NCT02896543

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

July 6, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

4 months

First QC Date

July 6, 2016

Last Update Submit

July 29, 2017

Conditions

Keywords

dendritic cellsP-selectin

Outcome Measures

Primary Outcomes (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

    24 hours

Secondary Outcomes (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

    1 week

Study Arms (2)

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.

Other: measurement

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.

Other: measurement

Interventions

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 groupSTEMI group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with STEMI.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

Related Publications (7)

  • 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.

  • 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.

MeSH Terms

Interventions

Weights and Measures

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 6, 2016

First Posted

September 12, 2016

Study Start

September 1, 2016

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

August 1, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations