Clinical trial NCT02341534: BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction
Official title: BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Myocardial Infarction, Acute
Myocardial Infarction Old
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
Collaborators: name: IHF GmbH - Institut für Herzinfarktforschung
name: Qmed Consulting A/S
First posted: 2015-01-19
Enrollment: 802
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The BIO\|GUARD-MI study investigates whether continuous arrhythmia monitoring and the consequent treatment after detected arrhythmias in patients after myocardial infarction with preserved cardiac function, but other risk factors, decreases the risk of major adverse cardiac events.

Detailed description: Patients randomized to the BioMonitor arm will receive an implantable cardiac monitor (ICM; BioMonitor) with remote monitoring function (Home Monitoring®). If the device detects and reports an arrhythmia, patients will be appropriately examined and treated. Patients randomized to the control arm will receive best proven treatment, but no implantable cardiac monitor.

Eligibility criteria: Inclusion Criteria:

* Patient has a history of MI according to guidelines
* 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:

* Patients with hemorrhagic diathesis
* 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

Primary outcomes:
measure: Kaplan-Meier Estimate of Percentage of Participants With Major Adverse Cardiac Event (MACE)
timeFrame: 2 years
Secondary outcomes:
measure: Kaplan-Meier Estimate of Percentage of Participants With Outcome of Death Due to Any Cause
timeFrame: 2 years
measure: Kaplan-Meier Estimate of Percentage of Participants With Outcome of Death Due to Any Cause or Heart Transplantation
timeFrame: 2 years
measure: Kaplan-Meier Estimate of Percentage of Participants With Outcome of Cardiovascular Death or Heart Transplantation
timeFrame: 2 years
measure: Kaplan-Meier Estimate of Percentage of Participants With Worsening of Heart Failure Requiring Hospitalization or Urgent Visit
timeFrame: 2 years
measure: Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia Resulting in Hospitalization
timeFrame: 2 years
measure: Kaplan-Meier Estimate of Percentage of Participants With Acute Coronary Syndrome Resulting in Hospitalization
timeFrame: 2 years
measure: Kaplan-Meier Estimate of Percentage of Participants With Stroke Resulting in Hospitalization
timeFrame: 2 years
measure: Kaplan-Meier Estimate of Percentage of Participants With Major Bleeding Resulting in Hospitalization
timeFrame: 2 years
measure: Kaplan-Meier Estimate of Percentage of Participants With Systemic Embolism Resulting in Hospitalization
timeFrame: 2 years
measure: Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia
timeFrame: 2 years
measure: Type of Initiated Therapies
timeFrame: All data are collected for the period from randomization until official study end or drop-out, for all enrolled patients, up to 6 years.
measure: Kaplan-Meier Estimate of Percentage of Participants Receiving Therapy After Arrhythmia Diagnosis
timeFrame: 2 years
measure: Change in World Health Organization Five Well-being Index (WHO-5) From 6 Months to 24 Months.
timeFrame: We report the intraindividual change from 6-months to 24-months. All data are collected for the period from randomization until official study end or drop-out, for all enrolled patients.
Other outcomes:
measure: Mean Value of EQ-5D-5L
timeFrame: From Baseline measurement to 60 months. All data are collected for the period from randomization until official study end or drop-out, for all enrolled patients.
Locations:
city: Saint Louis
country: United States
facility: Gateway Cardiology
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Heart and Vascular
state: Missouri
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Grand Forks
country: United States
facility: Altru Health System
state: North Dakota
city: Abington
country: United States
facility: Abington Medical Specialists
state: Pennsylvania
city: Lancaster
country: United States
facility: Carolina Heart Specialists
state: South Carolina
city: Rock Hill
country: United States
facility: Carolina Cardiology Associates
state: South Carolina
city: Knoxville
country: United States
facility: Metro Knoxville HMA LLC
state: Tennessee
city: Elizabeth Vale
country: Australia
facility: Lyell McEwin Hospital (LMH)
state: South Australia
city: Perth
country: Australia
facility: East Metropolitan Health Service Trading AS Royal Perth HOSPITAL
state: Western Australia
city: Canberra
country: Australia
facility: The Canberra Hospital
city: Linz
country: Austria
facility: Kepler Universitätsklinikum
state: Oberösterreich
city: Aalst
country: Belgium
facility: OLV Ziekenhuis Aalst
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg Genk (ZOL Genk)
city: Olomouc
country: Czechia
facility: Fakultní nemocnice Olomouc
city: Praha
country: Czechia
facility: Institute for Clinical and Experimental Medicine (IKEM)
city: České Budějovice
country: Czechia
facility: Nemocnice České Budějovice
city: Odense
country: Denmark
facility: Odense University Hospital (OUH)
state: Syddanmark
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospitel
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Herning
country: Denmark
facility: Regionshospitalet Herning
city: Roskilde
country: Denmark
facility: Sjaellands Universitets Hospital, Roskilde
city: Viborg
country: Denmark
facility: Regionshospitalet Viborg
city: Århus N
country: Denmark
facility: Århus Universitetshospital
city: Chambray-lès-Tours
country: France
facility: CHRU de Tours - Hôpital Trousseau
city: Clermont-Ferrand
country: France
facility: Hôpital Gabriel Montpied, Clermont Ferrand
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Bad Neustadt a.d. Saale
country: Germany
facility: Herz- und Gefäß- Klinik GmbH Bad Neustadt
city: Berlin
country: Germany
facility: Charité Universitätsklinikum - Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Vivantes Humboldt-Klinikum
city: Berlin
country: Germany
facility: Vivantes-Krankenhaus Spandau
city: Bielefeld
country: Germany
facility: Städtisches Krankenhaus Bielefeld-Mitte
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Fürth
country: Germany
facility: Klinikum Fürth
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera GmbH
city: Greifswald
country: Germany
facility: Ernst-Moritz-Arndt-Universität Greifswald
city: Jena
country: Germany
facility: Klinikum der Universität Jena
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein (UKSH) - Campus Lübeck
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Balatonfüred
country: Hungary
facility: National Hospital of Cardiology
city: Budapest
country: Hungary
facility: Gottsegen György
city: Budapest
country: Hungary
facility: Semmelweis Medical University
city: Budapest
country: Hungary
facility: Hungarian Defence Forces Military Hospital
city: Debrecen
country: Hungary
facility: The Debrecen University of Medicine
city: Pécs
country: Hungary
facility: The University of Pécs
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis Amsterdam (OLVG)
city: Emmen
country: Netherlands
facility: Scheperziekenhuis, Treant Zorggroep
city: Warszawa
country: Poland
facility: Klinika i Katedra Chorób Wewn. i Kardiologii
city: Warszawa
country: Poland
facility: National Institute of Cardiology
city: Banska Bystrica
country: Slovakia
facility: SÚSCCH
city: Košice
country: Slovakia
facility: East-Slovak Cardiology Institute (VUSCH)
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Madrid
country: Spain
facility: Hospital de la Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
Study officials:
affiliation: Rigshospitalet; Denmark; Copenhagen
name: Christian Jons, Doctor
role: STUDY_CHAIR
affiliation: Vivantes Humboldt Klinikum, Germany, Berlin
name: Steffen Behrens, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalborg University Hospital, Denmark, Aalborg
name: Poul Erik Bloch Thomsen, Professor
role: STUDY_DIRECTOR
affiliation: Aalborg University Hospital, Denmark, Aalborg
name: Peter Sogaard, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.