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SONOlysis in Risk REduction of Symptomatic and Silent Brain infarCtions dUring Cardiac surgEry (SONORESCUE)

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ClinicalTrials.gov Identifier: NCT01591018
Recruitment Status : Completed
First Posted : May 3, 2012
Results First Posted : September 8, 2016
Last Update Posted : September 8, 2016
Sponsor:
Collaborators:
Palacky University
Ministry of Health, Czech Republic
Information provided by (Responsible Party):
University Hospital Ostrava

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.


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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : September 2012
Primary Completion Date : December 2014
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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:
  • 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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


  2. 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



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01591018


Locations
Czech Republic
University Hospital Ostrava
Ostrava, Czech Republic, 70852
Sponsors and Collaborators
University Hospital Ostrava
Palacky University
Ministry of Health, Czech Republic
Investigators
Principal Investigator: David Skoloudik, MD, PhD University Hospital Ostrava

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT01591018     History of Changes
Other Study ID Numbers: NT13498-4/2012
First Posted: May 3, 2012    Key Record Dates
Results First Posted: September 8, 2016
Last Update Posted: September 8, 2016
Last Verified: August 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

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