The Effect of Cerebrolysin on the Blood-brain-barrier in Patients With Diabetes and Ischemic Stroke
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Blood-Brain-Barrier Permeability after 10-14days of cerebrolysin in patients with AIS of the middle cerebral artery
研究概览
简要总结
A prospective, single-center study would be carried out in the Neurology Department of the University Hospital "Dr. José Eleuterio González" in order to analyze the effect of cerebrolysin on the blood-brain-barrier in patients with ischemic stroke with personal history of type-2 diabetes
详细描述
A prospective, single-center study would be carried out in the Neurology Department of the University Hospital "Dr. José Eleuterio González" in order to analyze the effect of cerebrolysin on the blood-brain-barrier (BBB) in patients with ischemic stroke (IS) of the middle cerebral artery with personal history of type-2 diabetes (T2D).
The main objective is to compare the effect of cerebrolysin on the BBB in the above mentioned patients with intravenous thrombolysis (IVT) and without IVT.
The hypothesis of this study is that cerebrolysin can affect the BBB permeability after 10 days of the administration of this drug
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 80 years.
- •Clinical and imaging criteria for ischemic stroke of the middle cerebral artery.
- •Acute non-lacunar cerebral infarction.
- •Cerebral infarction with a score on the NIH scale between 5 and 20 points.
- •Patient with a previous diagnosis of type 2 diabetes mellitus, regardless of the form of diagnosis, time of evolution, previous or current treatment, adherence or not to treatment, presence or absence of microvascular and/or macrovascular complications.
- •mRs ≤ 1 before the qualifying stroke (functionally independent for all activities of daily living).
- •The patient and/or legal representative or direct family member has signed the informed consent form.
排除标准
- •Advanced disease or terminal with life expectancy < 6 months.
- •Over 80 years old
- •Lacunar infarction or small vessel disease.
- •Pre-existing medical, neurological, or psychiatric disease that would confound neurological or functional evaluations (eg, Alzheimer's disease, vascular dementia, Parkinson's disease, demyelinating disease, encephalopathy of any cause, history of significant alcohol or drug abuse).
- •Pregnancy or lactation.
- •Acute or chronic renal failure with creatinine clearance <30 mL/min.
- •Allergy or any condition that represents a contraindication for the administration of Cerebrolysin.
- •Treatment with another investigational drug within the past 30 days that may interfere with the study drug.
研究组 & 干预措施
Intravenous thrombolysis and cerebrolysin
Group 1: 20 patients with previous intravenous thrombolysis (IVT) in the qualifying stroke and who agreed to receive and got selected (through randomization) cerebrolysin.
Cerebrolysin would be prepared according to manufacturer's instructions: 30 mL of cerebrolysin in 100 ml of saline solution every 24 hours to a minimum of 10 days and a maximum of 14 days
干预措施: Cerebrolysin (Drug)
Intravenous thrombolysis and cerebrolysin
Group 1: 20 patients with previous intravenous thrombolysis (IVT) in the qualifying stroke and who agreed to receive and got selected (through randomization) cerebrolysin.
Cerebrolysin would be prepared according to manufacturer's instructions: 30 mL of cerebrolysin in 100 ml of saline solution every 24 hours to a minimum of 10 days and a maximum of 14 days
干预措施: Brain-MRI with contrast after 10-14 days of cerebrolysin (Procedure)
Intravenous thrombolysis without cerebrolysin
Group 2 : 20 patients with previous IVT in the qualifying stroke and who agreed to receive cerebrolysin but they were not choose through randomization.
干预措施: Brain-MRI with contrast after 10-14 days of cerebrolysin (Procedure)
Patients with cerebrolysin without IVT
Group 3: 20 patients that they were not candidates to receive IVT (out of therapeutic window) but agreed to receive cerebrolysin (randomization not used)
Cerebrolysin would be prepared according to manufacturer's instructions: 30 mL of cerebrolysin in 100 ml of saline solution every 24 hours to a minimum of 10 days and a maximum of 14 days
干预措施: Cerebrolysin (Drug)
Patients with cerebrolysin without IVT
Group 3: 20 patients that they were not candidates to receive IVT (out of therapeutic window) but agreed to receive cerebrolysin (randomization not used)
Cerebrolysin would be prepared according to manufacturer's instructions: 30 mL of cerebrolysin in 100 ml of saline solution every 24 hours to a minimum of 10 days and a maximum of 14 days
干预措施: Brain-MRI with contrast after 10-14 days of cerebrolysin (Procedure)
结局指标
主要结局
Blood-Brain-Barrier Permeability after 10-14days of cerebrolysin in patients with AIS of the middle cerebral artery
时间窗: After 10-14 days of cerebrolysin
Blood-brain barrier (BBB) disruption will be measured using dynamic susceptibility contrast (DSC) magnetic resonance imaging (MRI).DSC MRI is collected during the injection of a gadolinium bolus and the majority of the change in recorded signal in this T2\*-weighted sequence is due to intravascular contrast. However, in the setting of gadolinium leakage through the BBB into the brain parenchyma, the recorded signal is altered by a T1 effect. An arrival time correction is performed to account for regional difference in blood flow after which the signal is separated into an intravascular and an extravascular component using a comparison with unaffected tissue. The extravascular component is captured with the metric K2 which reflects the fraction of the recorded signal that is due to gadolinium leakage and is a measure of BBB disruption.
次要结局
- Comparison of functional prognosis, using modified Rankin scale in patients with and withouth cerebrolysin(After 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge)
- Comparison of cognitive impairment, using Montreal Cognitive Assessment in patients with and withouth cerebrolysin(fter 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge)
- Comparison of clinical severity, using NIH Stroke Scale in patients with and withouth cerebrolysin(After 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge)
研究者
Juan Fernando Góngora Rivera, MD, PhD
Dr.med. Juan Fernando Góngora Rivera
Hospital Universitario Dr. Jose E. Gonzalez