Coronary Heart DiseaseNCT01750502
The Clinical Diagnosis Meaning of MIF in Coronary Heart Disease
An observational study of Coronary Heart Disease, run by Wenzhou Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Coronary Heart Disease
- How many people
- 256 participants
- Where
- 1 siteChina
- Study dates
- May 2012to Nov 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Second Hispital of Wenzhou Medical College outpatient and inpatient
Who may be able to join
- Control group:
- enroll individuals who confirmed by coronary angiography without coronary heart
- The age between 20 and 80 years old.
- Alanine aminotransferase(ALT):10-55U/L, Aspartate aminotransferase(AST):0-60U/L
- Glucose(GLU-S):3.9-6.1mmol/L
- 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
Show all 12Show fewer
- Experimental group:
- enroll individuals who confirmed by coronary angiography for coronary heart
- The age between 20 and 80 years old.
- ALT:10-55U/L,AST:0-60U/L
- GLU-S:3.9-6.1mmol/L
- TRIG:0.56-1.7mmol/L,CHOL:3.1-5.2mmol/L,HDL:0.78-1.96mmol/L,LDL:2.07-3.1mmol/L
Who cannot join
- Inflammatory diseases,such as rheumatoid arthritis,sepsis,asthma and acute respiratory distress syndrome.
- Diabetes
Trial locations and contacts
1 site in 1 country.
China1 site
Second Hispital of Wenzhou Medical College
Wenzhou, Zhejiang, 325000
About this study
Official title: MIF Gene Polymorphism in Coronary Heart Disease：Clinical Meaning
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.
Read the 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.
- Conditions
- Coronary Heart Disease
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before surgery 5 minutes
Secondary outcomes (1)
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 .
Measured: 3 times including before surgery 5 minutes, 5 minutes after the opening of the balloon and after surgery 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startMay 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JiFei Tang, Wenzhou Medical University
- Investigators
- Jifei Tang, MD, Principal investigator, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750502
- Sponsor's protocol ID
- wenzhouhp
- Status last verified
- Feb 2015
- First submitted
- 24 Nov 2012
- Last updated
- 4 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 28578664Ji 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.
PubMed 25821795
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIF Gene Polymorphism in Coronary Heart Disease：Clinical Meaning
- ClinicalTrials.gov ID
- NCT01750502
- Acronym / sponsor ID
- wenzhouhp
- Conditions
- Coronary Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Posted 4 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Second Hispital of Wenzhou Medical College outpatient and inpatient
Key inclusion criteria (12 listed)
- enroll individuals who confirmed by coronary angiography without coronary heart
- The age between 20 and 80 years old.
- Alanine aminotransferase(ALT):10-55U/L, Aspartate aminotransferase(AST):0-60U/L
- Glucose(GLU-S):3.9-6.1mmol/L
- 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
Key exclusion criteria (2 listed)
- Inflammatory diseases,such as rheumatoid arthritis,sepsis,asthma and acute respiratory distress syndrome.
- Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28578664Qian 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.
- Derived from this study: PubMed 25821795Ji 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.
Related trials for Coronary Heart Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jifei Tang, MD principal investigator
Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease, run by Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison Between Coronary-artery-disease Group and Non-coronary-artery-disease Group on MIF Concentration (time frame: Before surgery 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01750502, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2015.