Trial Outcomes & Findings for SONOlysis in Risk REduction of Symptomatic and Silent Brain infarCtions dUring Cardiac surgEry (NCT NCT01591018)
NCT ID: NCT01591018
Last Updated: 2020-10-30
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
120 participants
Primary outcome timeframe
24 hours after intervention
Results posted on
2020-10-30
Participant Flow
Participant milestones
| Measure |
Cardiac Surgery With Sonolysis
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 Without Sonolysis
cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)
cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
60
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SONOlysis in Risk REduction of Symptomatic and Silent Brain infarCtions dUring Cardiac surgEry
Baseline characteristics by cohort
| Measure |
Cardiac Surgery With Sonolysis
n=60 Participants
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 Without Sonolysis
n=60 Participants
cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)
cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.5 years
n=93 Participants
|
69.0 years
n=4 Participants
|
68 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
69 Participants
n=27 Participants
|
|
Arterial Hypertension
Participants with Arterial Hypertension
|
48 participants
n=93 Participants
|
47 participants
n=4 Participants
|
95 participants
n=27 Participants
|
|
Arterial Hypertension
Participants without Arterial Hypertension
|
12 participants
n=93 Participants
|
13 participants
n=4 Participants
|
25 participants
n=27 Participants
|
|
Diabetes Mellitus
Participants with Arterial Hypertension
|
23 participants
n=93 Participants
|
19 participants
n=4 Participants
|
42 participants
n=27 Participants
|
|
Diabetes Mellitus
Participants without Arterial Hypertension
|
37 participants
n=93 Participants
|
41 participants
n=4 Participants
|
78 participants
n=27 Participants
|
|
Hyperlipidemia
Participants with Hyperlipidemia
|
33 participants
n=93 Participants
|
38 participants
n=4 Participants
|
71 participants
n=27 Participants
|
|
Hyperlipidemia
Participants without Hyperlipidemia
|
27 participants
n=93 Participants
|
22 participants
n=4 Participants
|
49 participants
n=27 Participants
|
|
Coronary Heart Disease
Participants with Coronary Heart Disease
|
42 participants
n=93 Participants
|
40 participants
n=4 Participants
|
82 participants
n=27 Participants
|
|
Coronary Heart Disease
Participants without Coronary Heart Disease
|
18 participants
n=93 Participants
|
20 participants
n=4 Participants
|
38 participants
n=27 Participants
|
|
Myocardial Infarction in History
Participants with Myocardial Infarction
|
14 participants
n=93 Participants
|
12 participants
n=4 Participants
|
26 participants
n=27 Participants
|
|
Myocardial Infarction in History
Participants without Myocardial Inf.arction
|
46 participants
n=93 Participants
|
48 participants
n=4 Participants
|
94 participants
n=27 Participants
|
|
Atrial Fibrillation
Participants with Atrial Fibrillation
|
33 participants
n=93 Participants
|
30 participants
n=4 Participants
|
63 participants
n=27 Participants
|
|
Atrial Fibrillation
Participants without Atrial Fibrillation
|
27 participants
n=93 Participants
|
30 participants
n=4 Participants
|
57 participants
n=27 Participants
|
|
Transient Ischemic Attack (TIA) or Stroke
Participants with TIA or Stroke
|
3 participants
n=93 Participants
|
3 participants
n=4 Participants
|
6 participants
n=27 Participants
|
|
Transient Ischemic Attack (TIA) or Stroke
Participants without TIA or Stroke
|
57 participants
n=93 Participants
|
57 participants
n=4 Participants
|
114 participants
n=27 Participants
|
|
Smoking
Smokers
|
6 participants
n=93 Participants
|
6 participants
n=4 Participants
|
12 participants
n=27 Participants
|
|
Smoking
Non-smokers
|
54 participants
n=93 Participants
|
54 participants
n=4 Participants
|
108 participants
n=27 Participants
|
|
Alcohol abuse
Alcohol Abuse Participants
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Alcohol abuse
Abstinent or Social Drinker Participants
|
59 participants
n=93 Participants
|
60 participants
n=4 Participants
|
119 participants
n=27 Participants
|
|
Internal carotid artery (ICA) stenosis ≥ 50%
Participants with ICA Stenosis
|
6 participants
n=93 Participants
|
4 participants
n=4 Participants
