Clinical Trial: SONOlysis in Risk REduction of Symptomatic and Silent Brain infarCtions dUring Cardiac surgEry

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Risk Reduction of Symptomatic and Silent Brain Infarctions During Cardiac Surgery Due to Ultrasound Activation of Endogenous Fibrinolytic System Using Transcranial Doppler

Brief Summary:

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 cardiac surgery (CS). 120 patients indicated for CS (CABG or valve replacement) 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 CEA or CS in 5% level of significance. Patients will be randomized - subgroup 1 will undergo a 40-240minute non-diagnostic TCD monitoring during CS, subgroup 2 will undergo interventions without TCD monitoring.

The aim of the project is a concordance with the aim No 1 of the Resort Program of a Research and Development: "Improvement of quality of life of patients using the modern therapeutic methods but with relative small positive effect of quality of life". The aim of the project is in concordance with a priority of announced public grant competition: "Development of the new therapeutic methods of cardiovascular disorders, especially coronary heart disease and stroke". Confirmation of our hypothesis that sonothrombolysis is able to activate endogenous fibrinolytic system during CS with consecutive reduction of the number and volume of brain infarcts, can lead to the increase of the safety of CS in patients. We can presume that up to 50% of patients indicated for CS can be treated using these methods in the future.


Detailed Summary:

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 CS.

The aim of the project is a concordance with the aim No 1 of the Resort program of a research and development in the years 2010-2015: "Improvement of quality of life of patients using the modern therapeutic methods but with relative small positive effect of quality of life". The aim of the project is in concordance with a priority of announced public grant competition: "Development of the new therapeutic methods of cardiovascular disorders, especially coronary heart disease and stroke".

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 durin sonothrombolysis (TCD monitoring) during CS 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 in the territory of the monitored MCA.

120 patients indicated for CS will be enrolled into the study in order to demonstrate a twenty-percent risk reduction of number and volume of brain infarctions in the territory of athe monitored MCA detected using MRI examination 24 hours after CS in 5% level of statistical significance. Patients will be randomized into 2 subgroups. Subgroup 1 will unde
Sponsor: University Hospital Ostrava

Current Primary Outcome: Number od Participants With New Brain Infarction in the Monitored MCA Territory Detected Using MRI [ Time Frame: 24 hours after intervention ]

to demonstrate a twenty-percent risk reduction of number and volume of brain infarctions and brain infarctions > 0.5 cm3 in the monitored MCA territory in sonolysis group detected using MRI examination 24 hours after cardiac surgery in 5% level of statistical significance


Original Primary Outcome: New brain infarction detected using MRI [ Time Frame: 24 hours after intervention ]

to demonstrate a twenty-percent risk reduction of number and volume of brain infarctions and brain infarctions > 0.5 cm3 in sonolysis group detected using MRI examination 24 hours after cardiac surgery in 5% level of statistical significance


Current Secondary Outcome:

  • Cognitive Decline [ Time Frame: 30 days after intervention ]

    To demonstrate an effect of sonolysis on the reduction of cognitive decline after cardiac surgery measured by ACE-R.

    Adenbook´s cognitive examination - revised (ACE-R) can aquire value 0 to 100. Higher value represents better cognitive functions.

  • Number of Participants With Clinical Manifested Brain Infarction [ Time Frame: 30 days after intervention ]
    to demonstrate an effect of sonolysis on the reduction of risk of clinically stroke due to the activation of endogenous fibrinolytic system during cardiac surgery


Original Secondary Outcome:

  • Cognitive Decline [ Time Frame: 7 and 30 days after intervention ]
    to demonstrate an effect of sonolysis on the reduction of cognitive decline after cardiac surgery measured by ADAS, MMSE, Clock Drawing Test and Verbal Fluency Test
  • Clinical manifested brain infarction [ Time Frame: 24 hours and 30 days after intervention ]
    to demonstrate an effect of sonolysis on the reduction of risk of clinically stroke due to the activation of endogenous fibrinolytic system during cardiac surgery


Information By: University Hospital Ostrava

Dates:
Date Received: April 23, 2012
Date Started: September 2012
Date Completion:
Last Updated: July 24, 2016
Last Verified: August 2015