Mitral Valve InsufficiencyTCD-REDUCENCT04384198
TransCranial Doppler for REDUCtion of Silent strokE During MitraClip Implantation
A study testing Sonolysis in people with Mitral Valve Insufficiency, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The primary goal of the TCD-REDUCE study is to demonstrate the effectiveness of continuous transcranial Doppler sonography ("sonolysis") on the reduction of the ischemic stroke volume during MitraClip implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Insufficiency
- What is being tested?
- Sonolysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 13 Aug 2020to Dec 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with mitral regurgitation that are assigned to the MitraClip implantation by an interdisciplinary heart team according to current guidelines.
Who cannot join
- contraindication to MRI examination (e.g. pace-maker, implanted metal material, claustrophobia)
- pregnancy
- unable to consent
- no transtemporal window
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité-Campus Benjamin Franklin
Berlin, 12200
Tim Bastian Braemswig, MD
Christian H Nolte, Prof.
About this study
The primary goal of the TCD-REDUCE study is to demonstrate the effectiveness of continuous transcranial Doppler sonography ("sonolysis") on the reduction of the ischemic stroke volume during MitraClip implantation.
Read the detailed description
Cardiac procedures are associated with new cerebral ischemic lesions detected on diffusion-weighted MRI (Bendszus et al., 2006).
A previous study suggests that sonolysis (continuous transcranial Doppler sonography using a 2-MHz diagnostic probe) can reduce the risk of new cerebral ischemic lesions during carotid endarterectomy and carotid angioplasty / stenting (Skoloudik et al., 2015).
Currently, it is unknown whether sonolysis can also reduce the risk of new cerebral ischemic lesions during MitraClip implantation - a percutaneous treatment option in patients with moderate / severe mitral regurgitation.
In this study, patients will receive cerebral MRI and clinical neurological / neuropsychological examination before and after MitraClip implantation. During MitraClip implantation, all patients will receive continuous transcranial Doppler sonography using a 2-MHz diagnostic probe with maximal diagnostic energy administered through either the left or the right transtemporal window (computer-generated 1:1 randomization).
The primary endpoint is the median ischemic lesion volume detected on diffusion-weighted MRI after MitraClip implantation in the sonolysis group and in the control group.
- Conditions
- Mitral Valve Insufficiency
- Being tested
- Sonolysis
- Keywords
- MitraClip, Sonolysis, Stroke
- Medical subject headings
- Mitral Valve Insufficiency, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonolysisProcedure or surgery
Continuous transcranial Doppler sonography (TCD) using a 2-MHz diagnostic probe with maximal diagnostic energy
| Study group | Role | What they receive |
|---|---|---|
| Sonolysis group | Experimental | Cerebral hemisphere with sonolysis during MitraClip implantation. Receives: Procedure: Sonolysis |
| Control group | No intervention | Cerebral hemisphere without sonolysis during MitraClip implantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
stroke volume
median volume (in ml) of new ischemic lesions detected on diffusion-weighted MRI after MitraClip implantation in the sonolysis and in the control group
Measured: 0-5 days after the MitraClip Implantation
Secondary outcomes (10)
diffusion-weighted MRI lesions
new ischemic lesions (occurrence, number and location) detected on diffusion-weighted MRI after MitraClip implantation
Measured: 0-5 days after the MitraClip Implantation
intracerebral hemorrhage (ICH) and / or subarachnoid hemorrhage (SAH)
new ICH and / or SAH detected on T2*-weighted MRI after MitraClip implantation
Measured: 0-5 days after the MitraClip Implantation
cerebral microbleeds (CMB)
new cerebral microbleeds detected on T2*-weighted MRI after MitraClip implantation (occurrence, number and location)
Measured: 0-5 days after the MitraClip Implantation
clinically overt stroke
new clinically overt stroke (ischemic or hemorrhagic) or transient ischemic attack (TIA) after MitraClip implantation
Measured: (1) 0-5 days after the MitraClip Implantation and (2) 3 months after MitraClip implantation
functional outcome
functional outcome will be evaluated using the modified Rankin scale (mRS). The mRS ranges from 0 to 6 with 0 indicating no functional deficit (best score) and 6 indicating deaths (worst score).
Measured: (1) 0-5 days after the MitraClip Implantation and (2) 3 months after MitraClip implantation
cognitive outcome during hospital stay
cognitive outcome will be evaluated using the Montreal Cognitive Assessment (MoCA)
Measured: 0-5 days after the MitraClip Implantation
cognitive outcome at follow-up
cognitive outcome will be evaluated using the Telephone Interview for Cognitive Status (TICS)
Measured: 3 months after MitraClip implantation
delirium
delirium will be evaluated using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)
Measured: 0-5 days after the MitraClip Implantation
length of hospital stay (duration of hospitalization for the MitraClip implantation)
days of hospital stay from admission to hospital to discharge from hospital including direction of discharge (home, another hospital)
Measured: length of hospital stay (up to 3 months after MitraClip implantation)
mortality
mortality
Measured: up to 3 months after MitraClip implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start13 Aug 2020
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- PROBE
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Berlin Institute of Health
- Responsible party
- Principal investigator, Christian Nolte, Charite University, Berlin, Germany
- Investigators
- Christian H Nolte, Prof., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384198
- Sponsor's protocol ID
- EA4/193/19
- Acronym
- TCD-REDUCE
- Status last verified
- Sep 2023
- First submitted
- 30 Apr 2020
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Skoloudik D, Kuliha M, Hrbac T, Jonszta T, Herzig R; SONOBUSTER Trial Group. Sonolysis in Prevention of Brain Infarction During Carotid Endarterectomy and Stenting (SONOBUSTER): a randomized, controlled trial. Eur Heart J. 2016 Oct 21;37(40):3096-3102. doi: 10.1093/eurheartj/ehv492. Epub 2015 Sep 28.
