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

Myocardial Infarction Clinical Trial

— BIO-GUARD-MI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02341534
• Other study ID #: HS058
• Secondary ID: Preserved Ejecti
• Status: Completed
• Phase: N/A
• Start date: August 7, 2015
• Est. completion date: November 3, 2021

Study information

• Verified date: November 2022
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 802
• Est. completion date: November 3, 2021
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Myocardial Infarction Old
• Myocardial Infarction, Acute

Intervention

Device:
• BioMonitor
Patients will be implanted with the BioMonitor + Home Monitoring feature

Locations

Country	Name	City	State
Australia	The Canberra Hospital	Canberra
Australia	Lyell McEwin Hospital (LMH)	Elizabeth Vale	South Australia
Australia	East Metropolitan Health Service Trading AS Royal Perth HOSPITAL	Perth	Western Australia
Austria	Kepler Universitätsklinikum	Linz	Oberösterreich
Belgium	OLV Ziekenhuis Aalst	Aalst
Belgium	Ziekenhuis Oost Limburg Genk (ZOL Genk)	Genk
Czechia	Nemocnice Ceské Budejovice	Ceské Budejovice
Czechia	Fakultní nemocnice Olomouc	Olomouc
Czechia	Institute for Clinical and Experimental Medicine (IKEM)	Praha
Denmark	Aalborg Universitetshospitel	Aalborg
Denmark	Århus Universitetshospital	Århus N
Denmark	Rigshospitalet	Copenhagen
Denmark	Regionshospitalet Herning	Herning
Denmark	Odense University Hospital (OUH)	Odense	Syddanmark
Denmark	Sjaellands Universitets Hospital, Roskilde	Roskilde
Denmark	Regionshospitalet Viborg	Viborg
France	CHRU de Tours - Hôpital Trousseau	Chambray-lès-Tours
France	Hôpital Gabriel Montpied, Clermont Ferrand	Clermont-Ferrand
Germany	Zentralklinik Bad Berka GmbH	Bad Berka
Germany	Herz- und Gefäß- Klinik GmbH Bad Neustadt	Bad Neustadt a.d. Saale
Germany	Charité Universitätsklinikum - Campus Benjamin Franklin	Berlin
Germany	Vivantes Humboldt-Klinikum	Berlin
Germany	Vivantes-Krankenhaus Spandau	Berlin
Germany	Städtisches Krankenhaus Bielefeld-Mitte	Bielefeld
Germany	Klinikum Coburg	Coburg
Germany	Klinikum Fürth	Fürth
Germany	SRH Wald-Klinikum Gera GmbH	Gera
Germany	Ernst-Moritz-Arndt-Universität Greifswald	Greifswald
Germany	Klinikum der Universität Jena	Jena
Germany	Herzzentrum Leipzig GmbH	Leipzig
Germany	Universitätsklinikum Schleswig-Holstein (UKSH) - Campus Lübeck	Lübeck
Germany	Johannes Wesling Klinikum Minden	Minden
Germany	Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH	Villingen-Schwenningen
Germany	Universitätsklinikum Würzburg	Würzburg
Hungary	National Hospital of Cardiology	Balatonfüred
Hungary	Gottsegen György	Budapest
Hungary	Hungarian Defence Forces Military Hospital	Budapest
Hungary	Semmelweis Medical University	Budapest
Hungary	The Debrecen University of Medicine	Debrecen
Hungary	The University of Pécs	Pécs
Latvia	Pauls Stradins Clinical University Hospital	Riga
Latvia	Riga East Clinical University Hospital	Riga
Netherlands	Onze Lieve Vrouwe Gasthuis Amsterdam (OLVG)	Amsterdam
Netherlands	Scheperziekenhuis, Treant Zorggroep	Emmen
Poland	Klinika i Katedra Chorób Wewn. i Kardiologii	Warszawa
Poland	National Institute of Cardiology	Warszawa
Slovakia	SÚSCCH	Banska Bystrica
Slovakia	East-Slovak Cardiology Institute (VUSCH)	Košice
Spain	Hospital del Mar	Barcelona
Spain	Hospital de la Princesa	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
United States	Abington Medical Specialists	Abington	Pennsylvania
United States	Altru Health System	Grand Forks	North Dakota
United States	Metro Knoxville HMA LLC	Knoxville	Tennessee
United States	Carolina Heart Specialists	Lancaster	South Carolina
United States	University of Rochester Medical Center	Rochester	New York
United States	Carolina Cardiology Associates	Rock Hill	South Carolina
United States	Gateway Cardiology	Saint Louis	Missouri
United States	St. Louis Heart and Vascular	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG	IHF GmbH - Institut für Herzinfarktforschung, Qmed Consulting A/S

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Czechia,  Denmark,  France,  Germany,  Hungary,  Latvia,  Netherlands,  Poland,  Slovakia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia	Assessment of the time from randomization to first arrhythmia.	2 years
Secondary	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.
Secondary	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
Secondary	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.