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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02341534
Recruitment Status : Completed
First Posted : January 19, 2015
Results First Posted : April 13, 2023
Last Update Posted : April 13, 2023
Sponsor:
Collaborators:
IHF GmbH - Institut für Herzinfarktforschung
Qmed Consulting A/S
Information provided by (Responsible Party):
Biotronik SE & Co. KG

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : August 7, 2015
Actual Primary Completion Date : November 3, 2021
Actual Study Completion Date : November 3, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Arm Intervention/treatment
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
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Primary Outcome Measures :
  1. Kaplan-Meier Estimate of Percentage of Participants With Major Adverse Cardiac Event (MACE) [ Time Frame: 2 years ]

    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.



Secondary Outcome Measures :
  1. Kaplan-Meier Estimate of Percentage of Participants With Outcome of Death Due to Any Cause [ Time Frame: 2 years ]
    The occurrence of death due to any cause will be recorded and analyzed.

  2. Kaplan-Meier Estimate of Percentage of Participants With Outcome of Death Due to Any Cause or Heart Transplantation [ Time Frame: 2 years ]
    Assessment of the time from randomization to death for any reason or heart transplantation during the clinical investigation.

  3. Kaplan-Meier Estimate of Percentage of Participants With Outcome of Cardiovascular Death or Heart Transplantation [ Time Frame: 2 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. Kaplan-Meier Estimate of Percentage of Participants With Worsening of Heart Failure Requiring Hospitalization or Urgent Visit [ Time Frame: 2 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. Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia Resulting in Hospitalization [ Time Frame: 2 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. Kaplan-Meier Estimate of Percentage of Participants With Acute Coronary Syndrome Resulting in Hospitalization [ Time Frame: 2 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. Kaplan-Meier Estimate of Percentage of Participants With Stroke Resulting in Hospitalization [ Time Frame: 2 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. Kaplan-Meier Estimate of Percentage of Participants With Major Bleeding Resulting in Hospitalization [ Time Frame: 2 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. Kaplan-Meier Estimate of Percentage of Participants With Systemic Embolism Resulting in Hospitalization [ Time Frame: 2 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. Kaplan-Meier Estimate of Percentage of Participants With an Arrhythmia [ Time Frame: 2 years ]
    Assessment of the time from randomization to first arrhythmia.

  11. Type of Initiated Therapies [ Time Frame: All data are collected for the period from randomization until official study end or drop-out, for all enrolled patients, up to 6 years. ]
    Post-hoc categorical summary of most frequent therapies initiated after detection of arrhythmias.

  12. Kaplan-Meier Estimate of Percentage of Participants Receiving Therapy After Arrhythmia Diagnosis [ Time Frame: 2 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. Change in World Health Organization Five Well-being Index (WHO-5) From 6 Months to 24 Months. [ Time Frame: 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. ]
    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).


Other Outcome Measures:
  1. Mean Value of EQ-5D-5L [ Time Frame: 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. ]

    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).



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341534


Locations
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Sponsors and Collaborators
Biotronik SE & Co. KG
IHF GmbH - Institut für Herzinfarktforschung
Qmed Consulting A/S
Investigators
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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)

Documents provided by Biotronik SE & Co. KG:
Study Protocol: Study Protocol used in the USA  [PDF] June 12, 2019
Study Protocol: Modification to study protocol used in the USA  [PDF] April 6, 2021
Study Protocol: Study Protocol used outside the USA (OUS)  [PDF] April 6, 2021
Statistical Analysis Plan  [PDF] February 3, 2022

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT02341534    
Other Study ID Numbers: HS058
Preserved Ejection Fraction ( Other Identifier: BIOTRONIK )
Implantable Cardiac Device ( Other Identifier: BIOTRONIK )
Loop Recorder ( Other Identifier: BIOTRONIK )
ICM ( Other Identifier: BIOTRONIK )
First Posted: January 19, 2015    Key Record Dates
Results First Posted: April 13, 2023
Last Update Posted: April 13, 2023
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases