Sonolysis in Risk Reduction of Symptomatic and Silent Brain Infarctions During Cardiac Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by University Hospital Ostrava
Sponsor:
Collaborators:
Palacky University
Ministry of Health, Czech Republic
Information provided by (Responsible Party):
University Hospital Ostrava
ClinicalTrials.gov Identifier:
NCT01591018
First received: April 23, 2012
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Coronary Artery Bypass Graft Redo
Heart Valve Diseases
Procedure: sonolysis
Procedure: cardiac surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Risk Reduction of Symptomatic and Silent Brain Infarctions During Cardiac Surgery Due to Ultrasound Activation of Endogenous Fibrinolytic System Using Transcranial Doppler Monitoring

Resource links provided by NLM:


Further study details as provided by University Hospital Ostrava:

Primary Outcome Measures:
  • New brain infarction detected using MRI [ Time Frame: 24 hours after intervention ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Cognitive decline [ Time Frame: 7 and 30 days after intervention ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 120
Study Start Date: April 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cardiac surgery with sonolysis
cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)
Procedure: sonolysis
continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes
Other Names:
  • sonolysis
  • sonothrombolysis
  • sonothrombotripsy
Procedure: cardiac surgery
coronary artery bypass graft (CABG) heart valve replacement
Other Names:
  • coronary artery bypass graft (CABG)
  • heart valve replacement
Placebo Comparator: cardiac surgery without sonolysis
cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)
Procedure: cardiac surgery
coronary artery bypass graft (CABG) heart valve replacement
Other Names:
  • coronary artery bypass graft (CABG)
  • heart valve replacement

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 40-90 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,
  • CS will be performed as an elective surgery with an extracorporeal circulation

Exclusion Criteria:

  • contra-indication for MRI examination (pace-maker, implanted metal material, claustrophobia),
  • emergent surgery,
  • acute myocardial infarction,
  • combined cardiac surgery,
  • combined cardiac and carotid surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591018

Contacts
Contact: David Skoloudik, MD, PhD 00420597375613 skoloudik@hotmail.com
Contact: Martin Kuliha, MD 00420597375630 martin.kuliha@email.cz

Locations
Czech Republic
University Hospital Ostrava Recruiting
Ostrava, Czech Republic, 70852
Contact: David Skoloudik, MD, PhD    00420597375613    skoloudik@email.cz   
Contact: Martin Kuliha, MD    00420597375630    martin.kuliha@email.cz   
Sponsors and Collaborators
University Hospital Ostrava
Palacky University
Ministry of Health, Czech Republic
Investigators
Principal Investigator: David Skoloudik, MD, PhD University Hospital Ostrava
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT01591018     History of Changes
Other Study ID Numbers: NT13498-4/2012
Study First Received: April 23, 2012
Last Updated: May 2, 2012
Health Authority: Czech Republic: Ethics Committee

Keywords provided by University Hospital Ostrava:
sonolysis, brain infarction, prevention, cardiac surgery

Additional relevant MeSH terms:
Brain Infarction
Heart Valve Diseases
Infarction
Brain Diseases
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Heart Diseases
Ischemia
Necrosis
Nervous System Diseases
Pathologic Processes
Stroke
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014