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Silent sTROke duriNG MitraClip Implantation (STRONG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03104556
Recruitment Status : Unknown
Verified April 2017 by Alexander Lauten, Charite University, Berlin, Germany.
Recruitment status was:  Not yet recruiting
First Posted : April 7, 2017
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Alexander Lauten, Charite University, Berlin, Germany

Brief Summary:
The MitraClip-procedure offers an interventional treatment for high risk patients with severe symptomatic mitral regurgitation. The number of new cerebral ischemic lesions without clinical manifestations is high. The aim of this study is to determine the frequency of cerebral embolisms and cerebral lesions during the MitraClip-procedure using transcranial doppler ultrasound and magnetic resonance imaging.

Condition or disease
Mitral Regurgitation Silent Stroke

Detailed Description:
Mitral regurgitation is the second most common manifestation of valvular heart disease in adults. Surgical reconstruction is considered treatment of choice. For some patients the surgical risk is to high an operation is refused. For those Patients the MitraClip system (Abbott Vascular, Menlo Park, CA, USA) offers a much less invasive treatment option. Occurrence of a stroke or transient ischemic attack (TIA) is one of the potential complications during this procedure. 1% of all patients have an acute stroke. The number of new ischemic lesions without clinical manifestations is much higher (up to 85%). The impact of these lesions on the global cognitive function is unclear. The aim of this study is to determine the frequency of cerebral embolisms related to predefined procedural intervals and postprocedural cerebral lesions using Transcranial Doppler ultrasound and magnetic resonance imaging. Furthermore we want to study the correlation between cerebral embolisms seen as high intensity signals in transcranial duplex ultrasound and cerebral lesions seen in the cMRT. The results should build a basis for further studies that want to reduce the amount of cerebral lesions.

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Silent sTROke duriNG MitraClip Implantation - STRONG-MitraClip
Estimated Study Start Date : April 14, 2017
Estimated Primary Completion Date : December 31, 2019



Primary Outcome Measures :
  1. Total amount of high intensity signals (HITS) during the predefined procedural intervals [ Time Frame: during the procedure ]

Secondary Outcome Measures :
  1. Total amount of high intensity signals and cerebral lesions related to primary and secondary mitral regurgitation [ Time Frame: 0-72h ]
  2. Localizations of cerebral lesions after MitraClip-procedure [ Time Frame: 0-72h ]
  3. Incidence of peri- and postprocedural stroke [ Time Frame: 0-72h ]
  4. Incidence of delirium after MitraClip [ Time Frame: 0-72h ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients undergoing the MitraClip between April 2017 December 2019 procedure due to a severe mitral regurgitation will be enrolled in our study. All patients will be assigned to either a surgical procedure or the MitraClip-procedure by an interdisciplinary heart team according to current guidelines irrespective of this study.
Criteria

Inclusion Criteria:

Patients undergoing a MitraClip-procedure due to mitral regurgitation in the study period Written consent Procedure recommended by a Cardio-Thoracic Surgery Conference

Exclusion Criteria:

Patients who are not able to give consent Patients <18 years Participation in another interventional Trial Pregnant or lactating females Contraindication to MRI


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104556


Contacts
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Contact: Alexander Lauten, Prof. Dr. 00493045050 alexander.lauten@charite.de

Sponsors and Collaborators
Charite University, Berlin, Germany
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Responsible Party: Alexander Lauten, Prof. Dr. med. A. Lauten, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03104556    
Other Study ID Numbers: STRONG-MitraClip 01
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Mitral Valve Insufficiency
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Valve Diseases
Heart Diseases