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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02896543
Other study ID # LCKY2016-6
Secondary ID
Status Completed
Phase N/A
First received July 6, 2016
Last updated July 29, 2017
Start date September 2016
Est. completion date March 2017

Study information

Verified date July 2017
Source The First Affiliated Hospital of Dalian Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study evaluates the relationship of change of dendritic cells fractalkine and P-selectin in patients with acute myocardial infarction.


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


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date March 2017
Est. primary completion date January 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Intervention

Other:
measurement
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.

Locations

Country Name City State
China The First Affiliated Hospital of Dalian Medical University Dalian Liaoning

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

References & Publications (7)

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. Epub 2006 Sep 3. Erratum in: Nat Immunol. 2006 Nov;7(11):123 — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. Review. — View Citation

Schäkel 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. — View Citation

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The number of dendritic cells(DCs) in percentage of total white blood cells;the concentration of sP-selectin in ng/ml 24 hours
Secondary 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 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
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