BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction (BIO-GUARD-MI)

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Myocardial Infarction Old; Myocardial Infarction, Acute
• Intervention / Treatment: Device: BioMonitor

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.

• Study Type: Interventional
• Enrollment (Actual): 802
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Canberra, Australia, 2605
    • The Canberra Hospital
  • South Australia
    • Elizabeth Vale, South Australia, Australia, 5112
      • Lyell McEwin Hospital (LMH)
  • Western Australia
    • Perth, Western Australia, Australia, 6000
      • East Metropolitan Health Service Trading AS Royal Perth HOSPITAL
• Austria
  • Oberösterreich
    • Linz, Oberösterreich, Austria, 4020
      • Kepler Universitätsklinikum
• Belgium
  • Aalst, Belgium, 9300
    • OLV Ziekenhuis Aalst
  • Genk, Belgium, 3600
    • Ziekenhuis Oost Limburg Genk (ZOL Genk)
• Czechia
  • Olomouc, Czechia, 77900
    • Fakultni nemocnice Olomouc
  • Praha, Czechia, 14021
    • Institute for Clinical and Experimental Medicine (IKEM)
  • České Budějovice, Czechia, 37001
    • Nemocnice Ceske Budejovice
• Denmark
  • Aalborg, Denmark, 9100
    • Aalborg Universitetshospitel
  • Copenhagen, Denmark, 2100
    • Rigshospitalet
  • Herning, Denmark, 7400
    • Regionshospitalet Herning
  • Roskilde, Denmark, 4000
    • Sjaellands Universitets Hospital, Roskilde
  • Viborg, Denmark, 8800
    • Regionshospitalet Viborg
  • Århus N, Denmark, 8200-DK
    • Århus Universitetshospital
  • Syddanmark
    • Odense, Syddanmark, Denmark, 5000
      • Odense University Hospital (OUH)
• France
  • Chambray-lès-Tours, France, 37170
    • CHRU de Tours - Hopital Trousseau
  • Clermont-Ferrand, France, BP69-63003
    • Hôpital Gabriel Montpied, Clermont Ferrand
• Germany
  • Bad Berka, Germany, 99437
    • Zentralklinik Bad Berka GmbH
  • Bad Neustadt a.d. Saale, Germany, 97616
    • Herz- und Gefäß- Klinik GmbH Bad Neustadt
  • Berlin, Germany, 13509
    • Vivantes Humboldt-Klinikum
  • Berlin, Germany, 12200
    • Charité Universitätsklinikum - Campus Benjamin Franklin
  • Berlin, Germany, 13585
    • Vivantes-Krankenhaus Spandau
  • Bielefeld, Germany, 33604
    • Städtisches Krankenhaus Bielefeld-Mitte
  • Coburg, Germany, 96450
    • Klinikum Coburg
  • Fürth, Germany, 90766
    • Klinikum Fürth
  • Gera, Germany, 07548
    • SRH Wald-Klinikum Gera GmbH
  • Greifswald, Germany, 17475
    • Ernst-Moritz-Arndt-Universität Greifswald
  • Jena, Germany, 7743
    • Klinikum der Universität Jena
  • Leipzig, Germany, 04289
    • Herzzentrum Leipzig GmbH
  • Lübeck, Germany, 23562
    • Universitätsklinikum Schleswig-Holstein (UKSH) - Campus Lübeck
  • Minden, Germany, 32429
    • Johannes Wesling Klinikum Minden
  • Villingen-Schwenningen, Germany, 78052
    • Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
  • Würzburg, Germany, 97080
    • Universitätsklinikum Würzburg
• Hungary
  • Balatonfüred, Hungary, 8231
    • National Hospital of Cardiology
  • Budapest, Hungary, 1096
    • Gottsegen György
  • Budapest, Hungary, 1122
    • Semmelweis Medical University
  • Budapest, Hungary, 1134
    • Hungarian Defence Forces Military Hospital
  • Debrecen, Hungary, 4032
    • The Debrecen University of Medicine
  • Pécs, Hungary, H-7624
    • The University of Pécs
• Latvia
  • Riga, Latvia, 1002
    • Pauls Stradins Clinical University Hospital
  • Riga, Latvia, 1038
    • Riga East Clinical University Hospital
• Netherlands
  • Amsterdam, Netherlands, 1090
    • Onze Lieve Vrouwe Gasthuis Amsterdam (OLVG)
  • Emmen, Netherlands, 7824AA
    • Scheperziekenhuis, Treant Zorggroep
• Poland
  • Warszawa, Poland, 02 097
    • Klinika i Katedra Chorób Wewn. i Kardiologii
  • Warszawa, Poland, 02 097
    • National Institute of Cardiology
• Slovakia
  • Banska Bystrica, Slovakia, 974 01
    • SUSCCH
  • Košice, Slovakia, 040 11
    • East-Slovak Cardiology Institute (VUSCH)
• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Madrid, Spain, 28034
    • Hospital Universitario Ramón y Cajal
  • Madrid, Spain, 28006
    • Hospital de La Princesa
• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63136
      • St. Louis Heart and Vascular
    • Saint Louis, Missouri, United States, 63128
      • Gateway Cardiology
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • North Dakota
    • Grand Forks, North Dakota, United States, 58201
      • Altru Health System
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Medical Specialists
  • South Carolina
    • Lancaster, South Carolina, United States, 29720
      • Carolina Heart Specialists
    • Rock Hill, South Carolina, United States, 29732
      • Carolina Cardiology Associates
  • Tennessee
    • Knoxville, Tennessee, United States, 37934
      • Metro Knoxville HMA LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: BioMonitor arm; BioMonitor group (implantation with investigational device + transfer of information via Home Monitoring)	Device: BioMonitor; Patients will be implanted with the BioMonitor + Home Monitoring feature
