Skip to main content
OpenTrials
Completed

NCT Number: NCT03802760

Cerebral Microembolism in Cardiology

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cerebral Embolism Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Intracranial Embolism Intracranial Embolism and Thrombosis Nervous System Diseases Thromboembolism Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Pain Medicine

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Doppler (TCD) ultrasound measurement

Device

Non-invasive measurement of cerebral embolic load and blood flow using TCD

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Cerebral Microembolism in Interventional Cardiology Procedures

Acronym: ZEMEK

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 14, 2019
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.