BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction
NCT ID: NCT02341534
Last Updated: 2023-04-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
802 participants
INTERVENTIONAL
2015-08-07
2021-11-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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BioMonitor arm
BioMonitor group (implantation with investigational device + transfer of information via Home Monitoring)
BioMonitor
Patients will be implanted with the BioMonitor + Home Monitoring feature
Control arm
Control group (standard of care)
No interventions assigned to this group
Interventions
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BioMonitor
Patients will be implanted with the BioMonitor + Home Monitoring feature
Eligibility Criteria
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Inclusion Criteria
* CHA2DS2-VASc-Score ≥ 4 in men / ≥ 5 in women
* LVEF \> 35 % as estimated within 6 months before enrollment but after conclusion of AMI treatment
* Patient accepts activation of Home Monitoring®
* Patient is able to understand the nature of the clinical study and has provided written informed consent
Exclusion Criteria
* Permanent oral anticoagulation treatment for atrial fibrillation
* Indication for chronic renal dialysis
* Pacemaker or ICD implanted or indication for implantation
* Parkinson's disease
* Life expectancy \< 1 year
* Participation in another interventional clinical Investigation
* Age \< 18 years
* Woman who are pregnant or breast feeding
18 Years
99 Years
ALL
No
Sponsors
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IHF GmbH - Institut für Herzinfarktforschung
OTHER
Qmed Consulting A/S
INDUSTRY
Biotronik SE & Co. KG
INDUSTRY
Responsible Party
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Principal Investigators
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Christian Jons, Doctor
Role: STUDY_CHAIR
Rigshospitalet; Denmark; Copenhagen
Steffen Behrens, Professor
Role: PRINCIPAL_INVESTIGATOR
Vivantes Humboldt Klinikum, Germany, Berlin
Poul Erik Bloch Thomsen, Professor
Role: STUDY_DIRECTOR
Aalborg University Hospital, Denmark, Aalborg
Peter Sogaard, Professor
Role: PRINCIPAL_INVESTIGATOR
Aalborg University Hospital, Denmark, Aalborg
Locations
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Gateway Cardiology
St Louis, Missouri, United States
St. Louis Heart and Vascular
St Louis, Missouri, United States
University of Rochester Medical Center
Rochester, New York, United States
Altru Health System
Grand Forks, North Dakota, United States
Abington Medical Specialists
Abington, Pennsylvania, United States
Carolina Heart Specialists
Lancaster, South Carolina, United States
Carolina Cardiology Associates
Rock Hill, South Carolina, United States
Metro Knoxville HMA LLC
Knoxville, Tennessee, United States
Lyell McEwin Hospital (LMH)
Elizabeth Vale, South Australia, Australia
East Metropolitan Health Service Trading AS Royal Perth HOSPITAL
Perth, Western Australia, Australia
The Canberra Hospital
Canberra, , Australia
Kepler Universitätsklinikum
Linz, Upper Austria, Austria
OLV Ziekenhuis Aalst
Aalst, , Belgium
Ziekenhuis Oost Limburg Genk (ZOL Genk)
Genk, , Belgium
Nemocnice České Budějovice
České Budějovice, , Czechia
Fakultní nemocnice Olomouc
Olomouc, , Czechia
Institute for Clinical and Experimental Medicine (IKEM)
Prague, , Czechia
Odense University Hospital (OUH)
Odense, Region Syddanmark, Denmark
Aalborg Universitetshospitel
Aalborg, , Denmark
Århus Universitetshospital
Århus N, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Regionshospitalet Herning
Herning, , Denmark
Sjaellands Universitets Hospital, Roskilde
