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

NCT02341534 | Completed Results DMC FDA Device

• 5 other identifiers: HS058Preserved Ejection FractionImplantable Cardiac DeviceLoop RecorderICM
• Study Type: interventional
• Target: 802
• Locations: 13 countries
• Sites: 58

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.

Conditions

Myocardial Infarction; Myocardial Infarction, Acute; Myocardial Infarction Old

Outcome Measures

Primary Outcomes (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.

  2 years

Secondary Outcomes (13)

• Kaplan-Meier Estimate of Percentage of Participants With Outcome of Death Due to Any Cause

  2 years

• Kaplan-Meier Estimate of Percentage of Participants With Outcome of Death Due to Any Cause or Heart Transplantation

  2 years

• Kaplan-Meier Estimate of Percentage of Participants With Outcome of Cardiovascular Death or Heart Transplantation

  2 years

• Kaplan-Meier Estimate of Percentage of Participants With Worsening of Heart Failure Requiring Hospitalization or Urgent Visit

  2 years

• Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia Resulting in Hospitalization

  2 years

Other Outcomes (1)

• Mean Value of EQ-5D-5L

  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.

Study Arms (2)

BioMonitor arm

OTHER

BioMonitor group (implantation with investigational device + transfer of information via Home Monitoring)

Device: BioMonitor

Control arm

NO INTERVENTION

Control group (standard of care)

Interventions

BioMonitor DEVICE

Patients will be implanted with the BioMonitor + Home Monitoring feature

BioMonitor arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead
• IHF GmbH - Institut für Herzinfarktforschung: collaborator
• Qmed Consulting A/S: collaborator

Study Sites (59)

Gateway Cardiology

St Louis, Missouri, 63128, United States

Location

St. Louis Heart and Vascular

St Louis, Missouri, 63136, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Altru Health System

Grand Forks, North Dakota, 58201, United States

Location

Abington Medical Specialists

Abington, Pennsylvania, 19001, United States

Location

Carolina Heart Specialists

Lancaster, South Carolina, 29720, United States

Location

Carolina Cardiology Associates

Rock Hill, South Carolina, 29732, United States

Location

Metro Knoxville HMA LLC

Knoxville, Tennessee, 37934, United States

Location

Lyell McEwin Hospital (LMH)

Elizabeth Vale, South Australia, 5112, Australia

Location

East Metropolitan Health Service Trading AS Royal Perth HOSPITAL

Perth, Western Australia, 6000, Australia

Location

The Canberra Hospital

Canberra, 2605, Australia

Location

Kepler Universitätsklinikum

Linz, Upper Austria, 4020, Austria

Location

OLV Ziekenhuis Aalst

Aalst, 9300, Belgium

Location

Ziekenhuis Oost Limburg Genk (ZOL Genk)

Genk, 3600, Belgium

Location

Nemocnice České Budějovice

České Budějovice, 37001, Czechia

Location

Fakultní nemocnice Olomouc

Olomouc, 77900, Czechia

Location

Institute for Clinical and Experimental Medicine (IKEM)

Prague, 14021, Czechia

Location

Odense University Hospital (OUH)

Odense, Region Syddanmark, 5000, Denmark

Location

Aalborg Universitetshospitel

Aalborg, 9100, Denmark

Location

Århus Universitetshospital

Århus N, 8200-DK, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Regionshospitalet Herning

Herning, 7400, Denmark

Location

Sjaellands Universitets Hospital, Roskilde

Roskilde, 4000, Denmark

Location

Regionshospitalet Viborg

Viborg, 8800, Denmark

Location

CHRU de Tours - Hôpital Trousseau

Chambray-lès-Tours, 37170, France

Location

Hôpital Gabriel Montpied, Clermont Ferrand

Clermont-Ferrand, BP69-63003, France

Location

Zentralklinik Bad Berka GmbH

Bad Berka, 99437, Germany

Location

Herz- und Gefäß- Klinik GmbH Bad Neustadt

Bad Neustadt A.d. Saale, 97616, Germany

Location

Charité Universitätsklinikum - Campus Benjamin Franklin

Berlin, 12200, Germany

Location

Vivantes Humboldt-Klinikum

Berlin, 13509, Germany

Location

Vivantes-Krankenhaus Spandau

Berlin, 13585, Germany

Location

Städtisches Krankenhaus Bielefeld-Mitte

Bielefeld, 33604, Germany

Location

Klinikum Coburg

Coburg, 96450, Germany

Location

Klinikum Fürth

Fürth, 90766, Germany

Location

SRH Wald-Klinikum Gera GmbH

Gera, 07548, Germany

Location

Ernst-Moritz-Arndt-Universität Greifswald

Greifswald, 17475, Germany

Location

Klinikum der Universität Jena

Jena, 7743, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany

Location

Universitätsklinikum Schleswig-Holstein (UKSH) - Campus Lübeck

Lübeck, 23562, Germany

Location

Johannes Wesling Klinikum Minden

Minden, 32429, Germany

Location

Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

Villingen-Schwenningen, 78052, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

National Hospital of Cardiology

Balatonfüred, 8231, Hungary

Location

Gottsegen György

Budapest, 1096, Hungary

Location

Semmelweis Medical University

Budapest, 1122, Hungary

Location

Hungarian Defence Forces Military Hospital

Budapest, 1134, Hungary

Location

The Debrecen University of Medicine

Debrecen, 4032, Hungary

Location

The University of Pécs

Pécs, H-7624, Hungary

Location

Pauls Stradins Clinical University Hospital

Riga, 1002, Latvia

Location

Riga East Clinical University Hospital

Riga, 1038, Latvia

Location

Onze Lieve Vrouwe Gasthuis Amsterdam (OLVG)

Amsterdam, 1090, Netherlands

Location

Scheperziekenhuis, Treant Zorggroep

Emmen, 7824AA, Netherlands

Location

Klinika i Katedra Chorób Wewn. i Kardiologii

Warsaw, 02 097, Poland

Location

National Institute of Cardiology

Warsaw, 02 097, Poland

Location

SÚSCCH

Banská Bystrica, 974 01, Slovakia

Location

East-Slovak Cardiology Institute (VUSCH)

Košice, 040 11, Slovakia

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital de la Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Related Publications (2)

• 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.

  PMID: 38807948 DERIVED

• 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.

  PMID: 31511057 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Sascha Mrosk, Senior Clinical Project Manager
• Organization: BIOTRONIK SE & Co. KG

sascha.mrosk@biotronik.com

15168901308

Study Officials

• Christian Jons, Doctor

  Rigshospitalet; Denmark; Copenhagen

  STUDY CHAIR

• Steffen Behrens, Professor

  Vivantes Humboldt Klinikum, Germany, Berlin

  PRINCIPAL INVESTIGATOR

• Poul Erik Bloch Thomsen, Professor

  Aalborg University Hospital, Denmark, Aalborg

  STUDY DIRECTOR

• Peter Sogaard, Professor

  Aalborg University Hospital, Denmark, Aalborg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An independent Endpoint Committee was installed to evaluate all reported cardiovascular and serious AEs. The information provided to the Committee did not contain information about the group assigment of the patients.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2014
• First Posted: January 19, 2015
• Study Start: August 7, 2015
• Primary Completion: November 3, 2021
• Study Completion: November 3, 2021
• Last Updated: April 13, 2023
• Results First Posted: April 13, 2023

Record last verified: 2022-11

Locations

SL (2); FR (2); AU (3); CZ (3); US (8); BE (2); DE (16); HU (6); LA (2); PL (2); DK (7); NL (2); ES (3)