Cerebral Microembolism in Cardiology

Cerebral Embolism Clinical Trial

— ZEMEK  

Official title:

Cerebral Microembolism in Interventional Cardiology Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03802760
• Other study ID #: 2018-01066
• Status: Completed
• Start date: October 24, 2018
• Est. completion date: November 6, 2022

Study information

• Verified date: November 2022
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 6, 2022
• Est. primary completion date: February 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Embolism
• Embolism
• Intracranial Embolism

Intervention

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

Locations

Country	Name	City	State
Switzerland	Department of Anesthesiology and Pain Medicine	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quantity of cerebral microemboli load	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
Secondary	Cerebral hemispheric differences (left vs. right)		intraoperative phase, expected to be approx. 4 hours