Carotid Artery DiseasesCLASTNCT02450721
Clinical and Laboratory Biomarkers in Patients With Atherothrombotic Stroke
An observational study of Carotid Artery Diseases and Stroke, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
Trial summary
Aim of the present study is to investigate molecular and clinical markers in patients with atherosclerotic carotid stenosis (ACAS) in the ischemic stroke acute phase. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Carotid Artery Diseases, Stroke
- What is being tested?
- Biomarkers serum level measurement
- How many people
- 97 participants
- Where
- 1 siteRussia
- Study dates
- Jan 2011to Jan 2018
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In-hospital patients
Who may be able to join
- 50-99% atherosclerotic carotid artery stenosis
- Acute atherothrombotic stroke/TIA (according to TOAST-criteria) within the first 3 days after vascular event
- 50-99% atherosclerotic carotid artery stenosis
- no history of vascular events during one month before enrollment
- intima media thickness less then 1mm
- no history of stroke/TIAs
Who cannot join
- risk factors of non-atherothrombotic stroke (according to TOAST-criteria)
- cancer
- exacerbation of decompensated chronic diseases
- infections
- acute cardiovascular diseases
- large operation during 1 month before enrollment
Show all 23Show fewer
- Cortexin, Actovegin, Cerebrolysin, Erythropoetin administration during 1 week before enrollment.
- Stable ACAS
- risk factors of non-atherothrombotic stroke (according to TOAST-criteria)
- cancer
- exacerbation of decompensated chronic diseases
- infections
- acute cardiovascular diseases
- large operation during 1 month before enrollment
- Cortexin, Actovegin, Cerebrolysin, Erythropoetin administration during 1 week before enrollment.
- Control group
- risk factors of non-atherothrombotic stroke (according to TOAST-criteria)
- cancer
- exacerbation of decompensated chronic diseases
- infections
- acute cardiovascular diseases
- large operation during 1 month before enrollment
- Cortexin, Actovegin, Cerebrolysin, Erythropoetin administration during 1 week before enrollment.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
StPetersburgSPMU
Saint Petersburg, Sankt-Peterburg, 197022
Elena V. Melnikova, MD, Ph.D, +7117431508, melnikovae2002@gmail.com
Alexey A. Shmonin, Ph.D, +79213568136, langendorff@gmail.com
About this study
Aim of the present study is to investigate molecular and clinical markers in patients with atherosclerotic carotid stenosis (ACAS) in the ischemic stroke acute phase.
Read the detailed description
Background: Laboratory biomarkers of atherosclerosis can be valuable in decision about operative treatment in patients with mild to severe atherosclerotic carotid stenosis (ACAS) and high stroke risk. However nowadays there are no established instruments for personalized atherothrombotic stroke diagnostics. Aim of the present study was to access atherosclerosis biomarkers serum levels in patients with ACAS during the ischemic stroke/ transient ischemic attack (TIA) acute phase.
Main objective of the study To explore informative biomarkers to determine the risk of stroke in patients with significant ACAS.
Secondary objectives
- To investigate the association between the degree of neurological and cognitive deficits , the features of the disease , the severity of brain lesions according to neuroimaging data with the concentration of lipoprotein -associated phospholipase A2 (LP-PL-A2), high sensitive C- reactive protein (hsCRP) , pregnancy-associated plasma protein A (PAPP-A), asymmetric dimethylarginine (ADMA), lipoprotein (a) in patients with atherothrombotic stroke.
- To find the most valuable laboratory biomarkers of atherosclerosis , to compare them with clinical and objective data to make decision about inclusion of these biomarkers in routine practice as a screening test of atherosclerotic plaque instability and for stroke risk prediction and in decision about operative treatment in patients with ACAS.
Design and Methods A single-blind cross-sectional trial was performed to investigate laboratory biomarkers of atherosclerosis in patients with atherosclerotic stenosis of the internal carotid artery 50-99 % , and in healthy volunteers. Randomizing and blinding technique: laboratory scientist and statistician do not have information about the belonging of biomaterials patient to any of the groups studied .
