Clinical Trial: Sonolysis in Risk Reduction of Symptomatic and Silent Brain Infarctions During Coronary Stenting

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Sonolysis in Risk Reduction of Symptomatic and Silent Brain Infarctions During Coronary Stenting Due to Ultrasound Activation of Endogenous Fibrinolytic System Using Trans

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 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.


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 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 i
Sponsor: University Hospital Ostrava

Current Primary Outcome: New infarction [ Time Frame: 24 hours after intervention ]

New brain infarction detected using magnetic resonance diffusion weighted images (MRI-DWI)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cognitive functions changes, measured by ADAS, MMSE, Clock Drawing Test and Verbal Fluency Test [ Time Frame: 7 and 30 days after interventions ]
    Cognitive decline measured by ADAS, MMSE, Clock Drawing Test and Verbal Fluency Test
  • Large new infarction, infarction ≥0.5 mL detected using magnetic resonance diffusion weighted images (MRI-DWI) [ Time Frame: 24 hours after intervention ]
    New brain infarction ≥0.5 mL detected using magnetic resonance diffusion weighted images (MRI-DWI)
  • Volume of new brain infarction, detected using magnetic resonance diffusion weighted images (MRI-DWI) [ Time Frame: 24 hours after intervention ]
    Volume of new brain infarctions detected using magnetic resonance diffusion weighted images (MRI-DWI)
  • 30-days morbidity and mortality [ Time Frame: 30 days after intervention ]
    stroke, TIA, myocardial infarctions and death during 30 days after intervention
  • Symptomatic intracerebral hemorrhage, detected using magnetic resonance (MRI) [ Time Frame: 24 hours after intervention ]
    Intracerebral hemorrhage with worsening of neurological status (≥ 4 points in NIHSS scale) detected using magnetic resonance (MRI)


Original Secondary Outcome: Same as current

Information By: University Hospital Ostrava

Dates:
Date Received: November 23, 2014
Date Started: April 2015
Date Completion: September 2017
Last Updated: July 24, 2016
Last Verified: July 2016