Sonolysis in Prevention of Brain Infarctions During Carotid Endarterectomy and Carotid Stenting
This study is currently recruiting participants.
Verified May 2012 by University Hospital Ostrava
Sponsor:
University Hospital Ostrava
Collaborator:
Palacky University
Information provided by (Responsible Party):
Vaclav Prochazka, MD, PhD. MSc, University Hospital Ostrava
ClinicalTrials.gov Identifier:
NCT01591005
First received: April 23, 2012
Last updated: May 2, 2012
Last verified: May 2012
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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 carotid endarterectomy (CEA) and carotid stenting (CS). 80 patients indicated for CEA (40 patients) and CS (40 patients) 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 60minute non-diagnostic TCD monitoring during CEA or CS, subgroup 2 will undergo interventions without TCD monitoring. The second aim is to compare number of brain infarctions detected using MRI between CEA and CS patients.
Confirmation of the investigators hypothesis that sonothrombolysis is able to activate endogenous fibrinolytic system during CEA or CS with consecutive reduction of the number and volume of brain infarcts, can lead to the increase of the safety of CEA and CS in patients with internal carotid artery stenosis. The investigators can presume that up to 50% of patients indicated for CEA or CS can be treated using these methods in the future.
| Condition | Intervention | Phase |
|---|---|---|
|
Internal Carotid Artery Stenosis |
Procedure: sonolysis Procedure: endarterectomy Procedure: carotid stenting |
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 Carotid Endarterectomy and Carotid Stenting Due to Ultrasound Activation of Endogenous Fibrinolytic System Using Transcranial Doppler Monitoring |
Resource links provided by NLM:
Further study details as provided by University Hospital Ostrava:
Primary Outcome Measures:
- New brain infarction detected using MRI [ Time Frame: 24 hours after intervention ] [ Designated as safety issue: Yes ]The 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 CEA or CS in 5% level of statistical significance
Secondary Outcome Measures:
- New brain infarctions detected using MRI in endarterectomy and stenting groups [ Time Frame: 24 hours after intervention ] [ Designated as safety issue: No ]The number and volume of brain infarctions and brain infarctions >0.5 cm3 detected using MRI examination 24 hours after intervention between endarterectomy and stenting
- Cognitive decline [ Time Frame: 24 hours after intervention ] [ Designated as safety issue: No ]The reduction of cognitive decline after CEA and CS measured by ADAS, MMSE, Clock Drawing Test and Verbal Fluency Test using periprocedural sonolysis
- Clinical manifested brain infarction [ Time Frame: 24 hours and 30 days after intervention ] [ Designated as safety issue: Yes ]The reduction of risk of clinically stroke due to the activation of endogenous fibrinolytic system during CEA and CS using periprocedural sonolysis
| Estimated Enrollment: | 240 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CEA with sonolysis
endarterectomy with sonolysis (continual transcranial Doppler monitoring)
|
Procedure: sonolysis
continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
Other Names:
Procedure: endarterectomy
carotid endarterectomy
Other Name: carotid endarterectomy
|
|
Placebo Comparator: CEA without sonolysis
endarterectomy without sonolysis
|
Procedure: endarterectomy
carotid endarterectomy
Other Name: carotid endarterectomy
|
|
Experimental: carotid stenting with sonolysis
carotid stenting with sonolysis (continual transcranial Doppler monitoring)
|
Procedure: sonolysis
continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
Other Names:
Procedure: carotid stenting
percutaneous transluminal angioplasty and stenting
Other Names:
|
|
Placebo Comparator: carotid stenting without sonolysis
carotid stenting without sonolysis
|
Procedure: carotid stenting
percutaneous transluminal angioplasty and stenting
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- stenosis of internal carotid artery
- indication to endarterectomy or stenting
- age 40-80 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.
Exclusion Criteria:
- contraindication to MRI examination (pace-maker, implanted metal material, claustrophobia)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591005
Contacts
| Contact: David Skoloudik, MD, PhD | 00420597375613 | skoloudik@hotmail.com |
| Contact: Martin Kuliha, MD | 00420597375630 | martin.kuliha@email.cz |
Locations
| Czech Republic | |
| University Hospital Ostrava | Recruiting |
| Ostrava, Czech Republic, 70852 | |
| Contact: David Skoloudik, MD, PhD 00420597375613 skoloudik@hotmail.com | |
| Contact: Martin Kuliha, MD 00420597375630 martin.kuliha@email.cz | |
| Principal Investigator: David Skoloudik, MD, PhD | |
Sponsors and Collaborators
University Hospital Ostrava
Palacky University
Investigators
| Principal Investigator: | David Skoloudik, MD, PhD | University Hospital Ostrava |
More Information
Additional Information:
No publications provided
| Responsible Party: | Vaclav Prochazka, MD, PhD. MSc, Vaclav Prochazka, MD, PhD, MSc, University Hospital Ostrava |
| ClinicalTrials.gov Identifier: | NCT01591005 History of Changes |
| Other Study ID Numbers: | NT11386-5/2010 |
| Study First Received: | April 23, 2012 |
| Last Updated: | May 2, 2012 |
| Health Authority: | Czech Republic: Ethics Committee |
Keywords provided by University Hospital Ostrava:
|
sonolysis carotid endarterectomy stenting |
Additional relevant MeSH terms:
|
Carotid Stenosis Infarction Brain Infarction Carotid Artery Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Ischemia Pathologic Processes Necrosis Brain Ischemia Stroke |
ClinicalTrials.gov processed this record on May 23, 2013