SONOlysis in Risk REduction of Symptomatic and Silent Brain infarCtions dUring Cardiac surgEry
SONORESCUE
Risk Reduction of Symptomatic and Silent Brain Infarctions During Cardiac Surgery Due to Ultrasound Activation of Endogenous Fibrinolytic System Using Transcranial Doppler Monitoring
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2012
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2012
CompletedFirst Posted
Study publicly available on registry
May 3, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
September 8, 2016
CompletedOctober 30, 2020
October 1, 2020
2.2 years
April 23, 2012
July 24, 2016
October 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number od Participants With New Brain Infarction in the Monitored MCA Territory Detected Using MRI
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
24 hours after intervention
Secondary Outcomes (2)
Cognitive Decline
30 days after intervention
Number of Participants With Clinical Manifested Brain Infarction
30 days after intervention
Study Arms (2)
cardiac surgery with sonolysis
EXPERIMENTALcardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)
cardiac surgery without sonolysis
PLACEBO COMPARATORcardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)
Interventions
continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes
coronary artery bypass graft (CABG) heart valve replacement
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- contra-indication for MRI examination (pace-maker, implanted metal material, claustrophobia),
- emergent surgery,
- acute myocardial infarction,
- combined cardiac surgery,
- combined cardiac and carotid surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Ostravalead
- Palacky Universitycollaborator
- Ministry of Health, Czech Republiccollaborator
Study Sites (1)
University Hospital Ostrava
Ostrava, Czech Republic, 70852, Czechia
Related Publications (1)
Skoloudik D, Hurtikova E, Brat R, Herzig R; SONORESCUE Trial Group. Sonolysis in Prevention of Brain Infarction During Cardiac Surgery (SONORESCUE): Randomized, Controlled Trial. Medicine (Baltimore). 2016 May;95(20):e3615. doi: 10.1097/MD.0000000000003615.
PMID: 27196464DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Skoloudik
- Organization
- University Hospital Ostrava
Study Officials
- PRINCIPAL INVESTIGATOR
David Skoloudik, MD, PhD
University Hospital Ostrava
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2012
First Posted
May 3, 2012
Study Start
September 1, 2012
Primary Completion
December 1, 2014
Study Completion
July 1, 2015
Last Updated
October 30, 2020
Results First Posted
September 8, 2016
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share