Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-01 @ 1:59 AM
Study NCT ID:
NCT03104556
Status:
COMPLETED
Last Update Posted:
2020-12-16
First Post:
2017-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Silent sTROke duriNG MitraClip Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-13', 'studyFirstSubmitDate': '2017-04-01', 'studyFirstSubmitQcDate': '2017-04-01', 'lastUpdatePostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total amount of high intensity signals (HITS) during the predefined procedural intervals', 'timeFrame': 'during the procedure'}], 'secondaryOutcomes': [{'measure': 'Total amount of high intensity signals and cerebral lesions related to primary and secondary mitral regurgitation', 'timeFrame': '0-72h'}, {'measure': 'Localizations of cerebral lesions after MitraClip-procedure', 'timeFrame': '0-72h'}, {'measure': 'Incidence of peri- and postprocedural stroke', 'timeFrame': '0-72h'}, {'measure': 'Incidence of delirium after MitraClip', 'timeFrame': '0-72h'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mitral Regurgitation', 'Silent Stroke']}, 'referencesModule': {'references': [{'pmid': '36734351', 'type': 'DERIVED', 'citation': 'Braemswig TB, Kusserow M, Bellmann B, Beckhoff F, Reinthaler M, von Rennenberg R, Erdur H, Scheitz JF, Galinovic I, Villringer K, Leistner DM, Audebert HJ, Endres M, Landmesser U, Haeusler KG, Fiebach JB, Lauten A, Rillig A, Nolte CH. New Cerebral Microbleeds After Catheter-Based Structural Heart Interventions: An Exploratory Analysis. J Am Heart Assoc. 2023 Feb 7;12(3):e8189. doi: 10.1161/JAHA.122.027284. Epub 2023 Feb 3.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients undergoing a MitraClip-procedure due to mitral regurgitation in the study period Written consent Procedure recommended by a Cardio-Thoracic Surgery Conference\n\nExclusion Criteria:\n\nPatients who are not able to give consent Patients \\<18 years Participation in another interventional Trial Pregnant or lactating females Contraindication to MRI'}, 'identificationModule': {'nctId': 'NCT03104556', 'acronym': 'STRONG', 'briefTitle': 'Silent sTROke duriNG MitraClip Implantation', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Silent sTROke duriNG MitraClip Implantation - STRONG-MitraClip', 'orgStudyIdInfo': {'id': 'STRONG-MitraClip 01'}}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Alexander Lauten, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Charite Kardiologie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. A. Lauten', 'investigatorFullName': 'Alexander Lauten', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}