- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03608644
Predictive Factors of Outcome of Mechanical Thrombectomy After Acute Ischemic Stroke
Study Overview
Status
Conditions
Detailed Description
Acute ischemic stroke is one of the most common causes of disability, dementia and death in developing world. In Egypt, the total lifetime prevalence of ischemic stroke was 7.2/1,000 in the population aged 20 years and more . Although the intravenous thrombolysis is a treatment option within ≤ 4.5 hours after stroke onset, the mechanical thrombectomy can be performed within a more extended time window. A positive results of 5 recent randomized clinical trials are driven mainly from patients treated by mechanical thrombectomy within 6 hours from onset and they demonstrated a clear benefit for mechanical thrombectomy in combination with intravenous thrombolysis. More recent two randomized clinical trials DAWN and DEFUSE 3 demonstrated an overall benefit in functional outcome at 90 days in patients treated with mechanical thrombectomy within 6 to 24 hours or 6 to 16 hours form onset respectively with special criteria. A major issue remains as to identifying patients which likely to benefit from mechanical thrombectomy to improve selection and subsequently clinical prognosis .
These factors include:-
- Time of presentation.
- Age.
- Clinical presentation.
- Risk factors include Hyperglycemia, peripheral vessel disease, atrial fibrillation, coronary heart disease, hyperlipidemia, smoking, and history of pervious stroke,
- Socioeconomic status.
- Collateral and stroke core. In this study the investigators will evaluate prognostic factors influencing angiographic and clinical outcomes at discharge and at three months after mechanical thrombectomy of acute ischemic stroke within 24 hours.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: wafaa mohamed farghaly, professor
- Phone Number: 01004489683
- Email: wafmaf2002@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age >18 years
- Cerebral infarction in the anterior or posterior circulation (intracranial internal carotid artery, M1 or M2 middle cerebral artery, basilar or vertebral arteries) proven by Computed tomography angiography
- With or without intravenous thrombolysis
- Access to endovascular treatment within 24 hours from onset.
- In selected patients with acute ischemic stroke within 6 to 24 hours of onset must meet DAWN or DEFUSE 3 eligibility criteria.
Exclusion Criteria:
- Proven occlusion of the cervical carotid artery
- Disability prior to the stroke (modified ranking scale >3)
- Opposition of the patient or their family
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The outcomes of mechanical thrombectomy after acute ischemic stroke within three months
Time Frame: 3 months
|
Modified Rankin Scale (mRS) for measuring the degree of disability
|
3 months
|
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
- PFOOOMTAAIS
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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