Roskilde, , Denmark
Regionshospitalet Viborg
Viborg, , Denmark
CHRU de Tours - Hôpital Trousseau
Chambray-lès-Tours, , France
Hôpital Gabriel Montpied, Clermont Ferrand
Clermont-Ferrand, , France
Zentralklinik Bad Berka GmbH
Bad Berka, , Germany
Herz- und Gefäß- Klinik GmbH Bad Neustadt
Bad Neustadt A.d. Saale, , Germany
Charité Universitätsklinikum - Campus Benjamin Franklin
Berlin, , Germany
Vivantes Humboldt-Klinikum
Berlin, , Germany
Vivantes-Krankenhaus Spandau
Berlin, , Germany
Städtisches Krankenhaus Bielefeld-Mitte
Bielefeld, , Germany
Klinikum Coburg
Coburg, , Germany
Klinikum Fürth
Fürth, , Germany
SRH Wald-Klinikum Gera GmbH
Gera, , Germany
Ernst-Moritz-Arndt-Universität Greifswald
Greifswald, , Germany
Klinikum der Universität Jena
Jena, , Germany
Herzzentrum Leipzig GmbH
Leipzig, , Germany
Universitätsklinikum Schleswig-Holstein (UKSH) - Campus Lübeck
Lübeck, , Germany
Johannes Wesling Klinikum Minden
Minden, , Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Villingen-Schwenningen, , Germany
Universitätsklinikum Würzburg
Würzburg, , Germany
National Hospital of Cardiology
Balatonfüred, , Hungary
Gottsegen György
Budapest, , Hungary
Semmelweis Medical University
Budapest, , Hungary
Hungarian Defence Forces Military Hospital
Budapest, , Hungary
The Debrecen University of Medicine
Debrecen, , Hungary
The University of Pécs
Pécs, , Hungary
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Riga East Clinical University Hospital
Riga, , Latvia
Onze Lieve Vrouwe Gasthuis Amsterdam (OLVG)
Amsterdam, , Netherlands
Scheperziekenhuis, Treant Zorggroep
Emmen, , Netherlands
Klinika i Katedra Chorób Wewn. i Kardiologii
Warsaw, , Poland
National Institute of Cardiology
Warsaw, , Poland
SÚSCCH
Banská Bystrica, , Slovakia
East-Slovak Cardiology Institute (VUSCH)
Košice, , Slovakia
Hospital del Mar
Barcelona, , Spain
Hospital de la Princesa
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Countries
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References
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Jons C, Bloch Thomsen PE, Riahi S, Smilde T, Bach U, Jacobsen PK, Taborsky M, Falukozy J, Wiemer M, Christensen PD, Konyi A, Schelfaut D, Bulava A, Grabowski M, Merkely B, Nuyens D, Mahajan R, Nagel P, Tilz R, Malczynski J, Steinwender C, Brachmann J, Serota H, Schrader J, Behrens S, Sogaard P. Arrhythmia monitoring and outcome after myocardial infarction (BIO|GUARD-MI): a randomized trial. Front Cardiovasc Med. 2024 May 13;11:1300074. doi: 10.3389/fcvm.2024.1300074. eCollection 2024.
Jons C, Sogaard P, Behrens S, Schrader J, Mrosk S, Bloch Thomsen PE. The clinical effect of arrhythmia monitoring after myocardial infarction (BIO-GUARD|MI):study protocol for a randomized controlled trial. Trials. 2019 Sep 11;20(1):563. doi: 10.1186/s13063-019-3644-5.
Provided Documents
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Document Type: Study Protocol: Study Protocol used in the USA
Document Type: Study Protocol: Modification to study protocol used in the USA
Document Type: Study Protocol: Study Protocol used outside the USA (OUS)
Document Type: Statistical Analysis Plan
Other Identifiers
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Preserved Ejection Fraction
Identifier Type: OTHER
Identifier Source: secondary_id
Implantable Cardiac Device
Identifier Type: OTHER
Identifier Source: secondary_id
Loop Recorder
Identifier Type: OTHER
Identifier Source: secondary_id
ICM
Identifier Type: OTHER
Identifier Source: secondary_id
HS058
Identifier Type: -
Identifier Source: org_study_id
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