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

Not Applicable

Completed

• Conditions: Myocardial Infarction; Myocardial Infarction Old; Myocardial Infarction, Acute
• Interventions: Device: BioMonitor

• Registration Number: NCT02341534
• Lead Sponsor: Biotronik SE & Co. KG

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.

Study Timeline

• Study First Submitted: 2014-12-12
• Study First Submitted QC: 2015-01-14
• Study First Posted: 2015-01-19
• Study Start: 2015-08-07
• Primary Completion: 2021-11-03
• Study Completion: 2021-11-03
• Status Verified: 2022-11
• Results First Submitted: 2022-11-02
• Results First Submitted QC: 2023-03-20
• Last Update Submitted: 2023-03-20
• Results First Posted: 2023-04-13
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 802

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BioMonitor arm	BioMonitor	BioMonitor group (implantation with investigational device + transfer of information via Home Monitoring)

Primary Outcome Measures

Name	Time	Method
Kaplan-Meier Estimate of Percentage of Participants With Major Adverse Cardiac Event (MACE)	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia Resulting in Hospitalization	2 years	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.
Kaplan-Meier Estimate of Percentage of Participants With Major Bleeding Resulting in Hospitalization	2 years	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.
Kaplan-Meier Estimate of Percentage of Participants With Outcome of Death Due to Any Cause	2 years	The occurrence of death due to any cause will be recorded and analyzed.
Kaplan-Meier Estimate of Percentage of Participants With Outcome of Cardiovascular Death or Heart Transplantation	2 years	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.
Kaplan-Meier Estimate of Percentage of Participants With Acute Coronary Syndrome Resulting in Hospitalization	2 years	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.
Type of Initiated Therapies	All data are collected for the period from randomization until official study end or drop-out, for all enrolled patients, up to 6 years.	Post-hoc categorical summary of most frequent therapies initiated after detection of arrhythmias.
Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia	2 years	Assessment of the time from randomization to first arrhythmia.
Kaplan-Meier Estimate of Percentage of Participants Receiving Therapy After Arrhythmia Diagnosis	2 years	Assessment of the time from randomization to first therapy. In this context therapy is the attempted remediation of the patient's regular heartbeat.
Kaplan-Meier Estimate of Percentage of Participants With Outcome of Death Due to Any Cause or Heart Transplantation	2 years	Assessment of the time from randomization to death for any reason or heart transplantation during the clinical investigation.
Kaplan-Meier Estimate of Percentage of Participants With Worsening of Heart Failure Requiring Hospitalization or Urgent Visit	2 years	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.
Kaplan-Meier Estimate of Percentage of Participants With Stroke Resulting in Hospitalization	2 years	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.
Kaplan-Meier Estimate of Percentage of Participants With Systemic Embolism Resulting in Hospitalization	2 years	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.
Change in World Health Organization Five Well-being Index (WHO-5) From 6 Months to 24 Months.	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.	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).

Trial Locations

Locations (59)

Metro Knoxville HMA LLC; 🇺🇸 Knoxville, Tennessee, United States

Ziekenhuis Oost Limburg Genk (ZOL Genk); 🇧🇪 Genk, Belgium

Onze Lieve Vrouwe Gasthuis Amsterdam (OLVG); 🇳🇱 Amsterdam, Netherlands

Scheperziekenhuis, Treant Zorggroep; 🇳🇱 Emmen, Netherlands

Klinika i Katedra Chorób Wewn. i Kardiologii; 🇵🇱 Warszawa, Poland

Carolina Heart Specialists; 🇺🇸 Lancaster, South Carolina, United States

The Debrecen University of Medicine; 🇭🇺 Debrecen, Hungary

National Institute of Cardiology; 🇵🇱 Warszawa, Poland

SÚSCCH; 🇸🇰 Banska Bystrica, Slovakia

Semmelweis Medical University; 🇭🇺 Budapest, Hungary

East-Slovak Cardiology Institute (VUSCH); 🇸🇰 Košice, Slovakia

Hungarian Defence Forces Military Hospital; 🇭🇺 Budapest, Hungary

Regionshospitalet Viborg; 🇩🇰 Viborg, Denmark

Gateway Cardiology; 🇺🇸 Saint Louis, Missouri, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

Altru Health System; 🇺🇸 Grand Forks, North Dakota, United States

St. Louis Heart and Vascular; 🇺🇸 Saint Louis, Missouri, United States

Carolina Cardiology Associates; 🇺🇸 Rock Hill, South Carolina, United States

East Metropolitan Health Service Trading AS Royal Perth HOSPITAL; 🇦🇺 Perth, Western Australia, Australia

The Canberra Hospital; 🇦🇺 Canberra, Australia

Kepler Universitätsklinikum; 🇦🇹 Linz, Oberösterreich, Austria

Odense University Hospital (OUH); 🇩🇰 Odense, Syddanmark, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Aalborg Universitetshospitel; 🇩🇰 Aalborg, Denmark

Regionshospitalet Herning; 🇩🇰 Herning, Denmark

Sjaellands Universitets Hospital, Roskilde; 🇩🇰 Roskilde, Denmark

Hôpital Gabriel Montpied, Clermont Ferrand; 🇫🇷 Clermont-Ferrand, France

Århus Universitetshospital; 🇩🇰 Århus N, Denmark

Zentralklinik Bad Berka GmbH; 🇩🇪 Bad Berka, Germany

CHRU de Tours - Hôpital Trousseau; 🇫🇷 Chambray-lès-Tours, France

Charité Universitätsklinikum - Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

Klinikum Coburg; 🇩🇪 Coburg, Germany

Vivantes Humboldt-Klinikum; 🇩🇪 Berlin, Germany

Städtisches Krankenhaus Bielefeld-Mitte; 🇩🇪 Bielefeld, Germany

Vivantes-Krankenhaus Spandau; 🇩🇪 Berlin, Germany

Ernst-Moritz-Arndt-Universität Greifswald; 🇩🇪 Greifswald, Germany

Klinikum Fürth; 🇩🇪 Fürth, Germany

SRH Wald-Klinikum Gera GmbH; 🇩🇪 Gera, Germany

Universitätsklinikum Schleswig-Holstein (UKSH) - Campus Lübeck; 🇩🇪 Lübeck, Germany

Klinikum der Universität Jena; 🇩🇪 Jena, Germany

Herzzentrum Leipzig GmbH; 🇩🇪 Leipzig, 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

Riga East Clinical University Hospital; 🇱🇻 Riga, Latvia

Pauls Stradins Clinical University Hospital; 🇱🇻 Riga, Latvia

The University of Pécs; 🇭🇺 Pécs, Hungary

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital de la Princesa; 🇪🇸 Madrid, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Lyell McEwin Hospital (LMH); 🇦🇺 Elizabeth Vale, South Australia, Australia

Institute for Clinical and Experimental Medicine (IKEM); 🇨🇿 Praha, Czechia

Abington Medical Specialists; 🇺🇸 Abington, Pennsylvania, United States

OLV Ziekenhuis Aalst; 🇧🇪 Aalst, Belgium

Fakultní nemocnice Olomouc; 🇨🇿 Olomouc, Czechia

Nemocnice České Budějovice; 🇨🇿 České Budějovice, Czechia

Herz- und Gefäß- Klinik GmbH Bad Neustadt; 🇩🇪 Bad Neustadt a.d. Saale, Germany