles of G | 106 alleles |
| Coronary-artery-disease Group | Comparison of MIF-173G/C Alleles of CHD Patients and Controls. | alleles of C | 34 alleles |
Other Pre-specified
Comparison With MIF-173G/C Genotypes of CHD Patients and Controls.
Time frame: Before surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-coronary-artery-disease Group | Comparison With MIF-173G/C Genotypes of CHD Patients and Controls. | Genotypes of CC | 10 participants |
| Non-coronary-artery-disease Group | Comparison With MIF-173G/C Genotypes of CHD Patients and Controls. | Genotypes of CG | 14 participants |
| Non-coronary-artery-disease Group | Comparison With MIF-173G/C Genotypes of CHD Patients and Controls. | Genotypes of GG | 46 participants |
| Coronary-artery-disease Group | Comparison With MIF-173G/C Genotypes of CHD Patients and Controls. | Genotypes of CC | 6 participants |
| Coronary-artery-disease Group | Comparison With MIF-173G/C Genotypes of CHD Patients and Controls. | Genotypes of CG | 44 participants |
| Coronary-artery-disease Group | Comparison With MIF-173G/C Genotypes of CHD Patients and Controls. | Genotypes of GG | 136 participants |