Perfusion by Arterial Spin labelling following Single dose Tadalafil In Small vessel disease (PASTIS): study protocol for a randomised controlled trial
Perfusion by Arterial Spin labelling following Single dose Tadalafil In Small vessel disease (PASTIS): study protocol for a randomised controlled trial
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DOI：
10.1186/s13063-017-1973-9
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发表时间：
2017-05-22
期刊：
影响因子：
2.5
通讯作者：
Hainsworth, Atticus H.
中科院分区：
文献类型：
--
作者：
Pauls, Mathilde M. H.;Clarke, Natasha;Hainsworth, Atticus H.
背景：脑部小血管疾病是老年人血管认知功能障碍的常见原因，没有获得许可的治疗方法。小血管疾病患者的脑血流量减少。他达拉非是一种被广泛处方的磷酸二酯酶-5抑制剂，可以增加其他血管区域的血流量。这项试验的目的是验证他达拉非增加患有小血管疾病的老年人的脑血流量的假设。方法/设计：单剂量他达拉非治疗小血管疾病(PASTIS)后动脉自旋标记灌流是一项II期随机双盲交叉试验。在相隔7-30天的两次访问中，参与者接受动脉旋转标记以测量脑血流，并进行一系列认知测试，在服用他达拉非(20毫克)或安慰剂前后进行。样本大小：54名参与者被要求检测皮质下白质中15%的脑血流量增加(P<；0.05，90%功率)。主要结果是皮质下白质和深灰色核团的脑血流。次要结果是大脑皮质灰质脑血流量和认知测试成绩(反应时、信息处理速度、前后数字广度、语义流利性)。讨论：招募于2015年9月4日开始，截至2017年4月19日，已完成36名参与者。没有发生严重的不良事件。所有参与者都是从圣乔治大学医院NHS基金会信托基金招募的。
Background: Cerebral small vessel disease is a common cause of vascular cognitive impairment in older people, with no licensed treatment. Cerebral blood flow is reduced in small vessel disease. Tadalafil is a widely prescribed phosphodiesterase-5 inhibitor that increases blood flow in other vascular territories. The aim of this trial is to test the hypothesis that tadalafil increases cerebral blood flow in older people with small vessel disease.Methods/design: Perfusion by Arterial Spin labelling following Single dose Tadalafil In Small vessel disease (PASTIS) is a phase II randomised double-blind crossover trial. In two visits, 7-30 days apart, participants undergo arterial spin labelling to measure cerebral blood flow and a battery of cognitive tests, pre- and post-dosing with oral tadalafil (20 mg) or placebo. Sample size: 54 participants are required to detect a 15% increase in cerebral blood flow in subcortical white matter (p < 0.05, 90% power). Primary outcomes are cerebral blood flow in subcortical white matter and deep grey nuclei. Secondary outcomes are cortical grey matter cerebral blood flow and performance on cognitive tests (reaction time, information processing speed, digit span forwards and backwards, semantic fluency).Discussion: Recruitment started on 4th September 2015 and 36 participants have completed to date (19th April 2017). No serious adverse events have occurred. All participants have been recruited from one centre, St George's University Hospitals NHS Foundation Trust.