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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke, Ischemic; Intracranial Atherosclerosis; Posterior Circulation Brain Infarction
• Intervention / Treatment: Other: we are aiming to develop a Scoring system based on certain variables derived from both groups

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 82524
    • Sohag University hospitals
    • Contact: Mohamed A Tarek, MD, MSc; Phone Number: +201011400632; Email: m.a.tarek91@gmail.com
    • Principal Investigator: Mohamed A Tarek, MD,MSc
    • Sub-Investigator: Mohamed Abdelmoneim Sayed, MD,MSc,PhD
    • Sub-Investigator: Hazem Kamal Ibrahim, MD,MSc,PhD
    • Sub-Investigator: Ahmed Borai Ahmed Mahran, MD,MSc,PhD
• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Marcus stroke and neuroscience center, Grady Memorial Hospital
      • Contact: Diogo C Haussen, MD; Phone Number: 786-280-2098; Email: diogo.haussen@emory.edu
      • Sub-Investigator: Mohamed A Tarek, MD,MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with anterior circulation stroke.
2. Patients with intracranial hemorrhage
3. Patients without baseline radiological data.
4. Extracranial large vessel atherosclerosis related strokes.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; We are aiming to develop a Scoring system based on certain variables derived from both group
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; We are aiming to develop a Scoring system based on certain variables derived from both group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
90 day mortality		June 1st, 2025
90 day modified Rankin scale (mRS)	a score of 0 to 4 on the modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 4 moderately severe disability, and 6 death) at 90 days, was changed to a good functional status (a modified Rankin scale score of 0 to 3, with a score of 3 indicating moderate disability)	June 1st, 2025

Collaborators and Investigators

• Sponsor: Sohag University
• Collaborators: Emory University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: June 5, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Brain Ischemia; Stroke; Intracranial Arterial Diseases; Infarction; Ischemic Stroke; Atherosclerosis; Brain Infarction; Intracranial Arteriosclerosis
• Other Study ID Numbers: Soh-Med-24-05-04MD

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