The Capillary Index Score Trial: Phase I
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute Stroke
- Sponsor
- Firas Al-Ali
- Enrollment
- 57
- Locations
- 6
- Primary Endpoint
- Modified Rankin Score (mRS) Between Favorable CIS Group Versus Poor CIS Group.
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This study seeks to investigate the capillary index score (CIS) to further improve patient selection of endovascular treatment (EVT) in acute ischemic stroke (AIS).
The hypothesis or idea being tested:
Patients with favorable CIS who are successfully revascularized with EVT can have successful outcomes with an extended time window for treatment.
Detailed Description
This study is trying to look at how the well-being of the patient following treatment is influenced by peripheral blood supply (collateral flow) to the area lacking primary blood flow due to the clot. Treatment of AIS includes EVT and medical treatment. EVT is typically not offered to patients after 6 hours of the onset of symptoms. The current study is based on the belief that patients can be successfully treated with the EVT up to 8 hours, as long as they have good peripheral blood flow (collateral flow) to the area of tissue blocked of the primary blood supply. The study will evaluate the ability of the capillar index score (CIS) to identify patients who can be successfully treated with EVT. The CIS quantifies blood supply to the ischemic area from peripheral vessels (collateral flow) based on diagnostic cerebral angiogram. Patients are graded on a scale from 0-3, with 0 and 1 considered a poor CIS (pCIS) and 2 and 3 considered a favorable CIS (fCIS). All patients will be treated with EVT and medical treatment consistent with national guidelines. The primary endpoint is the clinical outcome at 90 days between fCIS group versus pCIS group. The secondary endpoint is the influence of successful revascularization on outcomes for patients with fCIS or pCIS.
Investigators
Firas Al-Ali
Neurointerventionalist
Cleveland Clinic Akron General
Eligibility Criteria
Inclusion Criteria
- •Anterior circulation acute ischemic stroke due to blockage of the intracranial internal carotid artery or middle cerebral artery (M1)
- •Within 24 hours of onset of symptoms
- •NIHSS Score is 8 or greater
Exclusion Criteria
- •Contra-indication for IAT found on initial CT
- •Intracranial hemorrhage
- •Stroke mimics (tumor, herpetic encephalitis, etc.)
- •More than 1/3 hypodensity on non-enhanced head CT prior to intervention
- •ASPECT Score less than 6
- •Pre-existing disability defined as modified Rankin Scale (mRS) score more than 2
- •Pregnant women
Outcomes
Primary Outcomes
Modified Rankin Score (mRS) Between Favorable CIS Group Versus Poor CIS Group.
Time Frame: 90 days
The mRS Score ranges from 0-6 and describes the degree of disability or dependence after a stroke. The grades are no symptoms (0), no significant disability (1), slight disability (2), moderate disability (3), moderately severe disability (4), severe disability (5), and death (6).
Secondary Outcomes
- Complication Rate Between Favorable CIS Group Versus Poor CIS Group(1 day - 1 week)
- Modified Rankin Score (mRS) Between Favorable CIS With Good Revascularization Versus Poor CIS With Good Revascularization.(90 days)