TransCranial Doppler for REDUCtion of Silent strokE During MitraClip Implantation

Not Applicable

Recruiting

• Conditions: Mitral Valve Insufficiency
• Interventions: Procedure: Sonolysis

• Registration Number: NCT04384198
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study First Submitted: 2020-04-30
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-12
• Study Start: 2020-08-13
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-06
• Primary Completion: 2024-09
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sonolysis group	Sonolysis	Cerebral hemisphere with sonolysis during MitraClip implantation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
cognitive outcome during hospital stay	0-5 days after the MitraClip Implantation	cognitive outcome will be evaluated using the Montreal Cognitive Assessment (MoCA)
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
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
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
cognitive outcome at follow-up	3 months after MitraClip implantation	cognitive outcome will be evaluated using the Telephone Interview for Cognitive Status (TICS)
delirium	0-5 days after the MitraClip Implantation	delirium will be evaluated using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)
mortality	up to 3 months after MitraClip implantation	mortality
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)
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)

Trial Locations

Locations (1)

Charité-Campus Benjamin Franklin; 🇩🇪 Berlin, Germany