- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03701412
Prevalence of Cerebral Micro-bleeds in Patients With Cerebrovascular Stroke
Study Overview
Detailed Description
Cerebral microbleed (CMB) refers to small, round dark-signal lesions detected by T2*-weighted or gradient-echo (GRE) magnetic resonance imaging (MRI). CMBs were introduced to stroke physicians in the late 1990s and early 2000s after development of MRI techniques sensitive to paramagnetic effects The clinical significance of CMBs has been actively investigated, especially in the stroke field and more recently in studies on cognitive impairment, vascular dementia and later developement of cerebral hge ..Histological investigation has shown that CMBs are tiny foci containing hemosiderin-laden macrophages and abnormal microvessels .
Clinical cases with frank symptoms caused by CMBs are uncommon, Because CMBs are manifestations of focal extravascular leakage of blood components, however, investigators have suggested that accumulation of CMBs reflects a bleeding-prone status in individuals with an elevated risk of cerebral hemorrhage. Clinical studies have found strong associations between CMBs and chronic hypertension and low cholesterol levels and between the proximity and volume of CMBs and those of subsequent intracerebral hemorrhage (ICH) . studies have found that CMBs are linked to subsequent hemorrhagic stroke in stroke survivors,and suggested that CMBs are related to antithrombotic-related hemorrhage.
Clinical implications of cerebral microbleeds The increased of cerebral hemorrhage associated with the presence of CMBs may allow prediction of hemorrhagic transformation after ischemic stroke. An earlier report suggested that hemorrhagic transformation after thrombolysis was associated with the presence of CMBs.
Considerable interest also exists in utilizing detection of CMBs to estimate the risks of hemorrhagic complications in patients on antithrombotic treatment. , CMBs were found to be more frequent and extensive in patients with double antiplatelets-associated ICH.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients diagnosed as ischemic CVS or Transient ischemic attack admitted to Assuit University Hospital or visiting outpatient clinic.
- Old stroke patients on double antiplatelet therapy for duration more than 3 months
- old stroke patients on anticoagulants.
Exclusion Criteria:
- Patients with blood diseases hepatic and renal patient. Patients with cerebral hemorrhage.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
analyse Risk factors responsible for development of cerebral micro bleeds.
Time Frame: 1 year
|
All patients will undergo T2*-weighted or gradient-echo (GRE) magnetic resonance imaging (MRI) for detection of micro bleeds
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- POCMIPWCVS
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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