TransCranial Doppler for REDUCtion of Silent strokE During MitraClip Implantation

Mitral Valve Insufficiency Clinical Trial

— TCD-REDUCE  

Official title:

TransCranial Doppler for REDUCtion of Silent strokE During MitraClip Implantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04384198
• Other study ID #: EA4/193/19
• Status: Recruiting
• Phase: N/A
• Start date: August 13, 2020
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Charite University, Berlin, Germany
• Contact: Tim Bastian Braemswig, MD
• Phone: +49 30 450560624
• Email: tim-bastian.braemswig[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Valve Insufficiency

Intervention

Procedure:
• Sonolysis
Continuous transcranial Doppler sonography (TCD) using a 2-MHz diagnostic probe with maximal diagnostic energy

Locations

Country	Name	City	State
Germany	Charité-Campus Benjamin Franklin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Berlin Institute of Health

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	0-5 days after the MitraClip Implantation
Secondary	diffusion-weighted MRI lesions	new ischemic lesions (occurrence, number and location) detected on diffusion-weighted MRI after MitraClip implantation	0-5 days after the MitraClip Implantation
Secondary	intracerebral hemorrhage (ICH) and / or subarachnoid hemorrhage (SAH)	new ICH and / or SAH detected on T2*-weighted MRI after MitraClip implantation	0-5 days after the MitraClip Implantation
Secondary	cerebral microbleeds (CMB)	new cerebral microbleeds detected on T2*-weighted MRI after MitraClip implantation (occurrence, number and location)	0-5 days after the MitraClip Implantation
Secondary	clinically overt stroke	new clinically overt stroke (ischemic or hemorrhagic) or transient ischemic attack (TIA) after MitraClip implantation	(1) 0-5 days after the MitraClip Implantation and (2) 3 months after MitraClip implantation
Secondary	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).	(1) 0-5 days after the MitraClip Implantation and (2) 3 months after MitraClip implantation
Secondary	cognitive outcome during hospital stay	cognitive outcome will be evaluated using the Montreal Cognitive Assessment (MoCA)	0-5 days after the MitraClip Implantation
Secondary	cognitive outcome at follow-up	cognitive outcome will be evaluated using the Telephone Interview for Cognitive Status (TICS)	3 months after MitraClip implantation
Secondary	delirium	delirium will be evaluated using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)	0-5 days after the MitraClip Implantation
Secondary	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)	length of hospital stay (up to 3 months after MitraClip implantation)
Secondary	mortality	mortality	up to 3 months after MitraClip implantation