No Intervention: Control arm; Control group (standard of care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kaplan-Meier Estimate of Percentage of Participants With Major Adverse Cardiac Event (MACE)	The primary endpoint is defined as death for cardiovascular reasons or unplanned hospitalization for cardiovascular reasons as per study protocol. The time period with regards to the Time-to-Event Outcome Measures starts with the randomization of the patient. All patients will be assessed for Time-to-Event Outcome Measures until formal study termination is announced or until the individual patient meets a drop out criterion in accordance with the study protocol. The study period is estimated 6 years.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kaplan-Meier Estimate of Percentage of Participants With Outcome of Death Due to Any Cause	The occurrence of death due to any cause will be recorded and analyzed.	2 years
Kaplan-Meier Estimate of Percentage of Participants With Outcome of Death Due to Any Cause or Heart Transplantation	Assessment of the time from randomization to death for any reason or heart transplantation during the clinical investigation.	2 years
Kaplan-Meier Estimate of Percentage of Participants With Outcome of Cardiovascular Death or Heart Transplantation	Assessment of the time from randomization to cardiovascular death or heart transplantation during the clinical investigation. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement.	2 years
Kaplan-Meier Estimate of Percentage of Participants With Worsening of Heart Failure Requiring Hospitalization or Urgent Visit	Assessment of the time from randomization to first hospitalization or urgent visit for worsening of the patient status due to heart failure, or death due to heart failure. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement.	2 years
Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia Resulting in Hospitalization	Assessment of the time from randomization to the first hospitalization resulting from an arrhythmia or death resulting from arrhythmia. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement.	2 years
Kaplan-Meier Estimate of Percentage of Participants With Acute Coronary Syndrome Resulting in Hospitalization	Assessment of the time from randomization to the first hospitalization resulting from acute coronary syndrome or death resulting from acute coronary syndrome. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement.	2 years
Kaplan-Meier Estimate of Percentage of Participants With Stroke Resulting in Hospitalization	Assessment of the time from randomization to the first hospitalization resulting from stroke or death resulting from stroke. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement.	2 years
Kaplan-Meier Estimate of Percentage of Participants With Major Bleeding Resulting in Hospitalization	Assessment of the time from randomization to the first hospitalization resulting from major bleeding or death resulting from major bleeding. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement.	2 years
Kaplan-Meier Estimate of Percentage of Participants With Systemic Embolism Resulting in Hospitalization	Assessment of the time from randomization to the first hospitalization resulting from systemic embolism or death resulting from systemic embolism. A specified endpoint definition will be given by the members of the EAEC and documented in the charter agreement.	2 years
Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia	Assessment of the time from randomization to first arrhythmia.	2 years
Type of Initiated Therapies	Post-hoc categorical summary of most frequent therapies initiated after detection of arrhythmias.	All data are collected for the period from randomization until official study end or drop-out, for all enrolled patients, up to 6 years.
Kaplan-Meier Estimate of Percentage of Participants Receiving Therapy After Arrhythmia Diagnosis	Assessment of the time from randomization to first therapy. In this context therapy is the attempted remediation of the patient's regular heartbeat.	2 years
Change in World Health Organization Five Well-being Index (WHO-5) From 6 Months to 24 Months.	A further secondary endpoint is the assessment of the patient's well-being. The patient's well-being will be recorded during the regular telephone contacts using the WHO-5 Well-being Index. The scale reaches from 0 (worst status) to 100 (best possible status).	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Value of EQ-5D-5L	The EQ-5D-5L questionnaire was administered during the telephone contacts to estimate utility values at different time points for an economic evaluation. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The scale reaches from 0 (worst status) to 100 (best possible status).	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.

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG
• Collaborators: IHF GmbH - Institut für Herzinfarktforschung; Qmed Consulting A/S
• Investigators: Study Chair: Christian Jons, Doctor, Rigshospitalet; Denmark; Copenhagen; Principal Investigator: Steffen Behrens, Professor, Vivantes Humboldt Klinikum, Germany, Berlin; Study Director: Poul Erik Bloch Thomsen, Professor, Aalborg University Hospital, Denmark, Aalborg; Principal Investigator: Peter Sogaard, Professor, Aalborg University Hospital, Denmark, Aalborg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2015
• Primary Completion (Actual): November 3, 2021
• Study Completion (Actual): November 3, 2021

Study Registration Dates

• First Submitted: December 12, 2014
• First Submitted That Met QC Criteria: January 14, 2015
• First Posted (Estimate): January 19, 2015

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: HS058; Preserved Ejection Fraction (Other Identifier: BIOTRONIK); Implantable Cardiac Device (Other Identifier: BIOTRONIK); Loop Recorder (Other Identifier: BIOTRONIK); ICM (Other Identifier: BIOTRONIK)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes