Predictive Factors of Outcome of Mechanical Thrombectomy After Acute Ischemic Stroke

August 1, 2018 updated by: Ahmed Abdelhady Hamed Mohamed, Assiut University
Predictive factors of outcome of mechanical thrombectomy after acute ischemic stroke

Study Overview

Status

Unknown

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:-

  1. Time of presentation.
  2. Age.
  3. Clinical presentation.
  4. Risk factors include Hyperglycemia, peripheral vessel disease, atrial fibrillation, coronary heart disease, hyperlipidemia, smoking, and history of pervious stroke,
  5. Socioeconomic status.
  6. 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

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with acute ischemic stroke

Description

Inclusion Criteria:

  1. Age >18 years
  2. 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
  3. With or without intravenous thrombolysis
  4. Access to endovascular treatment within 24 hours from onset.
  5. In selected patients with acute ischemic stroke within 6 to 24 hours of onset must meet DAWN or DEFUSE 3 eligibility criteria.

Exclusion Criteria:

  1. Proven occlusion of the cervical carotid artery
  2. Disability prior to the stroke (modified ranking scale >3)
  3. Opposition of the patient or their family

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 30, 2018

Primary Completion (Anticipated)

February 28, 2019

Study Completion (Anticipated)

February 28, 2020

Study Registration Dates

First Submitted

July 9, 2018

First Submitted That Met QC Criteria

July 31, 2018

First Posted (Actual)

August 1, 2018

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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