AtherosclerosisMAPANCT02126280
Monocyte Activation in Preclinical Atherosclerosis
An observational study of Atherosclerosis, run by Institute for Atherosclerosis Research, Russia at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- In vitro estimation of individual reactivity of monocytes
- How many people
- 170 participants
- Where
- 1 siteRussia
- Study dates
- Nov 2012to Apr 2014
- 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 40 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross-sectional Clinical Study of the Individual Profile of Activation of Circulating Blood Monocytes in Subjects With Preclinical Atherosclerosis.
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.
Read the detailed description
This project is the first step in creating a method for assessing an individual activity of macrophages. The problems addressed in the project are socially significant because of the high incidence of life-threatening diseases and their effects in the population. The method of evaluation of monocyte-macrophages activity in human blood will be based on the analysis of expression of cytokines and chemokines - markers of inflammatory and anti-inflammatory activity of macrophages. The most informative panel of cytokines and chemokines obtained during the project can be further used to create effective diagnostic tests.
- Conditions
- Atherosclerosis
- Being tested
- In vitro estimation of individual reactivity of monocytes
- Keywords
- proinflammatory cytokines, anti-inflammatory cytokines, human monocytes, activation, biomarkers, asymptomatic atherosclerosis
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In vitro estimation of individual reactivity of monocytesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Subclinical atherosclerosis | In vitro estimation of individual reactivity of monocytes in study participants with asymptomatic atherosclerotic plaques found in carotid arteries by ultrasound examination Receives: 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 Receives: 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 Receives: Other: In vitro estimation of individual reactivity of monocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1 years
Secondary outcomes (1)
Sample processing and parameter measurements.
Creating a collection of samples of the culture medium during cell stimulation into pro-inflammatory or anti-inflammatory phenotype.
Definition of individual profiles of cell activation by the production of proinflammatory and anti-inflammatory cytokines and chemokines (C5a, IL-4, IL-32 alpha, CD40 ligand, IL-5, CXCL10, G-CSF, IL-6, CXCL11/I-TAC, GM-CSF , IL-8, CCL2, CXCL1, IL-10, MIF, CCL1, IL-12 p70, CCL3, ICAM-1, IL-13, CCL4, IFN-gamma, IL-16, CCL5, IL-1 alpha, IL -17, CXCL12, IL-1 beta, IL-17E, Serpin E1, IL-1ra, TNF-alpha, IL-2, IL-27, and TREM-1).
Database generation on individual reactivity of monocytes-macrophages from healthy donors, individuals predisposed to atherosclerosis, and patients with asymptomatic atherosclerosis.
Creating a collection of samples. Determination of concentrations of pro-inflammatory and anti-inflammatory markers.
Measured: up to 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startNov 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Atherosclerosis Research, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander N Orekhov, PhD, DSc, Principal investigator, Institute for Atherosclerosis Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126280
- Sponsor's protocol ID
- IAR-MAPA
- Acronym
- MAPA
- Status last verified
- Apr 2014
- First submitted
- 23 Apr 2014
- Last updated
- 30 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23438959Gratchev 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.
PubMed 22325375
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Clinical Study of the Individual Profile of Activation of Circulating Blood Monocytes in Subjects With Preclinical Atherosclerosis.
- ClinicalTrials.gov ID
- NCT02126280
- Acronym / sponsor ID
- MAPA / IAR-MAPA
- Conditions
- Atherosclerosis
- Keywords
- proinflammatory cytokines, anti-inflammatory cytokines, human monocytes, activation, biomarkers, asymptomatic atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Institute for Atherosclerosis Research, RussiaUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This project is the first step in creating a method for assessing an individual activity of macrophages. The problems addressed in the project are socially significant because of the high incidence of life-threatening diseases and their effects in the population. The method of evaluation of monocyte-macrophages activity in human blood will be based on the analysis of expression of cytokines and chemokines - markers of inflammatory and anti-inflammatory activity of macrophages. The most informative panel of cytokines and chemokines obtained during the project can be further used to create effective diagnostic tests.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subclinical atherosclerosis | – | Other: In vitro estimation of individual reactivity of monocytesIn vitro estimation of individual reactivity of monocytes in study participants with asymptomatic atherosclerotic plaques found in carotid arteries by ultrasound examination |
| Healthy subjects | – | Other: In vitro estimation of individual reactivity of monocytesIn vitro estimation of individual reactivity of monocytes in study participants without ultrasound signs of subclinical carotid atherosclerosis |
| Diffuse intimal thickening | – | Other: In vitro estimation of individual reactivity of monocytesIn vitro estimation of individual reactivity of monocytes in study participants with diffuse intima-media thickening of carotid arteries found at ultrasound examination |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In vitro estimation of individual reactivity of monocytesTechnique 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. | Other | Diffuse intimal thickening, Healthy subjects, Subclinical atherosclerosis |
Primary outcome
Development and optimization of the method of monocyte-macrophage isolation.
Time frame: up to 1 years
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.
1 secondary outcome
Sample processing and parameter measurements.
Time frame: up to 1 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2014.
- Background: PubMed 23438959Gratchev 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.
- Background: PubMed 22325375Gratchev 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander N Orekhov, PhD, DSc principal investigator
Institute for Atherosclerosis Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, run by Institute for Atherosclerosis Research, Russia at 1 site in Russia.
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 3 inclusion and 4 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 30 Apr 2014. 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 Russia. 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?
Development and optimization of the method of monocyte-macrophage isolation. (time frame: up to 1 years). 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 NCT02126280, which also lists 2 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 30 Apr 2014.