NCT03927872

Brief Summary

Brain is a productive source of variety of enzymes and any brain injury like stroke to brain tissue could similarly result in an increase in these enzymes in cerebrospinal fluid and serum. Evaluation of these enzymes represent a simple method for the ischemic stroke subtype diagnosis and prognosis .Objective: The aim of this study was to determine the role Brain natriuretic peptide (BNP) , D-Dimer , creatine kinase- MB(CK-MB) , C reactive protein (CRP) serum levels and G/A ratio in diagnosis of CES stroke and its ability to predict short term outcome. Methods: This study was conducted on 96 patients with acute ischemic stroke, subdivided into two groups, group Ι was 48 patients with cardio-embolic stroke and group ΙΙ was 48 patients with non- cardio-embolic. all patients were subjected to assessment of serum BNP, D-Dimer and CK-MB and CRP and globulin /albumin ratio within the first 24 h of stroke .At third week ,they were assessed by mRS.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2019

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

3 years

First QC Date

April 23, 2019

Last Update Submit

April 26, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • modified rankin scale

    ranging from zero(no symptoms at all) to 6 (dead).outcome was defined as good if mRS=0-2,bad (poor) if mRS=3-5 and death if mRS=6

    at the third week of stroke onset

Study Arms (2)

cardioembolic stroke

Other: blood biomarkers

non cardioembolic stroke

Other: blood biomarkers

Interventions

assessment of serum BNP, D-Dimer and CK-MB and CRP and globulin /albumin ratio stroke outcome

cardioembolic strokenon cardioembolic stroke

Eligibility Criteria

Age32 Years - 87 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

96 AIS patients divided to two groups ; group Ι : 48 patients with cardio-embolic stroke (CES) and group ΙΙ: 48 patients with cerebrovascular stroke other than cardio-embolic stroke (non CES), with first-ever acute ischemic stroke within 24 h of onset of symptoms admitted to Intensive Care and Stroke Unit

You may qualify if:

  • CES and non- CES diagnosis was according to Trial of Org 10172 in Acute Stroke Treatment ﴾TOAST﴿ classification criteria.
  • non -CES were selected to match patients with CES regarding age and vascular risk factors as a control group.
  • Patients with National Institutes of Health Stroke Scale ﴾NIHSS ﴿ score more than 5.
  • Adult patients with their ages more than 18 year.

You may not qualify if:

  • Lacunar stroke and transient ischemic attacks (TIAs)
  • Haemorrhagic stroke.
  • Neurological causes of acute focal cerebral dysfunction such as cerebral venous sinus thrombosis , head trauma, infection, and auto immune disorders
  • Heart failure
  • Liver failure
  • Chronic renal disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor of neurology

Study Record Dates

First Submitted

April 23, 2019

First Posted

April 25, 2019

Study Start

October 1, 2015

Primary Completion

October 1, 2018

Study Completion

December 1, 2018

Last Updated

April 30, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share