Predictors of Intracranial Atherosclerotic Disease in Posterior Circulation: a Cohort Study

NCT06453252 | Not Yet Recruiting FDA Drug

• 1 other identifier: Soh-Med-24-05-04MD
• Study Type: observational
• Target: 150
• Locations: 2 countries
• Sites: 2

Brief Summary

Early identification of intracranial atherosclerotic disease (ICAD) may impact the management of patients undergoing mechanical thrombectomy (MT). The aim of the study is to develop and validate a scoring system for pre-thrombectomy diagnosis of ICAD in posterior circulation large vessel/distal medium vessel occlusion strokes (LVOs/DMVOs).

Conditions

Stroke, Ischemic; Intracranial Atherosclerosis; Posterior Circulation Brain Infarction

Outcome Measures

Primary Outcomes (1)

• Post-procedural outcomes included any intracranial hemorrhage, symptomatic ICH (sICH)

  sICH is defined as local or remote parenchymal hemorrhage type 2, subarachnoid hemorrhage, and/or intraventricular hemorrhage, combined with a neurological deterioration of 4 points or more on the NIHSS from baseline or leading to death that the physician judged was causative of the deterioration) per ECASS III criteria

  June 1st, 2025

Secondary Outcomes (2)

• 90 day modified Rankin scale (mRS)

  June 1st, 2025

• 90 day mortality

  June 1st, 2025

Study Arms (2)

ICAD group

includes ICAD-related stroke made when a smooth-bordered lesions leading to delayed perfusion on conventional-angiography (without competing stroke etiology) or when irregular-surfaced lesions involving the target vessel during mechanical thrombectomy were unveiled (with or without competing stroke etiology).

Other: we are aiming to develop a Scoring system based on certain variables derived from both groups

Non-ICAD cases (controls)

Non-ICAD cases (controls) includes patients with posterior circulation stroke attributed to stroke etiologies other than ICAD.

Other: we are aiming to develop a Scoring system based on certain variables derived from both groups

Interventions

we are aiming to develop a Scoring system based on certain variables derived from both groups OTHER

We are aiming to develop a Scoring system based on certain variables derived from both group

ICAD group; Non-ICAD cases (controls)

Eligibility Criteria

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

Study Population

The cohort is divided into 2 groups; 1. ICAD-related stroke made when a smooth-bordered lesions leading to delayed perfusion on conventional-angiography (without competing stroke etiology) or when irregular-surfaced lesions involving the target vessel during mechanical thrombectomy were unveiled (with or without competing stroke etiology). 2. Non-ICAD cases (controls) includes patients with posterior circulation stroke attributed to stroke etiologies other than ICAD.

You may qualify if:

• Adult ≥18 years
• Patient with posterior circulation strokes who underwent mechanical thrombectomy.

You may not qualify if:

• Patients with anterior circulation stroke.
• Patients with intracranial hemorrhage
• Patients without baseline radiological data.
• Extracranial large vessel atherosclerosis related strokes.

Sponsors & Collaborators

• Sohag University: lead
• Emory University: collaborator

Study Sites (2)

Marcus stroke and neuroscience center, Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Sohag university hospitals

Sohag, 82524, Egypt

Location

MeSH Terms

Conditions

Ischemic Stroke; Intracranial Arteriosclerosis; Brain Infarction

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Neurology

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: August 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

EG (1); US (1)