- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02896543
The Relationship of Change of Dendritic Cells Fractalkine and P-selectin Patients With Acute Myocardial Infarction
July 29, 2017 updated by: Rchuang, The First Affiliated Hospital of Dalian Medical University
The Relationship of Change of Dendritic Cells Fractalkine and P-selectin in Patients With Acute Myocardial Infarction
This study evaluates the relationship of change of dendritic cells fractalkine and P-selectin in patients with acute myocardial infarction.
Study Overview
Detailed Description
Dendritic cells (DCs) are the most potent antigen-presenting cells, with the unique ability to initiate a primary immune response to certain antigens by activation of "naive" T cells, and are actively related to the process of atherosclerosis.
Two DC subsets, myeloid DCs (mDCs) and plasmacytoid DCs (pDCs), were identified in humans.
In our previous study, the investigators found that change of dendritic cells and fractalkine in patients with acute myocardial infarction.
At the same time, the level of P-selectin increased.
In addition, the interaction of dendritic cells and P-selectin promotes the progress of atherosclerosis.
In this study, the investigators want to see whether the balance between mDCs and pDCs is altered in patients with acute myocardial infarction.
sP-selectin is one of the members of the family of proteins, mediate leukocyte adhesion and rolling in vascular endothelial, studies have shown that in patients with unstable angina and acute myocardial infarction in serum sP-selectin protein increased significantly, showed that sP-selectin associated with the activity of coronary heart disease, causing plaque instability.However, there is few relevant studies about the relationship of dendritic cells and P-selectin in patients with acute myocardial infarction.
This study valuates the relationship of dendritic cells and P-selectin in patients with acute myocardial infarction
Study Type
Observational
Enrollment (Actual)
45
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Liaoning
-
Dalian, Liaoning, China, 116011
- The First Affiliated Hospital of Dalian Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients with STEMI.
Description
Inclusion Criteria:
- diagnosed as STEMI.
- with left ventricular ejection fraction(LVEF)>=45%
- written informed consents are obtained.
- admitted within 24 hours after chest pain attacked.
Exclusion Criteria:
- Obvious blood system diseases.
- Combination with other organs function failure: severe liver dysfunction, severe renal insufficiency,severe heart failure (NYHA class 3 and 4), acute or chronic infectious diseases, disease of immune system, asthma, malignant tumor, other advanced disease, etc.
- Pregnant women and planned pregnancy women.
- With drug allergy or contraindications.
- refusal to sign the informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
STEMI group
The study population consists of 30 patients with ST-elevated acute myocardial infarction (STEMI,n = 30) who are admitted within 24 hours after chest pain attacks.
They will all undergo coronary angiography.The diagnosis is made according to American Heart Association (AHA, 2014 and 2015) guidelines.
Patients who had obvious blood system diseases,severe liver dysfunction, severe renal insufficiency,severe heart failure (NYHA class 3 and 4), acute or chronic infectious diseases, disease of immune system, asthma, malignant tumor, other advanced disease are excluded.
|
Blood is obtained into ethylene diamine tetraacetic acid(EDTA) tubes from all subjects via antecubital vein puncture to measure the number of dendritic cells(DCs) and the concentration of sP-selectin.
The number of dendritic cells(DCs) and the concentration of sP-selectin are measured in all patients with STEMI at 0 and 5-7 days after admission.
The number of dendritic cells(DCs) and the only once in control group after admission.
|
Control group
15 age and body mass index matched healthy subjects with neither coronary artery disease nor any of the components of the metabolic syndrome are enrolled as Control group.
|
Blood is obtained into ethylene diamine tetraacetic acid(EDTA) tubes from all subjects via antecubital vein puncture to measure the number of dendritic cells(DCs) and the concentration of sP-selectin.
The number of dendritic cells(DCs) and the concentration of sP-selectin are measured in all patients with STEMI at 0 and 5-7 days after admission.
The number of dendritic cells(DCs) and the only once in control group after admission.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of dendritic cells(DCs)(percentage of total white blood cells) and the concentration of sP-selectin(ng/ml) within 24 hours after chest pain attacks
Time Frame: 24 hours
|
The number of dendritic cells(DCs) in percentage of total white blood cells;the concentration of sP-selectin in ng/ml
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of peripheral blood DCs number (percentage of total white blood cells) and its fractalkine change of peripheral blood DCs number(percentage of total white blood cells) within 1 week after chest pain attacks
Time Frame: 1 week
|
Dendritic cells(DCs) number in percentage of total white blood cells;its fractalkine change of peripheral blood DCs in percentage of total white blood cells
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Laszik Z, Jansen PJ, Cummings RD, Tedder TF, McEver RP, Moore KL. P-selectin glycoprotein ligand-1 is broadly expressed in cells of myeloid, lymphoid, and dendritic lineage and in some nonhematopoietic cells. Blood. 1996 Oct 15;88(8):3010-21.
- Hussain M, Javeed A, Ashraf M, Riaz A, Mushtaq MH. Aspirin may do wonders by the induction of immunological self-tolerance against autoimmune atherosclerosis. Med Hypotheses. 2012 Jan;78(1):171-3. doi: 10.1016/j.mehy.2011.10.019. Epub 2011 Nov 8.
- Packard RR, Lichtman AH, Libby P. Innate and adaptive immunity in atherosclerosis. Semin Immunopathol. 2009 Jun;31(1):5-22. doi: 10.1007/s00281-009-0153-8. Epub 2009 May 16.