|
10 participants
n=27 Participants
|
|
Internal carotid artery (ICA) stenosis ≥ 50%
Participants without ICA Stenosis
|
54 participants
n=93 Participants
|
56 participants
n=4 Participants
|
110 participants
n=27 Participants
|
|
Type of surgery
Coronary Artery Bypass Graft
|
31 participants
n=93 Participants
|
29 participants
n=4 Participants
|
60 participants
n=27 Participants
|
|
Type of surgery
Valve Surgery
|
29 participants
n=93 Participants
|
31 participants
n=4 Participants
|
60 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 24 hours after interventionto 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
Outcome measures
| Measure |
Cardiac Surgery With Sonolysis
n=60 Participants
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 Without Sonolysis
n=60 Participants
cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)
cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement
|
|---|---|---|
|
Number od Participants With New Brain Infarction in the Monitored MCA Territory Detected Using MRI
Participants with new infraction
|
8 participants
|
16 participants
|
|
Number od Participants With New Brain Infarction in the Monitored MCA Territory Detected Using MRI
Participants without new infraction
|
52 participants
|
44 participants
|
SECONDARY outcome
Timeframe: 30 days after interventionPopulation: 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.
To demonstrate an effect of sonolysis on the reduction of cognitive decline after cardiac surgery measured by Adenbook´s Cognitive Examination - revised (ACE-R)ACE-R. Adenbook´s Cognitive Examination - revised (ACE-R) can aquire value 0 to 100. Higher value represents better cognitive functions.
Outcome measures
| Measure |
Cardiac Surgery With Sonolysis
n=50 Participants
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 Without Sonolysis
n=50 Participants
cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)
cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement
|
|---|---|---|
|
Cognitive Decline
|
80 units on a scale
Interval 74.0 to 85.0
|
82 units on a scale
Interval 76.0 to 87.0
|
SECONDARY outcome
Timeframe: 30 days after interventionPopulation: All enrolled participants were analyzed
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
Outcome measures
| Measure |
Cardiac Surgery With Sonolysis
n=60 Participants
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 Without Sonolysis
n=60 Participants
cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)
cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement
|
|---|---|---|
|
Number of Participants With Clinical Manifested Brain Infarction
Participants with clinical manifested infarction
|
0 participants
|
2 participants
|
|
Number of Participants With Clinical Manifested Brain Infarction
Participants without clinical manifest. infarction
|
60 participants
|
58 participants
|
Adverse Events
Cardiac Surgery With Sonolysis
Serious events: 42 serious events
Other events: 0 other events
Deaths: 0 deaths
Cardiac Surgery Without Sonolysis
Serious events: 44 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cardiac Surgery With Sonolysis
n=60 participants at risk
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 Without Sonolysis
n=60 participants at risk
cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)
cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
5.0%
3/60 • Number of events 3 • 30 Days
Serious adverse events.
|
1.7%
1/60 • Number of events 1 • 30 Days
Serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Infection of respiratory system
|
41.7%
25/60 • Number of events 25 • 30 Days
Serious adverse events.
|
40.0%
24/60 • Number of events 24 • 30 Days
Serious adverse events.
|
|
Infections and infestations
Other infections
|
16.7%
10/60 • Number of events 12 • 30 Days
Serious adverse events.
|
18.3%
11/60 • Number of events 14 • 30 Days
Serious adverse events.
|
|
Renal and urinary disorders
Renal failure
|
3.3%
2/60 • Number of events 2 • 30 Days
Serious adverse events.
|
1.7%
1/60 • Number of events 1 • 30 Days
Serious adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal disease
|
6.7%
4/60 • Number of events 4 • 30 Days
Serious adverse events.
|
11.7%
7/60 • Number of events 7 • 30 Days
Serious adverse events.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place