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Cerebral Microembolism in Cardiology (ZEMEK)

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ClinicalTrials.gov Identifier: NCT03802760
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Gabor Erdös, University Hospital Inselspital, Berne

Brief Summary:
During different interventional cardiology procedures we aim to identify cerebral microemboli load. Further we aim to differentiate the quality and the quantity of cerebral microemboli.We will measure cerebral microemboli in different interventional phases, e.g. during valve deployment, rapid pacing, post-implantation.

Condition or disease Intervention/treatment
Cerebral Embolism Device: Transcranial Doppler (TCD) ultrasound measurement

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cerebral Microembolism in Interventional Cardiology Procedures
Actual Study Start Date : October 24, 2018
Estimated Primary Completion Date : October 24, 2020
Estimated Study Completion Date : December 24, 2020

Group/Cohort Intervention/treatment
TAVI patients
Patients undergoing transfemoral TAVI
Device: Transcranial Doppler (TCD) ultrasound measurement
Non-invasive measurement of cerebral embolic load and blood flow using TCD

MitraClip patients
Patients undergoing MitraClip implantation
Device: Transcranial Doppler (TCD) ultrasound measurement
Non-invasive measurement of cerebral embolic load and blood flow using TCD

TricuspidalClip
Patients undergoing TricuspidalClip implantation
Device: Transcranial Doppler (TCD) ultrasound measurement
Non-invasive measurement of cerebral embolic load and blood flow using TCD




Primary Outcome Measures :
  1. Quality of cerebral microemboli (solid vs. gaseous) [ Time Frame: intraoperative phase, expected to be approx. 4 hours ]
    The quality of cerebral microemboli is measured by Doppler ultrasonography which automatically detects and analyses the Doppler signal coming from the middle cerebral artery. According to the strength of signal reflection, the signal will be qualified as solid or gaseous.


Secondary Outcome Measures :
  1. Quantity of cerebral microemboli load [ Time Frame: intraoperative phase, expected to be approx. 4 hours ]
    The quantity of cerebral microemboli is measured by Doppler ultrasonography which automatically register the counts of solid and gaseous emboli.

  2. Cerebral hemispheric differences (left vs. right) [ Time Frame: intraoperative phase, expected to be approx. 4 hours ]


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing Interventional cardiology procedure (TAVI, MitraClip, TricuspidalClip)
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Interventional cardiology procedure (TAVI, MitraClip, TricuspidalClip)

Exclusion Criteria:

  • Allergy to ultrasound gel or materials contained in the TCD probe
  • Missing temporal bone window

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): NCT03802760


Contacts
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Contact: Gabor Erdoes, MD 00416322726 gabor.erdoes@insel.ch
Contact: Maximilian Pucklitzsch, MS maximilian.pucklitzsch@insel.ch

Locations
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Switzerland
Department of Anesthesiology and Pain Medicine Recruiting
Bern, Switzerland, 3010
Contact: Gabor Erdoes, MD PhD    0041316322726    gabor.erdoes@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
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Responsible Party: Gabor Erdös, Principal Investigator, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03802760    
Other Study ID Numbers: 2018-01066
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intracranial Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Intracranial Embolism and Thrombosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Thromboembolism