Clinical trial NCT02618031: The Capillary Index Score Trial
Official title: The Capillary Index Score Trial: Phase I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Stroke
Brain Ischemia
Ischemic Stroke
Keywords: capillary index score
acute ischemic stroke
collateral circulation
cerebral ischemia
diagnostic imaging
Lead sponsor: Cleveland Clinic Akron General
Sponsor class: OTHER
Collaborators: name: Stryker Neurovascular
name: Rochester General Hospital
name: University of Vermont Medical Center
name: University of North Carolina, Chapel Hill
name: NYU Langone Health
name: WellStar Health System
First posted: 2015-12-01
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be assigned to one of two groups based on the outcome of diagnostic evaluation. Treatment will be identical for the two groups.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

1. Anterior circulation acute ischemic stroke due to blockage of the intracranial internal carotid artery or middle cerebral artery (M1)
2. Within 24 hours of onset of symptoms
3. NIHSS Score is 8 or greater

Exclusion Criteria:

1. Contra-indication for IAT found on initial CT
2. Intracranial hemorrhage
3. Stroke mimics (tumor, herpetic encephalitis, etc.)
4. More than 1/3 hypodensity on non-enhanced head CT prior to intervention
5. ASPECT Score less than 6
6. Pre-existing disability defined as modified Rankin Scale (mRS) score more than 2
7. Pregnant women

Primary outcomes:
measure: Modified Rankin Score (mRS) Between Favorable CIS Group Versus Poor CIS Group.
timeFrame: 90 days
Secondary outcomes:
measure: Complication Rate Between Favorable CIS Group Versus Poor CIS Group
timeFrame: 1 day - 1 week
measure: Modified Rankin Score (mRS) Between Favorable CIS With Good Revascularization Versus Poor CIS With Good Revascularization.
timeFrame: 90 days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: WellStar Atlanta Medical System
state: Georgia
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospital
state: North Carolina
city: Akron
country: United States
facility: Akron General Medical Center
state: Ohio
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
affiliation: Cleveland Clinic Akron General
name: Firas Al-Ali, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al-Ali F, Elias JJ, Filipkowski DE, Faber JE. Acute ischemic stroke treatment, part 1: patient selection "the 50% barrier and the capillary index score". Front Neurol. 2015 Apr 22;6:83. doi: 10.3389/fneur.2015.00083. eCollection 2015.
citation: Al-Ali F, Elias JJ, Filipkowski DE. Acute Ischemic Stroke Treatment, Part 2: Treatment "Roles of Capillary Index Score, Revascularization and Time". Front Neurol. 2015 Jun 1;6:117. doi: 10.3389/fneur.2015.00117. eCollection 2015.
citation: Al-Ali F, Elias JJ, Tomsick TA, Liebeskind DS, Broderick JP; IMS Study Groups. Relative Influence of Capillary Index Score, Revascularization, and Time on Stroke Outcomes From the Interventional Management of Stroke III Trial. Stroke. 2015 Jun;46(6):1590-4. doi: 10.1161/STROKEAHA.115.009066. Epub 2015 May 7.
citation: Al-Ali F, Tomsick TA, Connors JJ 3rd, Gebel JM, Elias JJ, Markarian GZ, Al-Ali Z, Broderick JP. Capillary Index Score in the Interventional Management of Stroke trials I and II. Stroke. 2014 Jul;45(7):1999-2003. doi: 10.1161/STROKEAHA.114.005304. Epub 2014 May 22.
citation: Al-Ali F, Jefferson A, Barrow T, Cree T, Louis S, Luke K, Major K, Nemeth D, Smoker S, Walker S. The capillary index score: rethinking the acute ischemic stroke treatment algorithm. Results from the Borgess Medical Center Acute Ischemic Stroke Registry. J Neurointerv Surg. 2013 Mar;5(2):139-43. doi: 10.1136/neurintsurg-2011-010146. Epub 2012 Jan 19.