Cerebral Microembolism in Cardiology
ZEMEK
Cerebral Microembolism in Interventional Cardiology Procedures
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2018
CompletedStudy Start
First participant enrolled
October 24, 2018
CompletedFirst Posted
Study publicly available on registry
January 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2022
CompletedNovember 8, 2022
November 1, 2022
3.3 years
October 22, 2018
November 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Quality of cerebral microemboli (solid vs. gaseous)
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 Outcomes (2)
Quantity of cerebral microemboli load
intraoperative phase, expected to be approx. 4 hours
Cerebral hemispheric differences (left vs. right)
intraoperative phase, expected to be approx. 4 hours
Study Arms (3)
TAVI patients
Patients undergoing transfemoral TAVI
MitraClip patients
Patients undergoing MitraClip implantation
TricuspidalClip
Patients undergoing TricuspidalClip implantation
Interventions
Non-invasive measurement of cerebral embolic load and blood flow using TCD
Eligibility Criteria
Patients undergoing Interventional cardiology procedure (TAVI, MitraClip, TricuspidalClip)
You may qualify if:
- Age \> 18 years
- Interventional cardiology procedure (TAVI, MitraClip, TricuspidalClip)
You may not qualify if:
- Allergy to ultrasound gel or materials contained in the TCD probe
- Missing temporal bone window
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine
Bern, 3010, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 22, 2018
First Posted
January 14, 2019
Study Start
October 24, 2018
Primary Completion
February 24, 2022
Study Completion
November 6, 2022
Last Updated
November 8, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share