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

Acute Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04978181
• Other study ID #: recanalization deterioration
• Status: Not yet recruiting
• Start date: August 1, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: July 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 1, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

Drug:
• Alteplase Injection
thrombolytic therapy for acute ischemic stroke in time window

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	factors of deterioration	factors of deterioration	1 year