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

• Sponsor: Biotronik SE & Co. KG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02341534
• Collaborator: IHF GmbH - Institut für Herzinfarktforschung (Other), Qmed Consulting A/S (Industry)
• Enrollment: 802
• Locations: 59
• Arms: 2
• Actual Duration (Months): 74.9
• Patients Per Site: 13.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction; Myocardial Infarction, Acute; Myocardial Infarction Old	Device: BioMonitor	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 802 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Diagnostic
• Official Title: BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction
• Actual Study Start Date: Aug 7, 2015
• Actual Primary Completion Date: Nov 3, 2021
• Actual Study Completion Date: Nov 3, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Time to first major adverse cardiac event (MACE) [From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 years.]

   MACE 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

1. All-cause mortality [From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 years.]

   The occurrence of death for any cause will be recorded and analyzed.

2. Time to death from any cause or heart transplantation [From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 years.]

   Assessment of the time from randomization to death for any reason or heart transplantation during the clinical investigation.

3. Time to cardiovascular death or heart transplantation [From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 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.

4. Time to first worsening of the patient status due to heart failure requiring hospitalization or urgent visit [From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 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.

5. Time to first hospitalization resulting from an arrhythmia [From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 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.

6. Time to first hospitalization resulting from acute coronary syndrome [From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 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.

7. Time to first hospitalization resulting from stroke [From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 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.

8. Time to first hospitalization resulting from major bleeding [From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 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.

9. Time to first hospitalization resulting from systemic embolism [From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 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.

10. Time to first arrhythmia [From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 years.]

    Assessment of the time from randomization to first arrhythmia.

11. Type of initiated therapies [From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 years.]

    Evaluation of the diagnoses and consequent type of therapies based on ICM-detected arrhythmias.

12. Time to first therapy [From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 years.]

    Assessment of the time from randomization to first therapy. In this context therapy is the attempted remediation of the patient's regular heartbeat.

13. Quality of Life (QoL) [From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 years.]

    A further secondary endpoint is the assessment of the patient's quality of life. The patient's quality of life will be recorded during the regular telephone contacts using the WHO-5 Wellbeing Index.

Other Outcome Measures

1. EQ-5D-5L [From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 4.0 years.]

   In addition, the EQ-5D-5L questionnaire will be administered during the telephone contacts to estimate utility values at different time points for an economic evaluation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gateway Cardiology	Saint Louis	Missouri	United States	63128
2	St. Louis Heart and Vascular	Saint Louis	Missouri	United States	63136
3	University of Rochester Medical Center	Rochester	New York	United States	14642
4	Altru Health System	Grand Forks	North Dakota	United States	58201
5	Abington Medical Specialists	Abington	Pennsylvania	United States	19001
6	Carolina Heart Specialists	Lancaster	South Carolina	United States	29720
7	Carolina Cardiology Associates	Rock Hill	South Carolina	United States	29732
8	Metro Knoxville HMA LLC	Knoxville	Tennessee	United States	37934
9	Lyell McEwin Hospital (LMH)	Elizabeth Vale	South Australia	Australia	5112
10	East Metropolitan Health Service Trading AS Royal Perth HOSPITAL	Perth	Western Australia	Australia	6000
11	The Canberra Hospital	Canberra		Australia	2605
12	Kepler Universitätsklinikum	Linz	Oberösterreich	Austria	4020
13	OLV Ziekenhuis Aalst	Aalst		Belgium	9300
14	Ziekenhuis Oost Limburg Genk (ZOL Genk)	Genk		Belgium	3600
15	Fakultní nemocnice Olomouc	Olomouc		Czechia	77900
16	Institute for Clinical and Experimental Medicine (IKEM)	Praha		Czechia	14021
17	Nemocnice České Budějovice	České Budějovice		Czechia	37001
18	Odense University Hospital (OUH)	Odense	Syddanmark	Denmark	5000
19	Aalborg Universitetshospitel	Aalborg		Denmark	9100
20	Rigshospitalet	Copenhagen		Denmark	2100
21	Regionshospitalet Herning	Herning		Denmark	7400
22	Sjaellands Universitets Hospital, Roskilde	Roskilde		Denmark	4000
23	Regionshospitalet Viborg	Viborg		Denmark	8800
24	Århus Universitetshospital	Århus N		Denmark	8200-DK
25	CHRU de Tours - Hôpital Trousseau	Chambray-lès-Tours		France	37170
26	Hôpital Gabriel Montpied, Clermont Ferrand	Clermont-Ferrand		France	BP69-63003
27	Zentralklinik Bad Berka GmbH	Bad Berka		Germany	99437
28	Herz- und Gefäß- Klinik GmbH Bad Neustadt	Bad Neustadt a.d. Saale		Germany	97616
29	Charité Universitätsklinikum - Campus Benjamin Franklin	Berlin		Germany	12200
30	Vivantes Humboldt-Klinikum	Berlin		Germany	13509
31	Vivantes-Krankenhaus Spandau	Berlin		Germany	13585
32	Städtisches Krankenhaus Bielefeld-Mitte	Bielefeld		Germany	33604
33	Klinikum Coburg	Coburg		Germany	96450
34	Klinikum Fürth	Fürth		Germany	90766
35	SRH Wald-Klinikum Gera GmbH	Gera		Germany	07548
36	Ernst-Moritz-Arndt-Universität Greifswald	Greifswald		Germany	17475
37	Klinikum der Universität Jena	Jena		Germany	7743
38	Herzzentrum Leipzig GmbH	Leipzig		Germany	04289
39	Universitätsklinikum Schleswig-Holstein (UKSH) - Campus Lübeck	Lübeck		Germany	23562
40	Johannes Wesling Klinikum Minden	Minden		Germany	32429
41	Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH	Villingen-Schwenningen		Germany	78052
42	Universitätsklinikum Würzburg	Würzburg		Germany	97080
43	National Hospital of Cardiology	Balatonfüred		Hungary	8231
44	Gottsegen György	Budapest		Hungary	1096
45	Semmelweis Medical University	Budapest		Hungary	1122
46	Hungarian Defence Forces Military Hospital	Budapest		Hungary	1134
47	The Debrecen University of Medicine	Debrecen		Hungary	4032
48	The University of Pécs	Pécs		Hungary	H-7624
49	Pauls Stradins Clinical University Hospital	Riga		Latvia	1002
50	Riga East Clinical University Hospital	Riga		Latvia	1038
51	Onze Lieve Vrouwe Gasthuis Amsterdam (OLVG)	Amsterdam		Netherlands	1090
52	Scheperziekenhuis, Treant Zorggroep	Emmen		Netherlands	7824AA
53	Klinika i Katedra Chorób Wewn. i Kardiologii	Warszawa		Poland	02 097
54	National Institute of Cardiology	Warszawa		Poland	02 097
55	SÚSCCH	Banska Bystrica		Slovakia	974 01
56	East-Slovak Cardiology Institute (VUSCH)	Košice		Slovakia	040 11
57	Hospital del Mar	Barcelona		Spain	08003
58	Hospital de la Princesa	Madrid		Spain	28006
59	Hospital Universitario Ramón y Cajal	Madrid		Spain	28034

Sponsors and Collaborators

• Biotronik SE & Co. KG
• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biotronik SE & Co. KG
• ClinicalTrials.gov Identifier: NCT02341534
• Other Study ID Numbers: HS058; Preserved Ejection Fraction; Implantable Cardiac Device; Loop Recorder; ICM
• First Posted: Jan 19, 2015
• Last Update Posted: Jan 21, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Myocardial Infarction; Infarction

Study Results

No Results Posted as of Jan 21, 2022