Intracranial Collaterals in Acute Stroke and Clinical Outcome

NCT03311386 | Completed

• 1 other identifier: Collaterals and acute stroke
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Assessment of the evolution of intracranial collaterals and its relationship with functional outcomes in acute ischemic stroke (AIS) patients treated with IV tissue plasminogen activator (tPA).

Conditions

Collateral Circulation, Any Site

Outcome Measures

Primary Outcomes (1)

• 90-days functional outcome

  90-day modified Rankin Score (mRS) 0-2 or equal to the pre-stroke modified Rankin scale he Modified Rankin Scale (mRS) The scale runs from 0-6 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.

  90 days

Secondary Outcomes (1)

• Early neurologic improvement

  24 hours

Study Arms (1)

Patients in AIS receiving actilyse

the patients will receive actilyse intaravenously in a dose of 0.9mg/kg once

Drug: Actilyse

Interventions

Actilyse DRUG

thrombolytic therapy

Also known as: Alteplase

Patients in AIS receiving actilyse

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with acute ischemic stroke within 4.5 hours - legible for receiving IV r TPA- admitted to Neurology department of Asyut University within 1 year (2017-2018)

You may qualify if:

• Patient presenting to the emergency department with symptoms consistent with ischemic stroke.
• Age \> 18 yrs.
• Evidence of a visible and symptomatic intracranial occlusion on baseline CT-angiography (intracranial ICA, M1 MCA segment +/- intracranial ICA, proximal M2 MCA).
• Treatment with IV tPA.

You may not qualify if:

• Intracranial hemorrhage (ICH) identified on baseline CT.
• Previous moderate to large stroke in the ipsilesional hemisphere.
• Modified Rankin Scale \> 2 at baseline.
• Unable to have CT-angio performed due to recent estimated creatinine clearance eCCr\<60 ml/min, contrast allergy or other reasons.
• Any terminal illness (patient not expected to survive \> 1 year).

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, 71511, Egypt

Location

Related Publications (1)

• Bang OY, Goyal M, Liebeskind DS. Collateral Circulation in Ischemic Stroke: Assessment Tools and Therapeutic Strategies. Stroke. 2015 Nov;46(11):3302-9. doi: 10.1161/STROKEAHA.115.010508. Epub 2015 Oct 8. No abstract available.

  PMID: 26451027 BACKGROUND

MeSH Terms

Interventions

Tissue Plasminogen Activator

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

Study Officials

• Essam Darwish, Professor

  Assiut University

  PRINCIPAL INVESTIGATOR

• Ahmed Hamdy, Ass.Prof

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 17, 2017
• Study Start: November 23, 2017
• Primary Completion: January 1, 2021
• Study Completion: August 1, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

EG (1)