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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02341534
Ethics application status
Date submitted
12/12/2014
Date registered
19/01/2015
Date last updated
13/04/2023

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

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


Treatment: Devices: BioMonitor
Patients will be implanted with the BioMonitor + Home Monitoring feature
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Kaplan-Meier Estimate of Percentage of Participants With Major Adverse Cardiac Event (MACE)
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Kaplan-Meier Estimate of Percentage of Participants With Outcome of Death Due to Any Cause
Assessment method [1] 0 0
The occurrence of death due to any cause will be recorded and analyzed.
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Kaplan-Meier Estimate of Percentage of Participants With Outcome of Death Due to Any Cause or Heart Transplantation
Assessment method [2] 0 0
Assessment of the time from randomization to death for any reason or heart transplantation during the clinical investigation.
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Kaplan-Meier Estimate of Percentage of Participants With Outcome of Cardiovascular Death or Heart Transplantation
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Kaplan-Meier Estimate of Percentage of Participants With Worsening of Heart Failure Requiring Hospitalization or Urgent Visit
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia Resulting in Hospitalization
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Kaplan-Meier Estimate of Percentage of Participants With Acute Coronary Syndrome Resulting in Hospitalization
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
Kaplan-Meier Estimate of Percentage of Participants With Stroke Resulting in Hospitalization
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
2 years
Secondary outcome [8] 0 0
Kaplan-Meier Estimate of Percentage of Participants With Major Bleeding Resulting in Hospitalization
Assessment method [8] 0 0
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.
Timepoint [8] 0 0
2 years
Secondary outcome [9] 0 0
Kaplan-Meier Estimate of Percentage of Participants With Systemic Embolism Resulting in Hospitalization
Assessment method [9] 0 0
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.
Timepoint [9] 0 0
2 years
Secondary outcome [10] 0 0
Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia
Assessment method [10] 0 0
Assessment of the time from randomization to first arrhythmia.
Timepoint [10] 0 0
2 years
Secondary outcome [11] 0 0
Type of Initiated Therapies
Assessment method [11] 0 0
Post-hoc categorical summary of most frequent therapies initiated after detection of arrhythmias.
Timepoint [11] 0 0
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 outcome [12] 0 0
Kaplan-Meier Estimate of Percentage of Participants Receiving Therapy After Arrhythmia Diagnosis
Assessment method [12] 0 0
Assessment of the time from randomization to first therapy. In this context therapy is the attempted remediation of the patient's regular heartbeat.
Timepoint [12] 0 0
2 years
Secondary outcome [13] 0 0
Change in World Health Organization Five Well-being Index (WHO-5) From 6 Months to 24 Months.
Assessment method [13] 0 0
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).
Timepoint [13] 0 0
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.

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
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/11/2021
Sample size
Target
Accrual to date
Final
802
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Lyell McEwin Hospital (LMH) - Elizabeth Vale
Recruitment hospital [2] 0 0
East Metropolitan Health Service Trading AS Royal Perth HOSPITAL - Perth
Recruitment hospital [3] 0 0
The Canberra Hospital - Canberra
Recruitment postcode(s) [1] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [2] 0 0
6000 - Perth
Recruitment postcode(s) [3] 0 0
2605 - Canberra
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Missouri
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
North Dakota
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
South Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
Austria
State/province [7] 0 0
Oberösterreich
Country [8] 0 0
Belgium
State/province [8] 0 0
Aalst
Country [9] 0 0
Belgium
State/province [9] 0 0
Genk
Country [10] 0 0
Czechia
State/province [10] 0 0
Olomouc
Country [11] 0 0
Czechia
State/province [11] 0 0
Praha
Country [12] 0 0
Czechia
State/province [12] 0 0
Ceské Budejovice
Country [13] 0 0
Denmark
State/province [13] 0 0
Syddanmark
Country [14] 0 0
Denmark
State/province [14] 0 0
Aalborg
Country [15] 0 0
Denmark
State/province [15] 0 0
Copenhagen
Country [16] 0 0
Denmark
State/province [16] 0 0
Herning
Country [17] 0 0
Denmark
State/province [17] 0 0
Roskilde
Country [18] 0 0
Denmark
State/province [18] 0 0
Viborg
Country [19] 0 0
Denmark
State/province [19] 0 0
Århus N
Country [20] 0 0
France
State/province [20] 0 0
Chambray-lès-Tours
Country [21] 0 0
France
State/province [21] 0 0
Clermont-Ferrand
Country [22] 0 0
Germany
State/province [22] 0 0
Bad Berka
Country [23] 0 0
Germany
State/province [23] 0 0
Bad Neustadt a.d. Saale
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Bielefeld
Country [26] 0 0
Germany
State/province [26] 0 0
Coburg
Country [27] 0 0
Germany
State/province [27] 0 0
Fürth
Country [28] 0 0
Germany
State/province [28] 0 0
Gera
Country [29] 0 0
Germany
State/province [29] 0 0
Greifswald
Country [30] 0 0
Germany
State/province [30] 0 0
Jena
Country [31] 0 0
Germany
State/province [31] 0 0
Leipzig
Country [32] 0 0
Germany
State/province [32] 0 0
Lübeck
Country [33] 0 0
Germany
State/province [33] 0 0
Minden
Country [34] 0 0
Germany
State/province [34] 0 0
Villingen-Schwenningen
Country [35] 0 0
Germany
State/province [35] 0 0
Würzburg
Country [36] 0 0
Hungary
State/province [36] 0 0
Balatonfüred
Country [37] 0 0
Hungary
State/province [37] 0 0
Budapest
Country [38] 0 0
Hungary
State/province [38] 0 0
Debrecen
Country [39] 0 0
Hungary
State/province [39] 0 0
Pécs
Country [40] 0 0
Latvia
State/province [40] 0 0
Riga
Country [41] 0 0
Netherlands
State/province [41] 0 0
Amsterdam
Country [42] 0 0
Netherlands
State/province [42] 0 0
Emmen
Country [43] 0 0
Poland
State/province [43] 0 0
Warszawa
Country [44] 0 0
Slovakia
State/province [44] 0 0
Banska Bystrica
Country [45] 0 0
Slovakia
State/province [45] 0 0
Košice
Country [46] 0 0
Spain
State/province [46] 0 0
Barcelona
Country [47] 0 0
Spain
State/province [47] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biotronik SE & Co. KG
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
IHF GmbH - Institut für Herzinfarktforschung
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Qmed Consulting A/S
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02341534