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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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Scientific title
BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction
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Secondary ID [1]
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Preserved Ejection Fraction
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Secondary ID [2]
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HS058
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Universal Trial Number (UTN)
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Trial acronym
BIO-GUARD-MI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction
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Myocardial Infarction, Acute
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Myocardial Infarction Old
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Kaplan-Meier Estimate of Percentage of Participants With Major Adverse Cardiac Event (MACE)
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Assessment method [1]
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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.
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Timepoint [1]
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2 years
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Secondary outcome [1]
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Kaplan-Meier Estimate of Percentage of Participants With Outcome of Death Due to Any Cause
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Assessment method [1]
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The occurrence of death due to any cause will be recorded and analyzed.
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Timepoint [1]
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2 years
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Secondary outcome [2]
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Kaplan-Meier Estimate of Percentage of Participants With Outcome of Death Due to Any Cause or Heart Transplantation
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Assessment method [2]
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Assessment of the time from randomization to death for any reason or heart transplantation during the clinical investigation.
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Timepoint [2]
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2 years
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Secondary outcome [3]
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Kaplan-Meier Estimate of Percentage of Participants With Outcome of Cardiovascular Death or Heart Transplantation
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Assessment method [3]
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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.
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Timepoint [3]
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2 years
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Secondary outcome [4]
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Kaplan-Meier Estimate of Percentage of Participants With Worsening of Heart Failure Requiring Hospitalization or Urgent Visit
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Assessment method [4]
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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.
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Timepoint [4]
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2 years
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Secondary outcome [5]
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Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia Resulting in Hospitalization
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Assessment method [5]
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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.
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Timepoint [5]
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2 years
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Secondary outcome [6]
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Kaplan-Meier Estimate of Percentage of Participants With Acute Coronary Syndrome Resulting in Hospitalization
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Assessment method [6]
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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.
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Timepoint [6]
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2 years
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Secondary outcome [7]
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Kaplan-Meier Estimate of Percentage of Participants With Stroke Resulting in Hospitalization
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Assessment method [7]
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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.
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Timepoint [7]
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2 years
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Secondary outcome [8]
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Kaplan-Meier Estimate of Percentage of Participants With Major Bleeding Resulting in Hospitalization
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Assessment method [8]
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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.
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Timepoint [8]
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2 years
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Secondary outcome [9]
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Kaplan-Meier Estimate of Percentage of Participants With Systemic Embolism Resulting in Hospitalization
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Assessment method [9]
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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.
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Timepoint [9]
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2 years
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Secondary outcome [10]
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Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia
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Assessment method [10]
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Assessment of the time from randomization to first arrhythmia.
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Timepoint [10]
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2 years
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Secondary outcome [11]
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Type of Initiated Therapies
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Assessment method [11]
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Post-hoc categorical summary of most frequent therapies initiated after detection of arrhythmias.
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Timepoint [11]
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All data are collected for the period from randomization until official study end or drop-out, for all enrolled patients, up to 6 years.
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Secondary outcome [12]
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Kaplan-Meier Estimate of Percentage of Participants Receiving Therapy After Arrhythmia Diagnosis
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Assessment method [12]
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Assessment of the time from randomization to first therapy. In this context therapy is the attempted remediation of the patient's regular heartbeat.
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Timepoint [12]
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2 years
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Secondary outcome [13]
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Change in World Health Organization Five Well-being Index (WHO-5) From 6 Months to 24 Months.
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Assessment method [13]
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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).
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Timepoint [13]
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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.
