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

NCT04978181 | Unknown DMC FDA Drug

• 1 other identifier: recanalization deterioration
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Stroke

Outcome Measures

Primary Outcomes (2)

• Prevalence of early neurological deterioration after successful recanalization treatment in patients with acute ischemic stroke

  Prevalence of early neurological deterioration after successful recanalization treatment in patients with acute ischemic stroke

  1 year

• factors of deterioration

  factors of deterioration

  1 year

Interventions

Alteplase Injection DRUG

thrombolytic therapy for acute ischemic stroke in time window

Also known as: thrombolysis

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Ischemic stroke of both sex.
• More than 08 years.
• Accepting all study requirements.
• within time window for thrombolysis or thrombectomy
• fulfilling criteria for thrombolysis or thrombectomy

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Stroke

Interventions

Tissue Plasminogen Activator; Fibrinolytic Agents

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Cardiovascular Agents; Therapeutic Uses; Hematologic Agents

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: osama ibrahim abo-elfath

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 27, 2021
• Study Start: August 1, 2021
• Primary Completion: July 30, 2022
• Study Completion: August 1, 2022
• Last Updated: July 27, 2021

Record last verified: 2021-07