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Acute Myocardial InfarctionNCT02896543

The Relationship of Change of Dendritic Cells Fractalkine and P-selectin Patients With Acute Myocardial Infarction

An observational study of Acute Myocardial Infarction, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
measurement
How many people
45 participants
Where
1 siteChina
Study dates
Sep 2016to Mar 2017
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

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 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: patients with STEMI.

Who may be able to join

  • diagnosed as STEMI.
  • with left ventricular ejection fraction（LVEF）>=45%
  • written informed consents are obtained.
  • admitted within 24 hours after chest pain attacked.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116011

Other trials in China

About this study

Official title: 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.

Read the 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

Being tested
measurement
Keywords
dendritic cells, P-selectin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • measurementOther

    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.

Study groups in NCT02896543
Study groupRoleWhat they receive
STEMI groupThe 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.
Receives: Other: measurement
Control group15 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.
Receives: Other: measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 24 hours

Secondary outcomes (1)

  1. 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

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionJan 2017
  4. Study completionMar 2017

Resources

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
Case-control
Time perspective
Prospective
Enrolment
45 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02896543
Sponsor's protocol ID
LCKY2016-6
Status last verified
Jul 2017
First submitted
6 Jul 2016
Last updated
1 Aug 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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.

    PubMed 8874199

  • 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.

    PubMed 22070887

  • 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.

    PubMed 19449008

  • 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.

    PubMed 11453631

  • 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.

    PubMed 12354382

  • 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.

    PubMed 16951687

  • 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.

    PubMed 21658276

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myocardial Infarction, run by The First Affiliated Hospital of Dalian 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 4 inclusion and 5 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 1 Aug 2017. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

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). 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 NCT02896543, which also lists 7 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 1 Aug 2017.

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