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Phase 3 Completed N=120 Randomized Single-blind Prevention

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

Coronary Artery Bypass Graft Redo · Heart Valve Diseases
Source: ClinicalTrials.gov NCT01591018 ↗
Enrolled (actual)
120
Serious AEs
71.7%
Results posted
Sep 2016
Primary outcomePrimary: Number od Participants With New Brain Infarction in the Monitored MCA Territory Detected Using MRI — 8; 16; 52; 44 participants — p=<0.05
◆ Published Evidence
Emerging
6citations · ~1 / year
Sonolysis in Prevention of Brain Infarction During Cardiac Surgery (SONORESCUE): Randomized, Controlled Trial.
Medicine · 2016 · Open access · Likely link

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.

Linked Publications

  • Sonolysis in Prevention of Brain Infarction During Cardiac Surgery (SONORESCUE): Randomized, Controlled Trial.
    Medicine · 2016 · 6 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Number od Participants With New Brain Infarction in the Monitored MCA Territory Detected Using MRI
8; 16; 52; 44 <0.05 sig
SECONDARY
Cognitive Decline
80; 82
SECONDARY
Number of Participants With Clinical Manifested Brain Infarction
0; 2; 60; 58

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01591018) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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