Monocyte Activation in Preclinical Atherosclerosis

NCT02126280 | Completed DMC

• 1 other identifier: IAR-MAPA
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

The study of proinflammatory and anti-inflammatory cytokines and chemokines expression profiles in human monocytes to identify new effective biomarkers that have the best diagnostic potential in asymptomatic atherosclerosis.

Conditions

Atherosclerosis

Keywords

proinflammatory cytokines; anti-inflammatory cytokines; human monocytes; activation; biomarkers; asymptomatic atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Development and optimization of the method of monocyte-macrophage isolation.

  Technique for isolation/separation of monocytes with culture purity more than 95 % CD14-positive cells according to flow cytometry, the share of viable cells at least 98% by trypan blue vital staining, capable of producing TNFa at concentration of at least 50 pg/ml when stimulated with 100 ng/ml IFN-gamma, and CCL18 at concentration at least 30 pg/ml when stimulated with 10 ng/ml interleukin.

  up to 1 years

Secondary Outcomes (1)

• Sample processing and parameter measurements.

  up to 1 years

Study Arms (3)

Subclinical atherosclerosis

In vitro estimation of individual reactivity of monocytes in study participants with asymptomatic atherosclerotic plaques found in carotid arteries by ultrasound examination

Other: In vitro estimation of individual reactivity of monocytes

Healthy subjects

In vitro estimation of individual reactivity of monocytes in study participants without ultrasound signs of subclinical carotid atherosclerosis

Other: In vitro estimation of individual reactivity of monocytes

Diffuse intimal thickening

In vitro estimation of individual reactivity of monocytes in study participants with diffuse intima-media thickening of carotid arteries found at ultrasound examination

Other: In vitro estimation of individual reactivity of monocytes

Interventions

In vitro estimation of individual reactivity of monocytes OTHER

Technique for isolation/separation of monocytes with culture purity more than 95 % CD14-positive cells according to flow cytometry, the share of viable cells at least 98% by trypan blue vital staining, capable of producing TNFa at concentration of at least 50 pg/ml when stimulated with 100 ng/ml IFN-gamma, and CCL18 at concentration at least 30 pg/ml when stimulated with 10 ng/ml interleukin.

Diffuse intimal thickening; Healthy subjects; Subclinical atherosclerosis

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The inclusion of healthy individuals, of apparently healthy persons with a predisposition to atherosclerosis, and subjects with subclinical atherosclerosis, according to the results of ultrasonographic examination of carotids, to achieve 80% statistical power (up to 50 study participants per group). Conducting experiments on obtaining the individual cultures of blood monocytes and stimulation of cells by proinflammatory and anti-inflammatory stimuli

You may qualify if:

• men and women aged 40 to 74 years
• arterial normotension or mild arterial hypertension (systolic blood pressure \<160 mm Hg, diastolic blood pressure \<90 mm Hg)
• absence of chronic diseases demanding permanent drug administration (more than 2 month per year)

You may not qualify if:

• personal history of transient ischemic attacks
• personal history of chronic diseases demanding permanent drug administration (more than 2 month per year)
• personal history of life-threatening diseases
• indications for surgical treatment of atherosclerotic lesions localized in the extracranial brachiocephalic system

Sponsors & Collaborators

• Institute for Atherosclerosis Research, Russia: lead

Study Sites (1)

Institute for Atherosclerosis Research

Moscow, 121609, Russia

Location

Related Publications (2)

• Gratchev A, Ovsiy I, Manousaridis I, Riabov V, Orekhov A, Kzhyshkowska J. Novel monocyte biomarkers of atherogenic conditions. Curr Pharm Des. 2013;19(33):5859-64. doi: 10.2174/1381612811319330004.

  PMID: 23438959 BACKGROUND

• Gratchev A, Sobenin I, Orekhov A, Kzhyshkowska J. Monocytes as a diagnostic marker of cardiovascular diseases. Immunobiology. 2012 May;217(5):476-82. doi: 10.1016/j.imbio.2012.01.008. Epub 2012 Jan 13.

  PMID: 22325375 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood taken with anticoagulants for immediate monocyte isolation to be seeded in cell culture, and for preparation of plasma samples to be frozen for lipid analysis.

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alexander N Orekhov, PhD, DSc

  Institute for Atherosclerosis Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2014
• First Posted: April 30, 2014
• Study Start: November 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 30, 2014

Record last verified: 2014-04

Locations

RU (1)