Stroke, IschemicNCT06453252
Predictors of Intracranial Atherosclerotic Disease in Posterior Circulation: a Cohort Study
An observational study of Stroke, Ischemic and Intracranial Atherosclerosis, run by Sohag University at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Intracranial Atherosclerosis, Posterior Circulation Brain Infarction
- What is being tested?
- we are aiming to develop a Scoring system based on certain variables derived from both groups
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Aug 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult ≥18 years
- Patient with posterior circulation strokes who underwent mechanical thrombectomy.
Who cannot join
- Patients with anterior circulation stroke.
- Patients with intracranial hemorrhage
- Patients without baseline radiological data.
- Extracranial large vessel atherosclerosis related strokes.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Marcus stroke and neuroscience center, Grady Memorial Hospital
Atlanta, Georgia, 30303
Diogo C Haussen, MD, 786-280-2098, diogo.haussen@emory.edu
Mohamed A Tarek, MD,MSc
Egypt1 site
Sohag university hospitals
Sohag, 82524
Mohamed A Tarek, MD, MSc, +201011400632, m.a.tarek91@gmail.com
Mohamed A Tarek, MD,MSc
About this 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).
- Being tested
- we are aiming to develop a Scoring system based on certain variables derived from both groups
- Medical subject headings
- Ischemic Stroke, Intracranial Arteriosclerosis, Brain Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
we are aiming to develop a Scoring system based on certain variables derived from both groupsOther
We are aiming to develop a Scoring system based on certain variables derived from both group
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: we are aiming to develop a Scoring system based on certain variables derived from both groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: June 1st, 2025
Secondary outcomes (2)
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)
Measured: June 1st, 2025
90 day mortality
Measured: June 1st, 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University
- Responsible party
- Principal investigator, Mohamed Ahmed Tarek,MD,MSc, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453252
- Sponsor's protocol ID
- Soh-Med-24-05-04MD
- Status last verified
- Jul 2024
- First submitted
- 5 Jun 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Intracranial Atherosclerotic Disease in Posterior Circulation: a Cohort Study
- ClinicalTrials.gov ID
- NCT06453252
- Acronym / sponsor ID
- Soh-Med-24-05-04MD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Collaborators
- Emory University
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICAD group | – | Other: we are aiming to develop a Scoring system based on certain variables derived from both groupsincludes 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). |
| Non-ICAD cases (controls) | – | Other: we are aiming to develop a Scoring system based on certain variables derived from both groupsNon-ICAD cases (controls) includes patients with posterior circulation stroke attributed to stroke etiologies other than ICAD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adult ≥18 years
- Patient with posterior circulation strokes who underwent mechanical thrombectomy.
Key exclusion criteria (4 listed)
- Patients with anterior circulation stroke.
- Patients with intracranial hemorrhage
- Patients without baseline radiological data.
- Extracranial large vessel atherosclerosis related strokes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| we are aiming to develop a Scoring system based on certain variables derived from both groupsWe are aiming to develop a Scoring system based on certain variables derived from both group | Other | ICAD group, Non-ICAD cases (controls) |
Primary outcome
Post-procedural outcomes included any intracranial hemorrhage, symptomatic ICH (sICH)
Time frame: June 1st, 2025
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
2 secondary outcomes
90 day modified Rankin scale (mRS)
Time frame: June 1st, 2025
90 day mortality
Time frame: June 1st, 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke, Ischemic
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus stroke and neuroscience center, Grady Memorial Hospital
Atlanta, United States
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic and Intracranial Atherosclerosis, run by Sohag University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-procedural outcomes included any intracranial hemorrhage, symptomatic ICH (sICH) (time frame: June 1st, 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.