Enhanced Versus Standard Blood Pressure Lowering on Intracranial Aneurysm Rupture or Growth
概览
- 阶段
- 不适用
- 干预措施
- blood pressure lowering
- 疾病 / 适应症
- Unruptured Intracranial Aneurysm
- 发起方
- Beijing Tiantan Hospital
- 入组人数
- 570
- 试验地点
- 1
- 主要终点
- UIA instability
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
The goal of this randomized controlled trial is to evaluate the benefits and safety of controlled hypotension in Chinese patients with unruptured intracranial aneurysms(UIA).
The main questions it aims to answer are:
- To provide high-level evidence of the benefits and safety of controlled hypotension in patients with UIA.
- To provide evidence-based medical evidence for blood pressure control of patients with UIA in neurosurgery, and promote the progress of accurate individual management of patients. In this study, the main intervention is enhanced blood pressure lowering in patients with UIA.
All Patients will be randomly assigned to either the standard blood pressure lowering (SBPL) group or the enhanced blood pressure lowering (EBPL) group.
研究者
Wang Shuo
Director of Department of Cerebrovascular Neurosurgery
Beijing Tiantan Hospital
入排标准
入选标准
- •Chinese ethnicity.
- •Unruptured saccular intracranial aneurysm (UIA) identified by computational tomography angiography, magnetic resonance angiography or digital subtraction angiography.
- •Maximal size of UIA at largest dimension \< 7 mm
- •The morphology of UIA is regular (no bleb(s) or secondary aneurysm(s) protruding from the UIA fundus or bi-/ multi-lobular UIA fundus)
- •UIA receiving conservative treatment
- •History of primary hypertension (as diagnosed per standard of care)
- •Systolic blood pressure (SBP) on 2 consecutive visits:
- •SBP: 130-180 mmHg on 0 or 1 antihypertensive medication. SBP: 130-170 mmHg on up to 2 antihypertensive medications. SBP: 130-160 mmHg on up to 3 antihypertensive medications. SBP: 130-150 mmHg on up to 4 antihypertensive medications
- •Good medication adherence (Morisky Medication Adherence Scale ≥6)
- •Obtain informed consent from patient or legal representative
排除标准
- •Patients with neurological symptom related to UIA, such as sentinel headache, oculomotor paralysis and so on.
- •Patients with additional active intracranial disease including vasculopathy, arteriovenous malformation/fistula, cancer, traumatic brain injury etc.
- •Patients with fusiform, dissecting, blister, traumatic, mycotic/ bacterial, myxomatous, and tumor-associated UIAs are excluded.
- •Patients with history of polycystic kidney disease, rheumatic disease or autoimmune disease.
- •Patients with family history of intracranial aneurysm (defined when two direct relatives of patients within three generations have intracranial aneurysms or aneurysmal subarachnoid hemorrhage).
- •Patients with known secondary cause of hypertension.
- •Patients with myocardial infarction, ischemic stroke, symptomatic heart failure during the past 3 months.
- •Patients with a medical condition likely to limit survival to less than 2 years.
- •Patients during pregnancy and perinatal period.
- •Any concurrent serious illness that would interfere with the outcome assessments including hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease.
研究组 & 干预措施
standard blood pressure lowering (SBPL) group
干预措施: blood pressure lowering
enhanced blood pressure lowering (EBPL) group
干预措施: blood pressure lowering
结局指标
主要结局
UIA instability
时间窗: 24 months
The primary outcome is UIA instability (rupture, growth on radiological examination, or occurrence of aneurysm-related symptoms \[sentinel headache and oculomotor paralysis\]).
safety endpoint
时间窗: 24 months
The safety endpoint is any ischemic cerebral or cardiac events. This includes one or more of the following: new or more frequent transient ischemic attack, new clinical or radiological ischemic stroke, angina, new myocardial infarction, or reperfusion therapy for myocardial infarction.
次要结局
- UIA rupture events(In 24 months)
- UIA growth events(In 24 months)
- Change in average Wall Enhancement Index(At baseline and 24th month)