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Trial record 25 of 1643 for:    Slovakia

Sonolysis in Risk Reduction of Symptomatic and Silent Brain Infarctions During Coronary Stenting

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ClinicalTrials.gov Identifier: NCT02351050
Recruitment Status : Completed
First Posted : January 30, 2015
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital Ostrava

Brief 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 angioplasty and stenting of coronary arteries. 120 patients indicated for coronary angioplasty and stenting 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 cardiac endovascular treatment in 5% level of significance. Patients will be randomized - subgroup 1 will undergo a 40-240 minute non-diagnostic TCD monitoring during endovascular procedure, subgroup 2 will undergo interventions without TCD monitoring.

Confirmation of our hypothesis that sonothrombolysis is able to activate endogenous fibrinolytic system during coronary angioplasty and stenting with consecutive reduction of the number and volume of brain infarcts, can lead to the increase of the safety these patients. We can presume that up to 50% of patients indicated for endovasular heart treatment can be treated using these methods in the future.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Sonolysis Other: Sham procedure Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Sonolysis in Risk Reduction of Symptomatic and Silent Brain Infarctions During Coronary Stenting Due to Ultrasound Activation of Endogenous Fibrinolytic System Using Transcranial Doppler Monitoring
Actual Study Start Date : April 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : November 2017

Arm Intervention/treatment
Experimental: Sonolysis
continual transcranial Doppler monitoring with maximal intensity during endovascular procedure
Device: Sonolysis
continual transcranial Doppler monitoring of middle cerebral artery
Other Name: sonothrombolysis, sonothrombotripsy

Placebo Comparator: placebo
sham transcranial Doppler monitoring during endovascular procedure
Other: Sham procedure
sham transcranial Doppler monitoring of middle cerebral artery




Primary Outcome Measures :
  1. New infarction [ Time Frame: 24 hours after intervention ]
    New brain infarction detected using magnetic resonance diffusion weighted images (MRI-DWI)


Secondary Outcome Measures :
  1. Cognitive functions changes, measured by ADAS, MMSE, Clock Drawing Test and Verbal Fluency Test [ Time Frame: 7 and 30 days after interventions ]
    Cognitive decline measured by ADAS, MMSE, Clock Drawing Test and Verbal Fluency Test

  2. Large new infarction, infarction ≥0.5 mL detected using magnetic resonance diffusion weighted images (MRI-DWI) [ Time Frame: 24 hours after intervention ]
    New brain infarction ≥0.5 mL detected using magnetic resonance diffusion weighted images (MRI-DWI)

  3. Volume of new brain infarction, detected using magnetic resonance diffusion weighted images (MRI-DWI) [ Time Frame: 24 hours after intervention ]
    Volume of new brain infarctions detected using magnetic resonance diffusion weighted images (MRI-DWI)

  4. 30-days morbidity and mortality [ Time Frame: 30 days after intervention ]
    stroke, TIA, myocardial infarctions and death during 30 days after intervention

  5. Symptomatic intracerebral hemorrhage, detected using magnetic resonance (MRI) [ Time Frame: 24 hours after intervention ]
    Intracerebral hemorrhage with worsening of neurological status (≥ 4 points in NIHSS scale) detected using magnetic resonance (MRI)



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Ages Eligible for Study:   35 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 35-90 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
  • coronary angioplasty and stenting will be performed as an elective procedure

Exclusion Criteria:

  • contra-indication for MRI examination (pace-maker, implanted metal material, claustrophobia)
  • emergent coronary angioplasty and stenting

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02351050


Locations
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Slovakia
University Hospital Nitra
Nitra, Slovakia, 70852
Sponsors and Collaborators
University Hospital Ostrava
Investigators
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Study Chair: David Skoloudik, MD, Prof University Hospital Ostrava

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Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT02351050     History of Changes
Other Study ID Numbers: 13595
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University Hospital Ostrava:
sonolysis, brain infarction, coronary angioplasty
Additional relevant MeSH terms:
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Brain Infarction
Coronary Artery Disease
Infarction
Ischemia
Pathologic Processes
Necrosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke