NCT02450721

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

May 4, 2016

Status Verified

May 1, 2016

Enrollment Period

4 years

First QC Date

May 19, 2015

Last Update Submit

May 3, 2016

Conditions

Carotid Artery DiseasesStroke

Keywords

atherosclerosisbiomarkerscarotid artery stenosisischemic stroke.

Outcome Measures

Primary Outcomes (5)

  • Mean concentration of Lipoprotein-associated Phospholipase A2 (LP-PL-A2)

    0 month

  • Mean concentration of Pregnancy-associated Plasma Protein A (PAPP A)

    0 month

  • Mean concentration of Asymmetric Dimethylarginine (ADMA)

    0 month

  • Mean concentration of highsensitivity C-reactive Protein (hsCRP)

    0 month

  • Mean concentration of Lipprotein (a)

    0 month

Study Arms (3)

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)

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

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

Other: Biomarkers serum level measurement

Interventions

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.

Acute strokeControl groupStable carotid artery stenosis

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In-hospital patients

You may qualify if:

  • % atherosclerotic carotid artery stenosis
  • Acute atherothrombotic stroke/TIA (according to TOAST-criteria) within the first 3 days after vascular event

You may not qualify if:

  • 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.
  • Stable ACAS
  • % atherosclerotic carotid artery stenosis
  • no history of vascular events during one month before enrollment
  • risk factors of non-atherothrombotic stroke (according to TOAST-criteria)
  • cancer
  • exacerbation of decompensated chronic diseases
  • infections
  • acute cardiovascular diseases
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

StPetersburgSPMU

Saint Petersburg, Sankt-Peterburg, 197022, Russia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood serum

MeSH Terms

Conditions

Carotid Artery DiseasesStrokeAtherosclerosisCarotid StenosisIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive Diseases

Central Study Contacts

Elena V. Melnikova, Ph.D.

CONTACT

+79117431508melnikovae2002@gmail.com

Alexey A. Shmonin, Ph.D.

CONTACT

+79213568136langendorff@gmail.com

Study Design

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

Study Record Dates

First Submitted

May 19, 2015

First Posted

May 21, 2015

Study Start

January 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2018

Last Updated

May 4, 2016

Record last verified: 2016-05

Locations

RU(1)