Examination of patients includes history taking, neurological examination, duplex ultrasound, mini mental score examination (MMSE), enzyme-linked immunosorbent assay (ELISA) performed atherosclerosis biomarkers serum level measurement (LP-PL-A2, PAPP-A, ADMA, hsCRP and blood lipid profile).
- Conditions
- Carotid Artery Diseases, Stroke
- Being tested
- Biomarkers serum level measurement
- Keywords
- atherosclerosis, biomarkers, carotid artery stenosis, ischemic stroke.
- Medical subject headings
- Carotid Artery Diseases, Stroke, Atherosclerosis, Carotid Stenosis, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarkers serum level measurementOther
Biomarker serum level measurement was performed with ELISA using following kits: Lp-PL-A2 ELISA- "Cloud-CloneCorp." (USA); PAPP-A ELISA- "IBL" (Germany); Lp (a) ELISA Kit-"AssayPro" (USA ), ADMA ELISA Kit- "ImmunDiagnostik" ( Germany); hsCRP ELISA- "Biomerica" (Germany); according to the manufacturer's instructions . Absorbance of standards and samples was measured with a microplate reader "Bio-Tek" (USA) at a wavelength specified by the kit manufacturer . The calculation of the determined biomarkers concentration was performed using the software SOFTmaxPRO.
| Study group | Role | What they receive |
|---|---|---|
| Acute stroke | Patients in the acute phase of atherothrombotic stroke or TIAs with 50-99% ACAS within the first 3 days af vascular event.
Interventions to be administered: Biomarkers serum level measurement, history taking, neurological examination, duplex ultrasound, MMSE, National Institutes of Health Stroke Scale (NIHSS) Receives: Other: Biomarkers serum level measurement | |
| Stable carotid artery stenosis | Patients with 50-99% ACAS without history of vascular events during one month before enrollment.
Interventions to be administered: Biomarkers serum level measurement, history taking, neurological examination, duplex ultrasound, MMSE Receives: Other: Biomarkers serum level measurement | |
| Control group | Healthy volunteers without ACAS Interventions to be administered:Biomarkers serum level measurement, history taking, neurological examination, duplex ultrasound, MMSE Receives: Other: Biomarkers serum level measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean concentration of Lipoprotein-associated Phospholipase A2 (LP-PL-A2)
Measured: 0 month
Mean concentration of Pregnancy-associated Plasma Protein A (PAPP A)
Measured: 0 month
Mean concentration of Asymmetric Dimethylarginine (ADMA)
Measured: 0 month
Mean concentration of highsensitivity C-reactive Protein (hsCRP)
Measured: 0 month
Mean concentration of Lipprotein (a)
Measured: 0 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startJan 2011
- Primary completionJan 2015
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery DiseasesStudies 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
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450721
- Sponsor's protocol ID
- StPetersburgSPMU
- Acronym
- CLAST
- Status last verified
- May 2016
- First submitted
- 19 May 2015
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Laboratory Biomarkers in Patients With Atherothrombotic Stroke
- ClinicalTrials.gov ID
- NCT02450721
- Acronym / sponsor ID
- CLAST / StPetersburgSPMU
- Conditions
- Carotid Artery Diseases, Stroke
- Keywords
- atherosclerosis, biomarkers, carotid artery stenosis, ischemic stroke.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2018 (estimated)
- First posted
- 21 May 2015 (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.
Aim of the present study is to investigate molecular and clinical markers in patients with atherosclerotic carotid stenosis (ACAS) in the ischemic stroke acute phase.
Detailed description
Background: Laboratory biomarkers of atherosclerosis can be valuable in decision about operative treatment in patients with mild to severe atherosclerotic carotid stenosis (ACAS) and high stroke risk. However nowadays there are no established instruments for personalized atherothrombotic stroke diagnostics. Aim of the present study was to access atherosclerosis biomarkers serum levels in patients with ACAS during the ischemic stroke/ transient ischemic attack (TIA) acute phase.
Main objective of the study To explore informative biomarkers to determine the risk of stroke in patients with significant ACAS.