- Kieffer JD, Fuhlbrigge RC, Armerding D, Robert C, Ferenczi K, Camphausen RT, Kupper TS. Neutrophils, monocytes, and dendritic cells express the same specialized form of PSGL-1 as do skin-homing memory T cells: cutaneous lymphocyte antigen. Biochem Biophys Res Commun. 2001 Jul 20;285(3):577-87. doi: 10.1006/bbrc.2001.5230.
- Schakel K, Kannagi R, Kniep B, Goto Y, Mitsuoka C, Zwirner J, Soruri A, von Kietzell M, Rieber E. 6-Sulfo LacNAc, a novel carbohydrate modification of PSGL-1, defines an inflammatory type of human dendritic cells. Immunity. 2002 Sep;17(3):289-301. doi: 10.1016/s1074-7613(02)00393-x.
- Bonasio R, Scimone ML, Schaerli P, Grabie N, Lichtman AH, von Andrian UH. Clonal deletion of thymocytes by circulating dendritic cells homing to the thymus. Nat Immunol. 2006 Oct;7(10):1092-100. doi: 10.1038/ni1385. Epub 2006 Sep 3. Erratum In: Nat Immunol. 2006 Nov;7(11):1234.
- Yao K, Lu H, Huang R, Zhang S, Hong X, Shi H, Sun A, Qian J, Zou Y, Ge J. Changes of dendritic cells and fractalkine in type 2 diabetic patients with unstable angina pectoris: a preliminary report. Cardiovasc Diabetol. 2011 Jun 10;10:50. doi: 10.1186/1475-2840-10-50.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
July 6, 2016
First Submitted That Met QC Criteria
September 6, 2016
First Posted (Estimate)
September 12, 2016
Study Record Updates
Last Update Posted (Actual)
August 1, 2017
Last Update Submitted That Met QC Criteria
July 29, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCKY2016-6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Myocardial Infarction
-
Henry Ford Health SystemAbiomed Inc.Enrolling by invitationAcute Myocardial Infarction | Cardiogenic Shock | STEMI | NSTEMI - Non-ST Segment Elevation MI | STEMI - ST Elevation Myocardial Infarction | NSTEMI | Acute Myocardial Infarction With ST Elevation | Acute Myocardial Infarction of Right Ventricle (Disorder) | Acute Myocardial Infarction of Left VentricleUnited States
-
Jordan Collaborating Cardiology GroupCardiovascular Academy GroupTerminatedTriggers of Acute Myocardial Infarction | Time of Onset of Acute Myocardial Infarction | Long-term Prognosis After Acute Myocardial InfarctionJordan
-
Recardio, Inc.CompletedAcute Myocardial Infarction | STEMI - ST Elevation Myocardial Infarction | Acute Myocardial IschemiaNetherlands, Hungary, Austria, Poland, Belgium
-
Medical Center of South ArkansasWithdrawnAcute Coronary Syndrome | Acute ST Segment Elevation Myocardial InfarctionUnited States
-
Yuan's General HospitalKaohsiung Veterans General Hospital.; Sin-Lau HospitalUnknownAcute Myocardial Infarction, of Inferolateral Wall | Acute Myocardial Infarction, of Inferoposterior WallTaiwan
-
Aristotle University Of ThessalonikiRecruitingCardiovascular Diseases | Acute Coronary Syndrome | Acute Myocardial Infarction | Metabolic DisturbanceGreece
-
Barts & The London NHS TrustUniversity College, London; Queen Mary University of LondonCompletedAcute Myocardial InfarctionSwitzerland, Denmark, United Kingdom
-
Sheba Medical CenterCompletedNon ST Elevation Myocardial Infarction | Acute Coronary SyndromesIsrael
-
Medstar Health Research InstituteWithdrawnST-elevation Myocardial Infarction | Acute Myocardial InfarctionUnited States
-
Hennepin Healthcare Research InstituteSiemens HealthineersActive, not recruitingAcute Coronary Syndrome | Acute Myocardial InfarctionUnited States
Clinical Trials on measurement
-
University Hospital, Clermont-FerrandCompletedCoronary Artery Disease | Coronary Artery Bypass | Pulmonary Atelectasis | Anesthesia, General | HypovolemiaFrance
-
Hasselt UniversityTRACE labs Ziekenhuis Oost-Limburg (ZOL)RecruitingBurnout, Psychological | FibromyalgiaBelgium
-
Ain Shams UniversityUnknown
-
Kutahya Health Sciences UniversityRecruiting
-
Hasselt UniversityTRACE labs Ziekenhuis Oost-Limburg (ZOL)Recruiting
-
Medical University of GrazNot yet recruitingDelirium | Critical IllnessAustria
-
Istanbul Medeniyet UniversityNot yet recruiting
-
Centre Hospitalier Universitaire Saint PierreMasimo Corporation; Centre Hospitalier Universitaire BrugmannCompletedOut-Of-Hospital Cardiac Arrest | Oxygen ToxicityBelgium
-
Southeast University, ChinaUnknownEndothelial Dysfunction | ARDS, Human | Mechanical Ventilation Pressure HighChina
-
Ankara City Hospital BilkentCompletedHypothermia | Orthopedic Disorder | Hip ArthropathyTurkey