NCT01750502

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2012

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 4, 2015

Completed
Last Updated

March 4, 2015

Status Verified

February 1, 2015

Enrollment Period

1.5 years

First QC Date

November 24, 2012

Results QC Date

November 7, 2013

Last Update Submit

February 17, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

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

    3 times including before surgery 5 minutes, 5 minutes after the opening of the balloon and after surgery 5 minutes

Other Outcomes (2)

  • 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

Study Arms (2)

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.

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Second Hispital of Wenzhou Medical College outpatient and inpatient

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • Inflammatory diseases,such as rheumatoid arthritis,sepsis,asthma and acute respiratory distress syndrome.
  • Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Hispital of Wenzhou Medical College

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (2)

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

The biospecimen is blood that taken from cubital vein.

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Limitations and Caveats

There are some limitations to this research. First, the sample size was relative small. Second,no participants were retrospectively analyzed.

Results Point of Contact

Title
Dr. JiFei Tang
Organization
Department of Cardiology, the Second Affiliated Hospital, Wenzhou Medical University, Zhejiang province, Wenzhou,China

Study Officials

  • Jifei Tang, MD

    Wenzhou Medical University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 24, 2012

First Posted

December 17, 2012

Study Start

May 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

March 4, 2015

Results First Posted

March 4, 2015

Record last verified: 2015-02

Locations