Secondary objectives
- To investigate the association between the degree of neurological and cognitive deficits , the features of the disease , the severity of brain lesions according to neuroimaging data with the concentration of lipoprotein -associated phospholipase A2 (LP-PL-A2), high sensitive C- reactive protein (hsCRP) , pregnancy-associated plasma protein A (PAPP-A), asymmetric dimethylarginine (ADMA), lipoprotein (a) in patients with atherothrombotic stroke.
- To find the most valuable laboratory biomarkers of atherosclerosis , to compare them with clinical and objective data to make decision about inclusion of these biomarkers in routine practice as a screening test of atherosclerotic plaque instability and for stroke risk prediction and in decision about operative treatment in patients with ACAS.
Design and Methods A single-blind cross-sectional trial was performed to investigate laboratory biomarkers of atherosclerosis in patients with atherosclerotic stenosis of the internal carotid artery 50-99 % , and in healthy volunteers. Randomizing and blinding technique: laboratory scientist and statistician do not have information about the belonging of biomaterials patient to any of the groups studied .
Examination of patients includes history taking, neurological examination, duplex ultrasound, mini mental score examination (MMSE), enzyme-linked immunosorbent assay (ELISA) performed atherosclerosis biomarkers serum level measurement (LP-PL-A2, PAPP-A, ADMA, hsCRP and blood lipid profile).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute stroke | – | Other: Biomarkers serum level measurementPatients in the acute phase of atherothrombotic stroke or TIAs with 50-99% ACAS within the first 3 days af vascular event. Interventions to be administered: Biomarkers serum level measurement, history taking, neurological examination, duplex ultrasound, MMSE, National Institutes of Health Stroke Scale (NIHSS) |
| Stable carotid artery stenosis | – | Other: Biomarkers serum level measurementPatients with 50-99% ACAS without history of vascular events during one month before enrollment. Interventions to be administered: Biomarkers serum level measurement, history taking, neurological examination, duplex ultrasound, MMSE |
| Control group | – | Other: Biomarkers serum level measurementHealthy volunteers without ACAS Interventions to be administered:Biomarkers serum level measurement, history taking, neurological examination, duplex ultrasound, MMSE |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In-hospital patients
Key inclusion criteria (6 listed)
- 50-99% atherosclerotic carotid artery stenosis
- Acute atherothrombotic stroke/TIA (according to TOAST-criteria) within the first 3 days after vascular event
- 50-99% atherosclerotic carotid artery stenosis
- no history of vascular events during one month before enrollment
- intima media thickness less then 1mm
Key exclusion criteria (23 listed)
- risk factors of non-atherothrombotic stroke (according to TOAST-criteria)
- cancer
- exacerbation of decompensated chronic diseases
- infections
- acute cardiovascular diseases
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 |
|---|---|---|
| Biomarkers serum level measurementBiomarker serum level measurement was performed with ELISA using following kits: Lp-PL-A2 ELISA- "Cloud-CloneCorp." (USA); PAPP-A ELISA- "IBL" (Germany); Lp (a) ELISA Kit-"AssayPro" (USA ), ADMA ELISA Kit- "ImmunDiagnostik" ( Germany); hsCRP ELISA- "Biomerica" (Germany); according to the manufacturer's instructions . Absorbance of standards and samples was measured with a microplate reader "Bio-Tek" (USA) at a wavelength specified by the kit manufacturer . The calculation of the determined biomarkers concentration was performed using the software SOFTmaxPRO. | Other | Acute stroke, Control group, Stable carotid artery stenosis |
Primary outcome
Mean concentration of Lipoprotein-associated Phospholipase A2 (LP-PL-A2)
Time frame: 0 month
Mean concentration of Pregnancy-associated Plasma Protein A (PAPP A)
Time frame: 0 month
Mean concentration of Asymmetric Dimethylarginine (ADMA)
Time frame: 0 month
Mean concentration of highsensitivity C-reactive Protein (hsCRP)
Time frame: 0 month
Mean concentration of Lipprotein (a)
Time frame: 0 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
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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.
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 Carotid Artery Diseases and Stroke, run by St. Petersburg State Pavlov Medical University 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 6 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 4 May 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena V. Melnikova, Ph.D. (+79117431508, melnikovae2002@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean concentration of Lipoprotein-associated Phospholipase A2 (LP-PL-A2) (time frame: 0 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2016.