PubMed 26417059
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TransCranial Doppler for REDUCtion of Silent strokE During MitraClip Implantation
- ClinicalTrials.gov ID
- NCT04384198
- Acronym / sponsor ID
- TCD-REDUCE / EA4/193/19
- Conditions
- Mitral Valve Insufficiency
- Keywords
- MitraClip, Sonolysis, Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Berlin Institute of Health
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 May 2020 (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.
The primary goal of the TCD-REDUCE study is to demonstrate the effectiveness of continuous transcranial Doppler sonography ("sonolysis") on the reduction of the ischemic stroke volume during MitraClip implantation.
Detailed description
Cardiac procedures are associated with new cerebral ischemic lesions detected on diffusion-weighted MRI (Bendszus et al., 2006).
A previous study suggests that sonolysis (continuous transcranial Doppler sonography using a 2-MHz diagnostic probe) can reduce the risk of new cerebral ischemic lesions during carotid endarterectomy and carotid angioplasty / stenting (Skoloudik et al., 2015).
Currently, it is unknown whether sonolysis can also reduce the risk of new cerebral ischemic lesions during MitraClip implantation - a percutaneous treatment option in patients with moderate / severe mitral regurgitation.
In this study, patients will receive cerebral MRI and clinical neurological / neuropsychological examination before and after MitraClip implantation. During MitraClip implantation, all patients will receive continuous transcranial Doppler sonography using a 2-MHz diagnostic probe with maximal diagnostic energy administered through either the left or the right transtemporal window (computer-generated 1:1 randomization).
The primary endpoint is the median ischemic lesion volume detected on diffusion-weighted MRI after MitraClip implantation in the sonolysis group and in the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- PROBE
| Arm | Type | Receives |
|---|---|---|
| Sonolysis group | Experimental | Procedure: SonolysisCerebral hemisphere with sonolysis during MitraClip implantation. |
| Control group | No intervention | –Cerebral hemisphere without sonolysis during MitraClip implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with mitral regurgitation that are assigned to the MitraClip implantation by an interdisciplinary heart team according to current guidelines.
Key exclusion criteria (4 listed)
- contraindication to MRI examination (e.g. pace-maker, implanted metal material, claustrophobia)
- pregnancy
- unable to consent
- no transtemporal 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 |
|---|---|---|
| SonolysisContinuous transcranial Doppler sonography (TCD) using a 2-MHz diagnostic probe with maximal diagnostic energy | Procedure or surgery | Sonolysis group |
Primary outcome
stroke volume
Time frame: 0-5 days after the MitraClip Implantation
median volume (in ml) of new ischemic lesions detected on diffusion-weighted MRI after MitraClip implantation in the sonolysis and in the control group
10 secondary outcomes
diffusion-weighted MRI lesions
Time frame: 0-5 days after the MitraClip Implantation
intracerebral hemorrhage (ICH) and / or subarachnoid hemorrhage (SAH)
Time frame: 0-5 days after the MitraClip Implantation
cerebral microbleeds (CMB)
Time frame: 0-5 days after the MitraClip Implantation
clinically overt stroke
Time frame: (1) 0-5 days after the MitraClip Implantation and (2) 3 months after MitraClip implantation
functional outcome
Time frame: (1) 0-5 days after the MitraClip Implantation and (2) 3 months after MitraClip implantation
cognitive outcome during hospital stay
Time frame: 0-5 days after the MitraClip Implantation
cognitive outcome at follow-up
Time frame: 3 months after MitraClip implantation
delirium
Time frame: 0-5 days after the MitraClip Implantation
length of hospital stay (duration of hospitalization for the MitraClip implantation)
Time frame: length of hospital stay (up to 3 months after MitraClip implantation)
mortality
Time frame: up to 3 months after MitraClip implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Background: PubMed 26417059Skoloudik D, Kuliha M, Hrbac T, Jonszta T, Herzig R; SONOBUSTER Trial Group. Sonolysis in Prevention of Brain Infarction During Carotid Endarterectomy and Stenting (SONOBUSTER): a randomized, controlled trial. Eur Heart J. 2016 Oct 21;37(40):3096-3102. doi: 10.1093/eurheartj/ehv492. Epub 2015 Sep 28.
- 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.
Christian H Nolte, Prof. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonolysis in people with Mitral Valve Insufficiency, run by Charite University, Berlin, Germany at 1 site in Germany.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Sep 2023. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tim Bastian Braemswig, MD (+49 30 450560624, tim-bastian.braemswig@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stroke volume (time frame: 0-5 days after the MitraClip Implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04384198, which also lists 1 linked publication.
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 6 Sep 2023.