Sonolysis in Risk Reduction of Symptomatic and Silent Brain Infarctions During Cardiac Surgery
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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 |
- 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
- 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:
Procedure: cardiac surgery
coronary artery bypass graft (CABG) heart valve replacement
Other Names:
|
|
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:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 40 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: David Skoloudik, MD, PhD | 00420597375613 | skoloudik@hotmail.com |
| Contact: Martin Kuliha, MD | 00420597375630 | martin.kuliha@email.cz |
| 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 | |
| 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:
|
Heart Valve Diseases Infarction Brain Infarction Heart Diseases Cardiovascular Diseases Ischemia Pathologic Processes Necrosis |
Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Stroke Vascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013