The Prevalence and Associated Factors of Early Deterioration After Successful Recanalization in Acute Ischemic Stroke

July 16, 2021 updated by: Osama Ibrahim Aboelfath Ibrahim, Assiut University

The Prevalence and Associated Factors of Early Neurological Deterioration After Successful Recanalization Treatment in Patients With Acute Ischemic Stroke

stroke is a leading cause of morbidity and mortality worldwide. More than half (54.5%) of the 56.9 million deaths worldwide in 2106 were due to the top 10 causes.

Ischemic heart disease and stroke are the world's biggest killers, accounting for a combined 15.2 million deaths in 2106. These diseases have remained the leading causes of death globally in the last 15 years.

Recent clinical trials have shown that endo-vascular thrombectomy is an effective and safe recanalization modality for acute ischemic stroke patients .

Meta-analysis results show that endovascular treatment is associated with a high ratio of successful recanalization rate and a low rate of symptomatic hemorrhage .

Approximately 2.2-37.5% of patients with acute ischemic stroke might encounter early neurological deterioration (END).

Definition of END: An increase in NIHSS ≥4 or an increase in Ia of NIHSS ≥1 within 72 h after recanalization treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients admittedto Assiut University Hospitals within time window for thrombolysis or thrombectomy within one year are included

Description

Inclusion Criteria:

  1. Ischemic stroke of both sex.
  2. More than 08 years.
  3. Accepting all study requirements.
  4. within time window for thrombolysis or thrombectomy
  5. fulfilling criteria for thrombolysis or thrombectomy

Exclusion Criteria:

(A)Absolute Contraindications :

  1. Intracerebral hemorrhage history or presence on imaging
  2. Time of onset more than 465 hours
  3. Blood pressure greater than 085/000 mm Hg
  4. Recent severe head trauma or neurosurgical intervention
  5. Coagulopathy (INR >067, thrombocytopenia, recent use of heparin or direct oral anticoagulants)
  6. Endocarditis (infective)
  7. Aortic dissection (B)Potential Contraindications :

1.Seizure at onset 2.Noncompressible arterial puncture 3.Recent surgery 4.Gastrointestinal or genitourinary bleeding 5.Multiple cortical microbleeds (>00) 6. Large intracranial aneurysms or arteriovenous malformations 7.Recent transmural myocardial infarction 8. Small NIHSS with nondisabling stroke symptoms

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
Prevalence of early neurological deterioration after successful recanalization treatment in patients with acute ischemic stroke
Time Frame: 1 year
Prevalence of early neurological deterioration after successful recanalization treatment in patients with acute ischemic stroke
1 year
factors of deterioration
Time Frame: 1 year
factors of deterioration
1 year

Collaborators and Investigators

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

Sponsor

Assiut University

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)

August 1, 2021

Primary Completion (Anticipated)

July 30, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

July 16, 2021

First Submitted That Met QC Criteria

July 16, 2021

First Posted (Actual)

July 27, 2021

Study Record Updates

Last Update Posted (Actual)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 16, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • recanalization deterioration

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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