Mitral Valve Insufficiency
Conditions
Keywords
MitraClip, Sonolysis, Stroke
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.
Interventions
PROCEDURESonolysis
Continuous transcranial Doppler sonography (TCD) using a 2-MHz diagnostic probe with maximal diagnostic energy
Sponsors
Berlin Institute of Health
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
PROBE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| stroke volume | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intracerebral hemorrhage (ICH) and / or subarachnoid hemorrhage (SAH) | 0-5 days after the MitraClip Implantation | new ICH and / or SAH detected on T2\*-weighted MRI after MitraClip implantation |
| cerebral microbleeds (CMB) | 0-5 days after the MitraClip Implantation | new cerebral microbleeds detected on T2\*-weighted MRI after MitraClip implantation (occurrence, number and location) |
| clinically overt stroke | (1) 0-5 days after the MitraClip Implantation and (2) 3 months after MitraClip implantation | new clinically overt stroke (ischemic or hemorrhagic) or transient ischemic attack (TIA) after MitraClip implantation |
| functional outcome | (1) 0-5 days after the MitraClip Implantation and (2) 3 months after MitraClip implantation | 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). |
| diffusion-weighted MRI lesions | 0-5 days after the MitraClip Implantation | new ischemic lesions (occurrence, number and location) detected on diffusion-weighted MRI after MitraClip implantation |
| cognitive outcome at follow-up | 3 months after MitraClip implantation | cognitive outcome will be evaluated using the Telephone Interview for Cognitive Status (TICS) |
| mortality | up to 3 months after MitraClip implantation | mortality |
| delirium | 0-5 days after the MitraClip Implantation | delirium will be evaluated using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) |
| length of hospital stay (duration of hospitalization for the MitraClip implantation) | length of hospital stay (up to 3 months after MitraClip implantation) | days of hospital stay from admission to hospital to discharge from hospital including direction of discharge (home, another hospital) |
| cognitive outcome during hospital stay | 0-5 days after the MitraClip Implantation | cognitive outcome will be evaluated using the Montreal Cognitive Assessment (MoCA) |
Countries
Germany
Contacts
Primary ContactTim Bastian Braemswig, MD
Outcome results
None listed