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Myocardial InfarctionBIO-GUARD-MINCT02341534

BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction

A study testing BioMonitor in people with Myocardial Infarction and Myocardial Infarction, Acute, run by Biotronik SE & Co. KG at 59 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
BioMonitor
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
802 participants
Where
59 sitesin 14 countries
Study dates
7 Aug 2015to 3 Nov 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Participation in another interventional clinical Investigation
  • Age < 18 years
  • Woman who are pregnant or breast feeding

Trial locations and contacts

59 sites in 14 countries.

59 sites in 14 countries

Germany16 sites

  • Zentralklinik Bad Berka GmbH

    Bad Berka, 99437

  • Herz- und Gefäß- Klinik GmbH Bad Neustadt

    Bad Neustadt A.d. Saale, 97616

  • Charité Universitätsklinikum - Campus Benjamin Franklin

    Berlin, 12200

  • Vivantes Humboldt-Klinikum

    Berlin, 13509

  • Vivantes-Krankenhaus Spandau

    Berlin, 13585

  • Städtisches Krankenhaus Bielefeld-Mitte

    Bielefeld, 33604

  • Klinikum Coburg

    Coburg, 96450

  • Klinikum Fürth

    Fürth, 90766

  • SRH Wald-Klinikum Gera GmbH

    Gera, 07548

  • Ernst-Moritz-Arndt-Universität Greifswald

    Greifswald, 17475

  • Klinikum der Universität Jena

    Jena, 7743

  • Herzzentrum Leipzig GmbH

    Leipzig, 04289

  • Universitätsklinikum Schleswig-Holstein (UKSH) - Campus Lübeck

    Lübeck, 23562

  • Johannes Wesling Klinikum Minden

    Minden, 32429

  • Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

    Villingen-Schwenningen, 78052

  • Universitätsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

United States8 sites

  • Abington Medical Specialists

    Abington, Pennsylvania, 19001

  • Altru Health System

    Grand Forks, North Dakota, 58201

  • Metro Knoxville HMA LLC

    Knoxville, Tennessee, 37934

  • Carolina Heart Specialists

    Lancaster, South Carolina, 29720

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Carolina Cardiology Associates

    Rock Hill, South Carolina, 29732

  • Gateway Cardiology

    St Louis, Missouri, 63128

  • St. Louis Heart and Vascular

    St Louis, Missouri, 63136

Other trials in United States

Denmark7 sites

  • Aalborg Universitetshospitel

    Aalborg, 9100

  • Århus Universitetshospital

    Århus N, 8200-DK

  • Rigshospitalet

    Copenhagen, 2100

  • Regionshospitalet Herning

    Herning, 7400

  • Odense University Hospital (OUH)

    Odense, Region Syddanmark, 5000

  • Sjaellands Universitets Hospital, Roskilde

    Roskilde, 4000

  • Regionshospitalet Viborg

    Viborg, 8800

Other trials in Denmark

Hungary6 sites

  • National Hospital of Cardiology

    Balatonfüred, 8231

  • Gottsegen György

    Budapest, 1096

  • Semmelweis Medical University

    Budapest, 1122

  • Hungarian Defence Forces Military Hospital

    Budapest, 1134

  • The Debrecen University of Medicine

    Debrecen, 4032

  • The University of Pécs

    Pécs, H-7624

Other trials in Hungary

Australia3 sites

  • The Canberra Hospital

    Canberra, 2605

  • Lyell McEwin Hospital (LMH)

    Elizabeth Vale, South Australia, 5112

  • East Metropolitan Health Service Trading AS Royal Perth HOSPITAL

    Perth, Western Australia, 6000

Other trials in Australia

Czechia3 sites

  • Nemocnice České Budějovice

    České Budějovice, 37001

  • Fakultní nemocnice Olomouc

    Olomouc, 77900

  • Institute for Clinical and Experimental Medicine (IKEM)

    Prague, 14021

Other trials in Czechia

Spain3 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital de la Princesa

    Madrid, 28006

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

Other trials in Spain

Belgium2 sites

  • OLV Ziekenhuis Aalst

    Aalst, 9300

  • Ziekenhuis Oost Limburg Genk (ZOL Genk)