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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
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Minimum age
18
Years
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Maximum age
99
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/08/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
3/11/2021
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Sample size
Target
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Accrual to date
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Final
802
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Recruitment in Australia
Recruitment state(s)
SA,WA
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Recruitment hospital [1]
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Lyell McEwin Hospital (LMH) - Elizabeth Vale
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Recruitment hospital [2]
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East Metropolitan Health Service Trading AS Royal Perth HOSPITAL - Perth
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Recruitment hospital [3]
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The Canberra Hospital - Canberra
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Recruitment postcode(s) [1]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [2]
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6000 - Perth
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Recruitment postcode(s) [3]
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2605 - Canberra
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Missouri
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Country [2]
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United States of America
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State/province [2]
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New York
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Country [3]
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United States of America
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State/province [3]
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North Dakota
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Country [4]
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United States of America
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State/province [4]
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Pennsylvania
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Country [5]
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United States of America
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State/province [5]
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South Carolina
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Country [6]
0
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United States of America
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State/province [6]
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Tennessee
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Country [7]
0
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Austria
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State/province [7]
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Oberösterreich
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Country [8]
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Belgium
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State/province [8]
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Aalst
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Country [9]
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Belgium
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State/province [9]
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Genk
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Country [10]
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Czechia
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State/province [10]
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Olomouc
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Country [11]
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Czechia
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State/province [11]
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Praha
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Country [12]
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Czechia
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State/province [12]
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Ceské Budejovice
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Country [13]
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Denmark
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State/province [13]
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Syddanmark
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Country [14]
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Denmark
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State/province [14]
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Aalborg
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Country [15]
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Denmark
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State/province [15]
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Copenhagen
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Country [16]
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Denmark
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State/province [16]
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Herning
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Country [17]
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Denmark
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State/province [17]
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Roskilde
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Country [18]
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Denmark
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State/province [18]
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Viborg
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Country [19]
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Denmark
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State/province [19]
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Århus N
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Country [20]
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France
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State/province [20]
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Chambray-lès-Tours
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Country [21]
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France
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State/province [21]
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Clermont-Ferrand
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Country [22]
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Germany
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State/province [22]
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Bad Berka
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Country [23]
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Germany
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State/province [23]
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Bad Neustadt a.d. Saale
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Country [24]
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Germany
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State/province [24]
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Berlin
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Country [25]
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Germany
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State/province [25]
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Bielefeld
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Country [26]
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Germany
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State/province [26]
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Coburg
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Country [27]
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Germany
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State/province [27]
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Fürth
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Country [28]
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Germany
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State/province [28]
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Gera
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Country [29]
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Germany
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State/province [29]
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Greifswald
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Country [30]
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Germany
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State/province [30]
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Jena
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Country [31]
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Germany
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State/province [31]
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Leipzig
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Country [32]
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Germany
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State/province [32]
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Lübeck
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Country [33]
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Germany
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State/province [33]
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Minden
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Country [34]
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Germany
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State/province [34]
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Villingen-Schwenningen
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Country [35]
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Germany
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State/province [35]
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Würzburg
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Country [36]
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Hungary
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State/province [36]
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Balatonfüred
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Country [37]
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Hungary
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State/province [37]
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Budapest
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Country [38]
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Hungary
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State/province [38]
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Debrecen
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Country [39]
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Hungary
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State/province [39]
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Pécs
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Country [40]
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Latvia
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State/province [40]
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Riga
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Country [41]
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Netherlands
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State/province [41]
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Amsterdam
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Country [42]
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Netherlands
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State/province [42]
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Emmen
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Country [43]
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Poland
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State/province [43]
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Warszawa
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Country [44]
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Slovakia
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State/province [44]
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Banska Bystrica
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Country [45]
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Slovakia
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State/province [45]
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Košice
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Country [46]
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Spain
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State/province [46]
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Barcelona
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Country [47]
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Spain
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State/province [47]
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Biotronik SE & Co. KG
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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IHF GmbH - Institut für Herzinfarktforschung
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Address [1]
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Country [1]
0
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Other collaborator category [2]
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Commercial sector/Industry
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Name [2]
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Qmed Consulting A/S
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02341534
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Christian Jons, Doctor
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Address
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Rigshospitalet; Denmark; Copenhagen
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Country
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Phone
0
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02341534
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