- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03927872
Cardio-embolic Stroke and Blood Bio-markers
Cardio-embolic Stroke and Blood Bio-markers:Diagnosis and Predictors of Short Term Outcome.
Study Overview
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
cardioembolic stroke
|
assessment of serum BNP, D-Dimer and CK-MB and CRP and globulin /albumin ratio stroke outcome
|
non cardioembolic stroke
|
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZU-IRB# :2325/7-9-2015).
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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