External Counterpulsation Therapy for Symptomatic and Severe Steno-occlusive Disease of Intracranial Internal Carotid or Middle Cerebral Artery and Impaired Cerebral Vasodilatory Reserve
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Improvement in cerebral vasodilatory reserve
研究概览
简要总结
Intracranial stenosis is prevalent among Asians and constitute a common cause of cerebral ischemia. While the best medical therapy carries stroke recurrence rates in access of 10% per year, intracranial stenting was associated with unacceptable peri-procedural ischemic events. Cerebral ischemic events are strongly related to the severity of intracranial stenosis, being high in patients with severe intracranial stenosis with poor vasodilatory reserve. Enhanced External Counter-Pulsation (EECP) therapy is known to improve myocardial perfusion by facilitating the development of collateral blood vessels in the heart. The investigators hypothesize that EECP therapy may be useful in patients with severe stenosis of intracranial internal carotid (ICA) or middle cerebral artery (MCA).
详细描述
Among Asian patients, intracranial stenosis is more common and accounts for about 30-50% of all strokes. The risk of recurrent stroke or TIA in presence of intracranial stenosis of a major intracranial artery and recent TIA/ stroke is about 23% at 1 year despite treatment. Recurrence rate for stroke/TIA in intracranial atherosclerosis is dependent on degree of stenosis as well as presence of collaterals. In WASID study, patients with more than 70% stenosis had greater risk of recurrent event then those with 50-69%. Interestingly, patients with more than 70% intracranial stenosis with good collaterals demonstrated a lower risk for subsequent cerebral ischemic events.
The two main mechanisms of ischemic stroke (IS) in these patients are thromboembolism and cerebral hemodynamic insufficiency. While Transcranial Doppler (TCD) monitoring can establish thrombo-embolic phenomenon and help in planning the appropriate antithrombotic treatment, assessment of dynamic cerebral hemodynamic insufficiency remains a complex issue, and may serve as a potential target for improving the outcomes (and reducing recurrent cerebral ischemia) in patients with severe intracranial stenoses.
Treatment options for Intracranial stenosis:
Anti-platelet agents are recommended for secondary prevention of IS. WASID trial compared warfarin with INR of 2-3 against aspirin, did not show any difference in outcome of stroke recurrence. Furthermore, aspirin was found to be safer as compared to warfarin.
Use of short-term double antiplatelet therapy is shown to be effective in reducing stroke/TIA recurrence risk. In CLAIR study, patients with recent symptoms (</=7 days) and with intracranial stenosis were randomized to clopidogrel and aspirin versus aspirin monotherapy. Combination anti-platelet therapy reduced micro-embolic signals on TCD on Day 2 and 7. Use of double antiplatelet in intracranial stenosis was also supported by findings of SAMMPRIS trial in which patient with recent stroke of TIA with 70-99% intracranial stenosis were randomized to angioplasty or maximal medical treatment. The 90 day recurrence risk of 5.8% in the medical arm was much lower than 10.7% recurrence rate observed in WASID trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome will be assessed by independent assessors for stroke/TIA recurrence within 6 months as well as change in cerebral vasodilatory reserve on acetazolamide challenged HMPAO- SPECT of brain.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with recent stroke/TIA and severe stenosis of intracranial ICA or MCA and impaired CVR within previous three months but not before 3 weeks after acute stroke. This is to differentiate between patients with a long-standing fixed-stenosis from patients with partially recanalized intracranial artery (masquerading as severe stenosis).
- •Age >21 years
排除标准
- •Patients with atrial fibrillation/ arrhythmias.
- •Within 2 weeks of cardiac catheterization or arterial puncture at femoral puncture site.
- •Decompensated heart failure , usually class 3 or 4
- •LV EF <30%
- •Moderate or severe AR
- •Persistent and uncontrolled hypertension (BP persistently >160/100 mmHg)
- •Bleeding diathesis
- •Active thrombophlebitis/ venous disease of lower limbs
- •Severe lower extremity vaso-occlusive disease
- •Presence of a documented aortic aneurysm/ dissection requiring surgical repair
结局指标
主要结局
Improvement in cerebral vasodilatory reserve
时间窗: at baseline and after 2 months of the completion of EECP therapy
To evaluate whether Enhanced External Counter-Pulsation (EECP) therapy would lead to a change in cerebral vasodilatory reserve (CVR) by at least 4% in patients with severe and recently symptomatic stenosis of intracranial carotid (ICA) or middle cerebral artery (MCA).
次要结局
- Stroke TIA/recurrence(at 6 months)
- Impact of EECP on cognition(at 6 months)
研究者
VIJAY KUMAR SHARMA
Associate Professor
National University of Singapore