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

NCT01591018 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-10-30

Study results available
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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.

Conditions

  • Coronary Artery Bypass Graft Redo
  • Heart Valve Diseases

Interventions

PROCEDURE

sonolysis

continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes

PROCEDURE

cardiac surgery

coronary artery bypass graft (CABG) heart valve replacement

Sponsors & Collaborators

  • Palacky University

    collaborator OTHER

  • Ministry of Health, Czech Republic

    collaborator OTHER_GOV

  • University Hospital Ostrava

    lead OTHER

Principal Investigators

  • David Skoloudik, MD, PhD · University Hospital Ostrava

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-12-31
Completion
2015-07-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01591018 on ClinicalTrials.gov