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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02341534




Registration number
NCT02341534
Ethics application status
Date submitted
12/12/2014
Date registered
19/01/2015
Date last updated
24/04/2020

Titles & IDs
Public title
BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction
Scientific title
BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction
Secondary ID [1] 0 0
Preserved Ejection Fraction
Secondary ID [2] 0 0
HS058
Universal Trial Number (UTN)
Trial acronym
BIO-GUARD-MI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction 0 0
Myocardial Infarction, Acute 0 0
Myocardial Infarction Old 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - BioMonitor

Other: BioMonitor arm - BioMonitor group (standard of care and implantation with investigational device)

No Intervention: Control arm - Control group (standard of care)


Treatment: Devices: BioMonitor
Patients will be implanted with the BioMonitor + standard of care

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first major cardiac adverse event (MACE) - 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.
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.
Timepoint [1] 0 0
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.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Platelet count < 90.000 per mm3 or 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
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Lyell McEwin Hospital (LMH) - Elizabeth Vale
Recruitment hospital [2] 0 0
Joondalup Health Campus - Joondalup
Recruitment hospital [3] 0 0
The Canberra Hospital - Canberra
Recruitment postcode(s) [1] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [2] 0 0
6027 - Joondalup
Recruitment postcode(s) [3] 0 0
2605 - Canberra
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
North Dakota
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
Austria
State/province [11] 0 0
Oberösterreich
Country [12] 0 0
Belgium
State/province [12] 0 0
Aalst
Country [13] 0 0
Belgium
State/province [13] 0 0
Genk
Country [14] 0 0
Czechia
State/province [14] 0 0
Olomouc
Country [15] 0 0
Czechia
State/province [15] 0 0
Praha
Country [16] 0 0
Czechia
State/province [16] 0 0
Ceské Budejovice
Country [17] 0 0
Denmark
State/province [17] 0 0
Syddanmark
Country [18] 0 0
Denmark
State/province [18] 0 0
Aalborg
Country [19] 0 0
Denmark
State/province [19] 0 0
Copenhagen
Country [20] 0 0
Denmark
State/province [20] 0 0
Herning
Country [21] 0 0
Denmark
State/province [21] 0 0
Roskilde
Country [22] 0 0
Denmark
State/province [22] 0 0
Viborg
Country [23] 0 0
Denmark
State/province [23] 0 0
Århus N
Country [24] 0 0
France
State/province [24] 0 0
Chambray-lès-Tours
Country [25] 0 0
France
State/province [25] 0 0
Clermont-Ferrand
Country [26] 0 0
France
State/province [26] 0 0
Marseille
Country [27] 0 0
Germany
State/province [27] 0 0
Bad Berka
Country [28] 0 0
Germany
State/province [28] 0 0
Bad Neustadt a.d. Saale
Country [29] 0 0
Germany
State/province [29] 0 0
Berlin
Country [30] 0 0
Germany
State/province [30] 0 0
Bielefeld
Country [31] 0 0
Germany
State/province [31] 0 0
Coburg
Country [32] 0 0
Germany
State/province [32] 0 0
Fürth
Country [33] 0 0
Germany
State/province [33] 0 0
Gera
Country [34] 0 0
Germany
State/province [34] 0 0
Greifswald
Country [35] 0 0
Germany
State/province [35] 0 0
Jena
Country [36] 0 0
Germany
State/province [36] 0 0
Leipzig
Country [37] 0 0
Germany
State/province [37] 0 0
Lübeck
Country [38] 0 0
Germany
State/province [38] 0 0
Minden
Country [39] 0 0
Germany
State/province [39] 0 0
Villingen-Schwenningen
Country [40] 0 0
Germany
State/province [40] 0 0
Würzburg
Country [41] 0 0
Hungary
State/province [41] 0 0
Balatonfüred
Country [42] 0 0
Hungary
State/province [42] 0 0
Budapest
Country [43] 0 0
Hungary
State/province [43] 0 0
Debrecen
Country [44] 0 0
Hungary
State/province [44] 0 0
Pécs
Country [45] 0 0
Latvia
State/province [45] 0 0
Riga
Country [46] 0 0
Netherlands
State/province [46] 0 0
Amsterdam
Country [47] 0 0
Netherlands
State/province [47] 0 0
Emmen
Country [48] 0 0
Poland
State/province [48] 0 0
Warszawa
Country [49] 0 0
Slovakia
State/province [49] 0 0
Banska Bystrica
Country [50] 0 0
Slovakia
State/province [50] 0 0
KoŇ°ice
Country [51] 0 0
Spain
State/province [51] 0 0
Barcelona
Country [52] 0 0
Spain
State/province [52] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biotronik SE & Co. KG
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02341534
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christian Jons, Doctor
Address 0 0
Rigshospitalet; Denmark; Copenhagen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications