Ischemic StrokeNCT03927872
Cardio-embolic Stroke and Blood Bio-markers
An observational study of Ischemic Stroke, run by Wafaa Samir.
Trial 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. Read more about this study
- Who is it for?
- Ages 32 to 87 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- blood biomarkers
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Dec 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 32 to 87 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- blood biomarkers
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood biomarkersOther
assessment of serum BNP, D-Dimer and CK-MB and CRP and globulin /albumin ratio stroke outcome
| Study group | Role | What they receive |
|---|---|---|
| cardioembolic stroke | Not described Receives: Other: blood biomarkers | |
| non cardioembolic stroke | Not described Receives: Other: blood biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at the third week of stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study startOct 2015
- Primary completionOct 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wafaa Samir
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Wafaa Samir, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927872
- Sponsor's protocol ID
- ZU-IRB# :2325/7-9-2015).
- Status last verified
- Apr 2019
- First submitted
- 23 Apr 2019
- Last updated
- 30 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardio-embolic Stroke and Blood Bio-markers:Diagnosis and Predictors of Short Term Outcome.
- ClinicalTrials.gov ID
- NCT03927872
- Acronym / sponsor ID
- ZU-IRB# :2325/7-9-2015).
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Wafaa SamirOther government
- Study start
- Oct 2015 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 25 Apr 2019 (actual)
- 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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cardioembolic stroke | – | Other: blood biomarkers |
| non cardioembolic stroke | – | Other: blood biomarkers |
Who may qualify
- Ages
- 32 to 87 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| blood biomarkersassessment of serum BNP, D-Dimer and CK-MB and CRP and globulin /albumin ratio stroke outcome | Other | cardioembolic stroke, non cardioembolic stroke |
Primary outcome
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
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 2019.
- Individual participant dataSharing planned: No
Related trials for Ischemic Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingPhase 3
Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis
Ischemic Stroke, TIA
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Wafaa Samir.
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 4 inclusion and 6 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 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
modified rankin scale (time frame: at the third week of stroke onset). 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 30 Apr 2019.