Cardio-embolic Stroke and Blood Bio-markers

April 26, 2019 updated by: Wafaa Samir

Cardio-embolic Stroke and Blood Bio-markers:Diagnosis and Predictors of Short Term Outcome.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

participants and methods : 96 acute ischemic stroke 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 .

All patients were subjected to full detailed neurological history with stressing on the vascular and cardiac risk factors , and general and neurological examination. Stroke severity was assessed using Glasgow Coma Scale (GCS) and the National Institutes of Health Stroke Scale (NIHSS)

Laboratory investigations:15 ml venous blood were obtained from the patients within the first 24 hours of stroke. All routine and special laboratory investigations were done at Clinical pathology department, Zagazig university hospitals including CBC, liver function, kidney function, ESR and lipid profile.

Brain natriuretic peptide : 4 ml blood was placed in a polypro pane tube containing a mixture of sodium salt of ethylene diamine tetra acetic acid (EDTA) at a concentration of 1mg /ml of blood and aprotinin at a concentration of 500 kallikerin inhibitory unit (kiu) /ml of blood serving as a natural proteinase inhibitor which act as a preservative for natriuretic peptides , then mixing of the blood was done . then the tube was centrifuged at 5000 rpm for 15 minutes in the cool centrifuge , the separated serum was stored at -70 degree c until analysis.

Later on the assay was done using human BNP Elisa kits (Spain react kits sr 19369u) which are immune-sorbent assay for quantitative measurement , the least sensitivity is 14 pg/ml and ranges 14 -1000pg/ml .

D-Dimer: 3ml blood was collected within a vacuum tubes containing 0.5 ml buffered sodium citrate before the initiation of any oral, enteral or parenteral feeding or medications. Blood samples were mixed well with avoiding of foam formation then immediately centrifuged at 3000 rpm for 15 min at ambient room temperature and plasma is separated. D-Dimer was measured turbidmetry (SAT Liatest D-Di; Diagnostica STAGO) on the STAgo compact analyzer, Normal value is less than 500 ng / ml (15).

Creatine Kinase MB : 4 ml blood were derived within a plastic tube centrifuged at 4000rpm for 3minutes , the separated serum was assayed for CK MB using Spain react kits with normal value up to 2.8ng /L C reactive protein : 4ml were withdrawn in a plastic tube centrifuged at 4000rpm for 3minutes , the separated serum used for analysis of CRP measured using Olympus 640 analyzer with normal value up to 5 mg / L Globulin/Albumin ratio( G/A) was calculated with normal ratio 0.6-0.7 . All patients were evaluated by Brain CT or MRI for diagnosis of ischemic stroke .

Each patient underwent to Electrocardiogram, Echocardiography and Carotid Doppler ultrasonography to define etiological stoke subtype.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

32 years to 87 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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

Description

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
cardioembolic stroke
Other: blood biomarkers
assessment of serum BNP, D-Dimer and CK-MB and CRP and globulin /albumin ratio stroke outcome
non cardioembolic stroke
Other: blood biomarkers
assessment of serum BNP, D-Dimer and CK-MB and CRP and globulin /albumin ratio stroke outcome

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
modified rankin scale
Time Frame: at the third week of stroke onset
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wafaa Samir

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZU-IRB# :2325/7-9-2015).

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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