The Capillary Index Score Trial

Firas Al-Ali

Status and phase: Completed; Phase 1

Conditions: Brain Ischemia; Ischemic Stroke; Acute Stroke

Treatments: Procedure: Endovascular Treatment (EVT)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02618031

CIS Trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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57 participants in 2 patient groups

Favorable CIS

Other group

Description:

Patients with a favorable CIS (fCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines.

Treatment:

Procedure: Endovascular Treatment (EVT)

Poor CIS

Experimental group

Description:

Patients with a poor CIS (pCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines.

Treatment:

Procedure: Endovascular Treatment (EVT)