Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Coronary Artery Bypass Graft Redo
Heart Valve Diseases
Interventions Procedure: sonolysis
Procedure: cardiac surgery
Enrollment 120
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cardiac Surgery With Sonolysis Cardiac Surgery Without Sonolysis
Hide Arm/Group Description

cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)

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

cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement

cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)

cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement

Period Title: Overall Study
Started 60 60
Completed 60 60
Not Completed 0 0
Arm/Group Title Cardiac Surgery With Sonolysis Cardiac Surgery Without Sonolysis Total
Hide Arm/Group Description

cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)

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

cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement

cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)

cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement

Total of all reporting groups
Overall Number of Baseline Participants 60 60 120
Hide Baseline Analysis Population Description
In total, 120 of 214 screened patients fulfilled the inclusion criteria. Subjects were allocated to the sonolysis or control group randomly and equally.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 60 participants 60 participants 120 participants
66.5
(61 to 71)
69.0
(64 to 73)
68
(62 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Female
23
  38.3%
28
  46.7%
51
  42.5%
Male
37
  61.7%
32
  53.3%
69
  57.5%
Arterial Hypertension  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Participants with Arterial Hypertension 48 47 95
Participants without Arterial Hypertension 12 13 25
Diabetes Mellitus  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Participants with Arterial Hypertension 23 19 42
Participants without Arterial Hypertension 37 41 78
Hyperlipidemia  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Participants with Hyperlipidemia 33 38 71
Participants without Hyperlipidemia 27 22 49
Coronary Heart Disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Participants with Coronary Heart Disease 42 40 82
Participants without Coronary Heart Disease 18 20 38
Myocardial Infarction in History  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Participants with Myocardial Infarction 14 12 26
Participants without Myocardial Inf.arction 46 48 94
Atrial Fibrillation  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Participants with Atrial Fibrillation 33 30 63
Participants without Atrial Fibrillation 27 30 57
Transient Ischemic Attack (TIA) or Stroke  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Participants with TIA or Stroke 3 3 6
Participants without TIA or Stroke 57 57 114
Smoking  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Smokers 6 6 12
Non-smokers 54 54 108
Alcohol abuse  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Alcohol Abuse Participants 1 0 1
Abstinent or Social Drinker Participants 59 60 119
Internal carotid artery (ICA) stenosis ≥ 50%  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Participants with ICA Stenosis 6 4 10
Participants without ICA Stenosis 54 56 110
Type of surgery  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Coronary Artery Bypass Graft 31 29 60
Valve Surgery 29 31 60
1.Primary Outcome
Title Number od Participants With New Brain Infarction in the Monitored MCA Territory Detected Using MRI
Hide Description 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
Time Frame 24 hours after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cardiac Surgery With Sonolysis Cardiac Surgery Without Sonolysis
Hide Arm/Group Description:

cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)

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

cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement

cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)

cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement

Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: participants
Participants with new infraction 8 16
Participants without new infraction 52 44
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cardiac Surgery With Sonolysis, Cardiac Surgery Without Sonolysis
Comments Sample size was based on an expected 20% reduction of new ischemic lesions on DW–MRI in the sonolysis group (estimated prevalence, 10%) compared with the control group (estimated prevalence, 30%).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments Pre-study calculations using chi-square test with a continuity correction showed that ≥60 patients in each group were needed to reach a significant difference with an alpha value of 0.05 (two-tailed) and a beta value of 0.8.
Method Chi-squared, Corrected
Comments [Not Specified]
2.Secondary Outcome
Title Cognitive Decline
Hide Description

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.

Time Frame 30 days after intervention
Hide Outcome Measure Data
Hide Analysis Population Description

50 out of 60 participants completed all cognitive tests in cardiac surgery with sonolysis group.

50 out of 60 participants completed all cognitive tests in cardiac surgery without sonolysis group.

Arm/Group Title Cardiac Surgery With Sonolysis Cardiac Surgery Without Sonolysis
Hide Arm/Group Description:

cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)

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

cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement

cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)

cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement

Overall Number of Participants Analyzed 50 50
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
80
(74 to 85)
82
(76 to 87)
3.Secondary Outcome
Title Number of Participants With Clinical Manifested Brain Infarction
Hide Description 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
Time Frame 30 days after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants were analyzed
Arm/Group Title Cardiac Surgery With Sonolysis Cardiac Surgery Without Sonolysis
Hide Arm/Group Description:

cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)

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

cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement

cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)

cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement

Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: participants
Participants with clinical manifested infarction 0 2
Participants without clinical manifest. infarction 60 58
Time Frame 30 Days
Adverse Event Reporting Description Serious adverse events.
 
Arm/Group Title Cardiac Surgery With Sonolysis Cardiac Surgery Without Sonolysis
Hide Arm/Group Description

cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)

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

cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement

cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)

cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement

All-Cause Mortality
Cardiac Surgery With Sonolysis Cardiac Surgery Without Sonolysis
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Cardiac Surgery With Sonolysis Cardiac Surgery Without Sonolysis
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/60 (70.00%)      44/60 (73.33%)    
Cardiac disorders     
Cardiac arrest  1  3/60 (5.00%)  3 1/60 (1.67%)  1
Gastrointestinal disorders     
Gastrointestinal disease  1  4/60 (6.67%)  4 7/60 (11.67%)  7
Infections and infestations     
Other infections  1  10/60 (16.67%)  12 11/60 (18.33%)  14
Renal and urinary disorders     
Renal failure  1  2/60 (3.33%)  2 1/60 (1.67%)  1
Respiratory, thoracic and mediastinal disorders     
Infection of respiratory system  1  25/60 (41.67%)  25 24/60 (40.00%)  24
Indicates events were collected by systematic assessment
1
Term from vocabulary, SNOMED CT
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cardiac Surgery With Sonolysis Cardiac Surgery Without Sonolysis
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/60 (0.00%)      0/60 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Skoloudik
Organization: University Hospital Ostrava
Phone: 00420597375630
EMail: skoloudik@hotmail.com
Layout table for additonal information
Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT01591018    
Other Study ID Numbers: NT13498-4/2012
First Submitted: April 23, 2012
First Posted: May 3, 2012
Results First Submitted: July 24, 2016
Results First Posted: September 8, 2016
Last Update Posted: September 8, 2016