Sonolysis in Risk Reduction of Symptomatic and Silent Brain Infarctions During Coronary Stenting Due to Ultrasound Activation of Endogenous Fibrinolytic System Using Transcranial Doppler Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- New infarction
研究概览
简要总结
The aim of the project is to demonstrate a fibrinolytic effect of sonothrombolysis (continual transcranial Doppler monitoring) using 2 MHz diagnostic probe on the reduction of risk of brain infarctions due to the activation of endogenous fibrinolytic system during angioplasty and stenting of coronary arteries. 120 patients indicated for coronary angioplasty and stenting will be enrolled into the study in order to demonstrate a twenty-percent risk reduction of number and volume of brain infarctions detected using MRI examination 24 hours after cardiac endovascular treatment in 5% level of significance. Patients will be randomized - subgroup 1 will undergo a 40-240 minute non-diagnostic TCD monitoring during endovascular procedure, subgroup 2 will undergo interventions without TCD monitoring.
Confirmation of our hypothesis that sonothrombolysis is able to activate endogenous fibrinolytic system during coronary angioplasty and stenting with consecutive reduction of the number and volume of brain infarcts, can lead to the increase of the safety these patients. We can presume that up to 50% of patients indicated for endovasular heart treatment can be treated using these methods in the future.
详细描述
AIM OF THE PROJECT The aim of the project is to demonstrate an effect of continual TCD monitoring using 2 MHz diagnostic probe with maximal diagnostic energy on the reduction of risk of brain microinfarctions due to the activation of endogenous fibrinolytic system and mechanical effect on emboli during coronary stenting.
HYPOTHESIS Sonothrombolysis lead to activation of fibrinolytic system in both healthy volunteers and acute stroke patients. In acute stroke patients, mechanical effect of sonothrombolysis is the second effect leading to acceleration of occluded artery recanalization. We hypothesize that combination of mechanical effect and activation of fibrinolytic system during sonothrombolysis (TCD monitoring) during coronary stenting will lead to recanalization of small arterial occlusions caused by microembolization during intervention. The result will be reduction of volume and the number of brain infarctions.
120 patients indicated for coronary stenting will be enrolled into the study in order to demonstrate a twenty-percent risk reduction of number and volume of brain infarctions detected using MRI examination 24 hours after procedure in 5% level of statistical significance. Patients will be randomized into 2 subgroups. Subgroup 1 will undergo non-diagnostic bilateral TCD monitoring during coronary stenting. Subgroup 2 will undergo coronary stenting without TCD monitoring.
PATIENTS AND METHODS Patients: 120 patients indicated for coronary angioplasty and stenting will be enrolled into the study during a 3-year period. All 120 patients will be randomized for standard coronary angioplasty and stenting and TCD monitored.
Clinical examinations: Physical and neurological examinations including evaluating of neurological impairment of neurological deficit in NIHSS scale, modified Rankin scale and cognitive testing (Mini Mental State Examination, Clock drawing test) will be performed before and 24 - 72 hours after coronary angioplasty and stenting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 35-90 years
- •sufficient temporal bone window for TCD with detectable blood flow in MCA
- •independent patient (modified Rankin score 0-2)
- •informed consent signed by the patient
- •coronary angioplasty and stenting will be performed as an elective procedure
排除标准
- •contra-indication for MRI examination (pace-maker, implanted metal material, claustrophobia)
- •emergent coronary angioplasty and stenting
结局指标
主要结局
New infarction
时间窗: 24 hours after intervention
New brain infarction detected using magnetic resonance diffusion weighted images (MRI-DWI)
次要结局
- Cognitive functions changes, measured by ADAS, MMSE, Clock Drawing Test and Verbal Fluency Test(7 and 30 days after interventions)
- Large new infarction, infarction ≥0.5 mL detected using magnetic resonance diffusion weighted images (MRI-DWI)(24 hours after intervention)
- Volume of new brain infarction, detected using magnetic resonance diffusion weighted images (MRI-DWI)(24 hours after intervention)
- 30-days morbidity and mortality(30 days after intervention)
- Symptomatic intracerebral hemorrhage, detected using magnetic resonance (MRI)(24 hours after intervention)