Penumbra and Recanalisation Acute Computed Tomography in Ischaemic Stroke Evaluation
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Proportion of patients receiving Intravenous Recombinant Tissue Plasminogen Activator (IV rtPA)
研究概览
简要总结
Stroke affects over 125,000 people each year in the UK and leaves at least 50% disabled. Treatment of stroke caused by a blockage in a blood vessel (ischaemic stroke), with clotbusting drugs improves the chances of good recovery, but must be given within 4.5 hours of onset. Currently only a small proportion of patients who arrive in hospital within 4.5 hours are treated. This is largely due to uncertainty about diagnosis and concerns about risk of bleeding associated with clotbusting medication. Patients with mild or improving symptoms in particular are often not treated because of uncertainty about relative risks and benefits. However, around one third of these patients go on to be significantly disabled. Routine CT scanning often does not show abnormalities in acute stroke (which take hours to become easily visible), and cannot show the extent or severity of blood flow changes in ischemic stroke.
We wish to investigate the value of additional CT scanning that gives information on the blood vessels (angiography, CTA) and blood flow to the brain (perfusion, CTP) by undertaking a randomised trial. Extra scans are done in the same scanner and involve some extra radiation, injections of a contrast dye, and some extra time to acquire process and interpret. The extra scans may allow better treatment decisions for patients by increasing diagnostic certainty and by better assessment of stroke severity. However, we do not know whether the potential gains from better selection justify the resources and potential treatment delays that are involved. We will investigate whether the proportion of patients given clotbusting drugs differs between the two scanning protocols; and whether the outcomes differ, using standard measures of disability. We will also investigate whether use of different scanner manufacturers' software affect interpretation of scans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Clinical diagnosis of stroke eligible for IV rtPA according to current guidelines
- •Informed consent
- •Male or nonpregnant female ≥18 years of age
- •Within 4.5 hours of onset as defined by time since last known well
排除标准
- •Contraindications to thrombolytic drug treatment for stroke
- •Pregnancy
- •Known impaired renal function precluding contrast CT
- •Known allergy to CT contrast agents
- •Severe concurrent medical condition that would prevent participation in study procedures (e.g. cardiac failure with severe pulmonary oedema) or with life expectancy ≤ 3 months.
研究组 & 干预措施
Control imaging (NCCT)
Standard imaging
干预措施: control imaging (Other)
additional multimodal imaging
CT + CTA + CTP
干预措施: additional multimodal imaging (Other)
结局指标
主要结局
Proportion of patients receiving Intravenous Recombinant Tissue Plasminogen Activator (IV rtPA)
时间窗: 4.5 hours from onset
Data will be collected at 4.5 hours from onset, comparison of proportion of patients receiving treatment will only be assessed at the end of the study
次要结局
- Time to treatment decision and administration(4.5 hours from onset)
- Comparisons of efficacy & safety outcomes in Target Population (imaged as per randomised allocation and per protocol)(90 days after onset)
- Interobserver agreement in interpretation of locally processed Computed Tomography Perfusion (CTP) scans(Six months after recruitment)
- 3 month modified Rankin Scale (mRS), by intention to treat, using a Cochran Mantel Haeszel distribution analysis(90 days from onset)
- Safety - symptomatic Intracerebral hemorrhage (ICH) and major infarct swelling rates(7 days from onset)
- Diagnostic sensitivity and specificity(4.5 hours from onset)
- 3 month mRS distribution in patients i) selected for IV rtPA and excluded from IV rtPA(90 days from onset)
- Interobserver Agreement for rtPA eligibility between local and centrally processed CTP/CTA(Six months after recruitment)
