The Capillary Index Score Trial: Phase I
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 11
- 主要终点
- Modified Rankin Score (mRS) Between Favorable CIS Group Versus Poor CIS Group.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The participants and investigators evaluating 90 day outcomes will be blinded to the group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Modified Rankin Score (mRS) Between Favorable CIS Group Versus Poor CIS Group.
时间窗: 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).
次要结局
- 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)
研究者
Firas Al-Ali
Neurointerventionalist
Cleveland Clinic Akron General