Clinical trial NCT04384198: TransCranial Doppler for REDUCtion of Silent strokE During MitraClip Implantation
Official title: TransCranial Doppler for REDUCtion of Silent strokE During MitraClip Implantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Valve Insufficiency
Keywords: MitraClip
Sonolysis
Stroke
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Berlin Institute of Health
First posted: 2020-05-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: PROBE
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

Patients with mitral regurgitation that are assigned to the MitraClip implantation by an interdisciplinary heart team according to current guidelines.

Exclusion Criteria:

* contraindication to MRI examination (e.g. pace-maker, implanted metal material, claustrophobia)
* pregnancy
* unable to consent
* no transtemporal window

Primary outcomes:
measure: stroke volume
timeFrame: 0-5 days after the MitraClip Implantation
Secondary outcomes:
measure: diffusion-weighted MRI lesions
timeFrame: 0-5 days after the MitraClip Implantation
measure: intracerebral hemorrhage (ICH) and / or subarachnoid hemorrhage (SAH)
timeFrame: 0-5 days after the MitraClip Implantation
measure: cerebral microbleeds (CMB)
timeFrame: 0-5 days after the MitraClip Implantation
measure: clinically overt stroke
timeFrame: (1) 0-5 days after the MitraClip Implantation and (2) 3 months after MitraClip implantation
measure: functional outcome
timeFrame: (1) 0-5 days after the MitraClip Implantation and (2) 3 months after MitraClip implantation
measure: cognitive outcome during hospital stay
timeFrame: 0-5 days after the MitraClip Implantation
measure: cognitive outcome at follow-up
timeFrame: 3 months after MitraClip implantation
measure: delirium
timeFrame: 0-5 days after the MitraClip Implantation
measure: length of hospital stay (duration of hospitalization for the MitraClip implantation)
timeFrame: length of hospital stay (up to 3 months after MitraClip implantation)
measure: mortality
timeFrame: up to 3 months after MitraClip implantation
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité-Campus Benjamin Franklin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Christian H Nolte, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.