Cerebral EmbolismZEMEKNCT03802760
Cerebral Microembolism in Cardiology
An observational study of Cerebral Embolism, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cerebral Embolism
- What is being tested?
- Transcranial Doppler (TCD) ultrasound measurement
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Oct 2018to 6 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing Interventional cardiology procedure (TAVI, MitraClip, TricuspidalClip)
Who may be able to join
- Age > 18 years
- Interventional cardiology procedure (TAVI, MitraClip, TricuspidalClip)
Who cannot join
- Allergy to ultrasound gel or materials contained in the TCD probe
- Missing temporal bone window
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Anesthesiology and Pain Medicine
Bern, 3010
About this study
Official title: 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.
- Conditions
- Cerebral Embolism
- Being tested
- Transcranial Doppler (TCD) ultrasound measurement
- Medical subject headings
- Intracranial Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Doppler (TCD) ultrasound measurementDevice
Non-invasive measurement of cerebral embolic load and blood flow using TCD
| Study group | Role | What they receive |
|---|---|---|
| TAVI patients | Patients undergoing transfemoral TAVI Receives: Device: Transcranial Doppler (TCD) ultrasound measurement | |
| MitraClip patients | Patients undergoing MitraClip implantation Receives: Device: Transcranial Doppler (TCD) ultrasound measurement | |
| TricuspidalClip | Patients undergoing TricuspidalClip implantation Receives: Device: Transcranial Doppler (TCD) ultrasound measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: intraoperative phase, expected to be approx. 4 hours
Secondary outcomes (2)
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.
Measured: intraoperative phase, expected to be approx. 4 hours
Cerebral hemispheric differences (left vs. right)
Measured: intraoperative phase, expected to be approx. 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start24 Oct 2018
- Primary completion24 Feb 2022
- Study completion6 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral EmbolismStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabor Erdös, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802760
- Sponsor's protocol ID
- 2018-01066
- Other IDs
- 2018
- Acronym
- ZEMEK
- Status last verified
- Nov 2022
- First submitted
- 22 Oct 2018
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Microembolism in Interventional Cardiology Procedures
- ClinicalTrials.gov ID
- NCT03802760
- Acronym / sponsor ID
- ZEMEK / 2018-01066
- Conditions
- Cerebral Embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 24 Feb 2022 (actual)
- Study completion
- 6 Nov 2022 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAVI patients | – | Device: Transcranial Doppler (TCD) ultrasound measurementPatients undergoing transfemoral TAVI |
| MitraClip patients | – | Device: Transcranial Doppler (TCD) ultrasound measurementPatients undergoing MitraClip implantation |
| TricuspidalClip | – | Device: Transcranial Doppler (TCD) ultrasound measurementPatients undergoing TricuspidalClip implantation |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing Interventional cardiology procedure (TAVI, MitraClip, TricuspidalClip)
Key inclusion criteria (2 listed)
- Age > 18 years
- Interventional cardiology procedure (TAVI, MitraClip, TricuspidalClip)
Key exclusion criteria (2 listed)
- Allergy to ultrasound gel or materials contained in the TCD probe
- Missing temporal bone window
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Doppler (TCD) ultrasound measurementNon-invasive measurement of cerebral embolic load and blood flow using TCD | Device | MitraClip patients, TAVI patients, TricuspidalClip |
Primary outcome
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.
2 secondary outcomes
Quantity of cerebral microemboli load
Time frame: intraoperative phase, expected to be approx. 4 hours
Cerebral hemispheric differences (left vs. right)
Time frame: intraoperative phase, expected to be approx. 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Embolism, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of cerebral microemboli (solid vs. gaseous) (time frame: intraoperative phase, expected to be approx. 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.