    Genk, 3600

Other trials in Belgium

France2 sites

  • CHRU de Tours - Hôpital Trousseau

    Chambray-lès-Tours, 37170

  • Hôpital Gabriel Montpied, Clermont Ferrand

    Clermont-Ferrand, BP69-63003

Other trials in France

Latvia2 sites

  • Pauls Stradins Clinical University Hospital

    Riga, 1002

  • Riga East Clinical University Hospital

    Riga, 1038

Other trials in Latvia

Netherlands2 sites

  • Onze Lieve Vrouwe Gasthuis Amsterdam (OLVG)

    Amsterdam, 1090

  • Scheperziekenhuis, Treant Zorggroep

    Emmen, 7824AA

Other trials in Netherlands

Poland2 sites

  • Klinika i Katedra Chorób Wewn. i Kardiologii

    Warsaw, 02 097

  • National Institute of Cardiology

    Warsaw, 02 097

Other trials in Poland

Slovakia2 sites

  • SÚSCCH

    Banská Bystrica, 974 01

  • East-Slovak Cardiology Institute (VUSCH)

    Košice, 040 11

Other trials in Slovakia

Austria1 site

  • Kepler Universitätsklinikum

    Linz, Upper Austria, 4020

Other trials in Austria

About this study

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.

Read the 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.

Being tested
BioMonitor
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BioMonitorDevice

    Patients will be implanted with the BioMonitor + Home Monitoring feature

Study groups in NCT02341534
Study groupRoleWhat they receive
BioMonitor armOtherBioMonitor group (implantation with investigational device + transfer of information via Home Monitoring)
Receives: Device: BioMonitor
Control armNo interventionControl group (standard of care)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 years

Secondary outcomes (13)

  1. 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.

    Measured: 2 years

  2. 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.

    Measured: 2 years

  3. 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.

    Measured: 2 years

  4. 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.

    Measured: 2 years

  5. 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.

    Measured: 2 years

  6. 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.

    Measured: 2 years

  7. 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.

    Measured: 2 years

  8. 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.

    Measured: 2 years

  9. 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.

    Measured: 2 years

  10. Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia

    Assessment of the time from randomization to first arrhythmia.

    Measured: 2 years

  11. Type of Initiated Therapies

    Post-hoc categorical summary of most frequent therapies initiated after detection of arrhythmias.

    Measured: All data are collected for the period from randomization until official study end or drop-out, for all enrolled patients, up to 6 years.

  12. 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.

    Measured: 2 years

  13. 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).

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2015 (estimated)
  2. Study start7 Aug 2015
  3. Primary completion3 Nov 2021
  4. Study completion3 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
802 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02341534
Sponsor's protocol ID
HS058
Other IDs
Preserved Ejection Fraction, Implantable Cardiac Device, Loop Recorder, ICM
Acronym
BIO-GUARD-MI
Status last verified
Nov 2022
First submitted
12 Dec 2014
Last updated
13 Apr 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Jons C, Sogaard P, Smilde T, Taborsky M, Falukozy J, Wiemer M, Christensen PD, Erglis A, Khan M, Marti Almor J, Del Prado Diaz S, Rybar I, Vitali Serdoz L, Schrader J, Behrens S; BIO|GUARD-MI study group. Pitfalls in the reporting of clinical events in unblinded device trials: analysing performance bias in the BIO|GUARD-MI trial. Trials. 2026 May 13;27(1):471. doi: 10.1186/s13063-026-09720-5.

    PubMed 42129909

  • 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.

    PubMed 38807948

  • 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.

    PubMed 31511057

Questions about this trial

What is this clinical trial studying?

A study testing BioMonitor in people with Myocardial Infarction and Myocardial Infarction, Acute, run by Biotronik SE & Co. KG at 59 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in Germany, United States, Denmark, Hungary, Australia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kaplan-Meier Estimate of Percentage of Participants With Major Adverse Cardiac Event (MACE) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02341534, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.

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