Cerebral Microembolism in Cardiology (ZEMEK)

November 7, 2022 updated by: Gabor Erdös, University Hospital Inselspital, Berne

Cerebral Microembolism in Interventional Cardiology Procedures

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Department of anesthesiology and pain medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing Interventional cardiology procedure (TAVI, MitraClip, TricuspidalClip)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
intraoperative phase, expected to be approx. 4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
intraoperative phase, expected to be approx. 4 hours
Cerebral hemispheric differences (left vs. right)
Time Frame: intraoperative phase, expected to be approx. 4 hours
intraoperative phase, expected to be approx. 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2018

Primary Completion (Actual)

February 24, 2022

Study Completion (Actual)

November 6, 2022

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

January 10, 2019

First Posted (Actual)

January 14, 2019

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-01066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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