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出境医 / 临床实验 / Cardio-embolic Stroke and Blood Bio-markers

Cardio-embolic Stroke and Blood Bio-markers

Study Description
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.

Condition or disease Intervention/treatment
Ischemic Stroke Other: blood biomarkers

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
Layout table for study information
Study Type : Observational
Actual Enrollment : 96 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Cardio-embolic Stroke and Blood Bio-markers:Diagnosis and Predictors of Short Term Outcome.
Actual Study Start Date : October 2015
Actual Primary Completion Date : October 2018
Actual Study Completion Date : December 2018
Arms and Interventions
Group/Cohort Intervention/treatment
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

Outcome Measures
Primary Outcome Measures :
  1. 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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   32 Years to 87 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date April 23, 2019
First Posted Date April 25, 2019
Last Update Posted Date April 30, 2019
Actual Study Start Date October 2015
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2019)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cardio-embolic Stroke and Blood Bio-markers
Official Title Cardio-embolic Stroke and Blood Bio-markers:Diagnosis and Predictors of Short Term Outcome.
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.
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 Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Ischemic Stroke
Intervention Other: blood biomarkers
assessment of serum BNP, D-Dimer and CK-MB and CRP and globulin /albumin ratio stroke outcome
Study Groups/Cohorts
  • cardioembolic stroke
    Intervention: Other: blood biomarkers
  • non cardioembolic stroke
    Intervention: Other: blood biomarkers
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 23, 2019)
96
Original Actual Enrollment Same as current
Actual Study Completion Date December 2018
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 32 Years to 87 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03927872
Other Study ID Numbers ZU-IRB# :2325/7-9-2015).
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Wafaa Samir, Zagazig University
Study Sponsor Wafaa Samir
Collaborators Not Provided
Investigators Not Provided
PRS Account Zagazig University
Verification Date April 2019